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Marketplace Directory

New pathology lab products and industry news from dozens of companies.

Chip prep module, 11/15

November 2015—Agena Bioscience introduced the Chip prep moduleto automate sample handling after polymerase chain reaction for the MassArray 96-well System. This enables laboratories to operate the MassArray System largely unattended for high-throughput, multiplex genetic analysis.

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Micropolymer IHC systems, 11/15

November 2015—Bio SB PolyDetector Systems are highly sensitive micropolymeric detection systems that allow for the demonstration of antigens in formalin-fixed, paraffin-embedded tissues, cryostat sections, blood smears, cytosmears, and cell preparations.

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IHC antibody, 11/15

November 2015—Biocare Medical announced the availability of CK HMW + p63 + AMACR (RM) as an in vitro diagnostic double stain for multiplex immunohistochemistry. This patented antibody cocktail may be useful in the evaluation of normal prostate glands, prostatic intraepithelial neoplasia, and prostatic adenocarcinoma.

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NGS cancer panel, 11/15

November 2015—Illumina has launched TruSight Tumor 15, a next-generation sequencing panel designed to identify sequence variants in 15 genes commonly associated with marketed therapeutics. The sequencing panel is optimized for damaged and degraded formalin-fixed, paraffin-embedded tumor samples, enabling low frequency somatic variant detection from limited nucleic acid inputs.

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KRAS mutation test receives CE-IVD marking, 10/15

Biocartis launched its CE-IVD Idylla KRAS Mutation Test, a sample-to-result test for the fast, accurate, and reproducible detection of 21 relevant mutations in the KRAS oncogene. The fully automated test, for routine use, detects all clinically relevant driver mutations of the KRAS oncogene in tissue of colorectal cancers at a sensitivity of five percent.

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Leukemia fusion genes screening kit, 10/15

QuanDx announced that its Leukemia Fusion Genes (Q30) Screening Kit has been released as a CE IVD product. The Leukemia Fusion Genes (Q30) product is a qualitative in vitro diagnostic kit for use in a clinical laboratory for the simultaneous detection of 30 fusion genes using a novel multiplex reverse transcription real-time PCR system.

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Distribution agreement, 10/15

Lab Sensor Solutions will partner with MarketLab to distribute T-Tracks, which tracks, in real time, the temperature and location of clinical samples in transit, preventing laboratory specimen spoilage and loss and ensuring regulatory compliance. T-Tracks data are delivered to lab personnel’s desktops, laptops, and mobile devices.

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FDA clears seven-day platelet storage, wireless option, 10/15

Terumo BCT has received 510(k) clearance for a labeling change, extending the storage of platelets in plasma from five days to seven days, as well as offering wireless capability for the software applications used with Terumo BCT’s Trima Accel Automated Blood Collection System. This clearance adds to the flexibility and productivity of the Trima Accel system, a device that offers single-needle procedures for a more comfortable donation experience.

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Qiagen, Biotype Diagnostics joint venture, 10/15

Qiagen and Biotype Diagnostics have entered into a partnership to establish Biotype Innovation GmbH. The new company will develop and commercialize molecular diagnostic workflows initially for personalized health care applications based on Qiagen’s proprietary ModaPlex platform, which enables customers to detect, characterize, and measure up to 100 parameters simultaneously.

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Proinsulin and insulin ELISA kits, 10/15

The Insulin and Proinsulin ELISA kits from Enzo Life Sciences allow for the quantitative determination of insulin and proinsulin in serum and plasma. The kits provide a highly sensitive measurement, detecting as little as 0.622 µIU/mL (insulin) and 0.17 pM (proinsulin), deliver fully quantitative results that surpass semiquantitative Western blot analysis, and can analyze up to 40 samples in duplicate in three hours.

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Point-of-care testing standards, 10/15

CLSI released new and revised standards on point-of-care testing in relation to glucose measuring and monitoring. “Effects of Different Sample Types on Glucose Measurements, 1st Edition (POCT06-Ed1)” provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests and is intended for use by clinicians, point-of-care teams, pathologists, laboratory directors, and manufacturers of glucose testing devices.

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Urine preservative product, 10/15

Lab Sensor Solutions will partner with MarketLab to distribute T-Tracks, which tracks, in real time, the temperature and location of clinical samples in transit, preventing laboratory specimen spoilage and loss and ensuring regulatory compliance. T-Tracks data are delivered to lab personnel’s desktops, laptops, and mobile devices.

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Multisystem integration for LIMS, 9/15

MedCompGx, a division of MedComp Sciences, announced the installation and implementation of UniConnect’s Precision MDx laboratory information management system for its new genetic testing lab. The system provides automation of all processes while integrating with multiple systems under one umbrella.

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Intuitive ecosystem for lab support, 9/15

Sysmex announced its Beyond a Better Box product and services model to deliver a comprehensive and intuitive ecosystem that aims to add value to laboratory hematology operations through next-generation diagnostics, advanced tools and technologies, process optimization, and harmonized support known as BeyondCare.

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Flow cytometry control, 9/15

New products featured by Streck this year included CD-Chex CD103 Plus, a flow cytometry control. It includes CD103, CD30, CD38, CD56, CD138, and cytoplasmic lambda in a single control and provides reference values for CD38. The control includes rare leukemia and lymphoma CD markers that are absent in normal whole blood.

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Clinical and workflow IVD solutions, 9/15

Siemens Healthcare Diagnostics revealed its latest IVD solutions, including the Advia Centaur XPT Immunoassay System. Recently FDA-cleared, this high-throughput analyzer is designed to provide continuous operation and seamless connectivity, including to Aptio Automation. The XPT is not available in the U.S.

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Immunoassays, instruments, and controls, 9/15

The family of Phadia instruments from Thermo Fisher Scientific now includes the Phadia 2500E Laboratory System for laboratories meeting high demands. Phadia Laboratory Systems are fully automated instruments for running assays that detect and quantitatively determine clinically relevant antibodies in the blood.

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Rapid test for Ebola, 9/15

The BBI Group developed, in collaboration with the Defence Science and Technology Laboratory, a rapid test for Ebola that is in the process of being verified to allow EUA submission. Using lateral flow technology, BBI’s assay will make testing simpler and quicker than assays that require technical infrastructure.

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Sperm quality analyzer, 9/15

Medical Electronic Systems released its new automated sperm quality analyzer, the SQA-Vision. Developed based on 10 years of market feedback, the SQA-Vision is positioned to augment Medical Electronic’s line of SQA-V and QwikCheck semen analyzers with a top-of-the-line solution.

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Walkaway chemistry analyzer, 9/15

The Diatron Group displayed its new walkaway clinical chemistry analyzer, the Pictus P500. This medium-throughput system (215 tests per hour on a typical sample mix) is ergonomically designed and user-friendly. The advanced, intuitive Windows-based software and smart architecture means the P500 offers many features on an accessible platform including uninterrupted workflow, enhanced walkaway operation, and remote-access diagnostics.

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Automation solutions, 9/15

Festo displayed the EXCM mini H-gantry, its high-speed automated handling system for clinical laboratories. The planar surface gantry system is fast, accurate, modular, and flexible. This plug-and-play system can be used for dosing, barcode-based sample identification, liquid dispensing/pipetting with the addition of a Z-axis, and more. The desktop system moves vials on a planar X/Y axis with absolute positioning accuracy.

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RUO biomarker tests, 9/15

Nuclea Biotechnologies will begin offering more than 50 research-use-only mass spectrometry–based biomarker tests as part of its laboratory services. The tests detect and quantify protein biomarkers in human serum or plasma and are available to pharmaceutical companies for clinical trials, to researchers, and as companion diagnostics.

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Pneumatic tube station, 9/15

Swisslog Healthcare Solutions announced the launch of its Nexus Station. As the next generation of pneumatic tube stations, the Nexus Station provides quiet delivery of PTS carriers and improved carrier management through a carousel that handles both send and receive actions.

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PLAC test, 9/15

Diadexus and Mayo Clinic signed an agreement to collaborate in the areas of education, research, and innovation on the PLAC Test for Lp-PLA2 Activity. The FDA-cleared test is used to identify risk for coronary heart disease in patients with no history of cardiovascular events.

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Analytical and workflow systems, 9/15

Beckman Coulter Diagnostics’ boothBeckman Coulter Diagnostics’ booth showcased its portfolio of high-productivity analytical and workflow systems. Solutions featured in the booth included the Power Express automation solution, the new DxH Connected Workcell, and IRIS International urinalysis solutions for automated urinalysis.

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Resources for in vitro diagnostics, 9/15

The Binding Site announced the formation of its new Immunologicals Group. Formerly known as OEM, this new team will have a broad remit to encompass the sales, marketing, and support of specialist antibodies, antigens, disease state sera, and services to IVD manufacturers, research scientists, and academic facilities.

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FDA clearance for BioMérieux products, 9/15

BioMérieux announced the FDA 510(k) clearance and commercial availability of Vidas 3, the new generation of Vidas. Vidas 3 features enhanced automation, in particular the preanalytical section from the barcoded primary tube including dilution, improved traceability, and new software capabilities, as well as a quality control program in compliance with laboratory certification standards. Vidas 3 is CE marked and registered at the Chinese Food and Drug Administration.

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Benchtop clinical chemistry analyzer, 9/15

EKF Diagnostics launched its Altair 240 clinical chemistry analyzerEKF Diagnostics launched its Altair 240 clinical chemistry analyzer, a benchtop platform that is EKF’s first fully integrated chemistry system for the global market. The fully automated system has LIS bidirectional connectivity, and double arm functionality yields up to 480 tests per hour.

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FDA OKs HIV combo assay, 9/15

The FDA has approved the Siemens Advia Centaur HIV Ag/Ab Combo (cHIV) assay. This latest addition to the Advia Centaur infectious disease menu, which also includes tests for hepatitis A, B, and C, eHIV, syphilis, and other infectious disease assays, enables laboratories to further consolidate their testing to enhance efficiencies.

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Medical billing software, 9/15

Easy Billing announced the newest version of Easy Billing Professional medical billing software. This version features a simple process for storing ICD-9 to ICD-10 crosswalk codes for viewing and selection along with code alerts and discontinued codes.

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Leica microscopes, 9/15

The Leica DM2500 LED is suitable for clinical laboratories and for research applications in microbiology, developmental biology, cytology, zoology, botany, and more. The ultra-bright LED illumination of the DM2500 LED offers a constant color temperature at all light intensities, enabling particularly fine differentiation of colors in stained specimens.

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Multimode microplate reader, 9/15

BioTek released the Synergy Neo2 Multi-Mode Reader, which is designed for speed and ultra-high performance and incorporates BioTek’s patented Hybrid Technology with independent optical paths. Continuously variable bandwidth quadruple monochromators, sensitive high transmission filter-based optics, and up to four photomultiplier tubes provide fast measurements with excellent results, according to a company statement.

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Stable-labeled internal standards, 9/15

Sigma-Aldrich’s Cerilliant brand has introduced five stable-labeled internal standards of the antifungal agents fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole at 1.0 mg/mL concentrations. The reference materials offer clinical and diagnostic testing labs, hospitals, and bioanalytical/pharmacokinetics and drug metabolism labs a full selection of internal standards for quantitation of common antifungal drugs in serum or plasma by mass spectrometry–based analytical methods. ...

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HbA1c calibration verification and linearity test kit, 9/15

Maine Standards released its Validate HbA1c calibration verification/linearity test kit. The kit evaluates percentage of glycohemoglobin A1c in a human-whole-blood base matrix. Each kit is prepared using the CLSI recommended “equal delta” method for linearity testing and is liquid and ready to use—add the product from the dropper bottle directly into a sample cup and run as a patient sample in duplicate or triplicate.

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Clinical expert intelligence system, 9/15

Pacific Knowledge Systems has relaunched in the United States with a suite of solutions based on its patented RippleDown technology, a clinical expert intelligence system that replicates a domain expert’s human decision-making process at scale and with absolute accuracy, according to a company statement.

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E-commerce website, 9/15

PlatinumCode launched an e-commerce website that provides in-depth descriptions of product lines to assist customers in making educated decisions regarding their purchase. The site also offers product-specific landing pages that speak to the features and benefits of the product, as well as the variety of packaging options.

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QuantuMDx licensing opportunities, 9/15

QuantuMDx explored licensing opportunities for its rapid DNA extraction kit Q-PREP at BIO in Philadelphia, which took place in mid-June. Q-PREP is a next-generation DNA extraction technology set to dramatically shorten and simplify the molecular workflow for polymerase chain reaction, sequencing, and other molecular processes. The technology is presently being deployed in next-generation spin columns.

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Fluxion, Swift jointly develop NGS workflow, 9/15

Fluxion Biosciences and Swift Biosciences announced a jointly developed workflow for oncology clinical research designed to detect somatic mutations from a routine blood draw. The workflow uses Fluxion’s IsoFlux System for circulating tumor cell enrichment and Swift’s Accel-Amplicon technology for high-sensitivity variant detection using low starting inputs.

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Laboratory Essentials course, 9/15

Total Lab Care’s Laboratory Essentials course has been approvedT for 3.5 hours of P.A.C.E. continuing education credits. This Web-based interactive training program comprises 10 individual lessons and reviews CLIA rules and regulations and laboratory operations from preanalytical to postanalytical processes, including laboratory testing requirements (pipetting, safety, equipment operation, etc.).

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Biocartis, Fast-track sign strategic collaboration, 9/15

Biocartis and Fast-track Diagnostics have entered into a strategic collaboration to develop a range of multiplex infectious disease tests to run on the Biocartis Idylla system. The two companies plan to collaborate on a new approach to infectious disease diagnostics, “syndromic multiplex testing,” which enables the identification of a broad range of disease pathogens in a single test.

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Solid tumor mutation mix, 9/15

SeraCare Life Sciences’ new precision medicine business unit has launched its first product, the Seraseq Solid Tumor Mutation Mix—I (AF20), a biosynthetic reference material designed to evaluate the performance of next-generation-sequencing–based tumor profiling assays.

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Gene deletion/duplication analysis, 9/15

BloodCenter of Wisconsin’s Diagnostic Laboratories, part of Versiti, announced the availability of genetic deletion/duplication analysis. Using array comparative genomic hybridization (aCGH), this test provides timely detection of deletions and/or duplications that may escape detection with standard DNA sequencing tests. The test allows for the detection of deletions and duplications within a given gene, whether within a single exon, encompassing one or more exons, or the entire gene.

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Quality management system certification, 9/15

Biomedical Polymers has received ISO 13485:2003 certification for its Quality Management System for the manufacture of Medical Devices. In order to meet these requirements for certification, BMP upgraded its quality management system to assist in achieving increased efficiencies, higher performance, and reduced operational costs.

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CLSI Excellence Awards, 9/15

CLSI’s Excellence Awards are bestowed on volunteers who are dedicated and committed to the organization’s mission and who significantly contribute their services to the development, implementation, and promotion of consensus standards. The winners were nominated by their peers and then selected by the CLSI Awards Committee and announced in July.

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c-MET biomarker, 9/15

Biocept launched its c-MET amplification detection test. This diagnostic assay, which uses a blood-based liquid biopsy, has the potential to help physicians identify patients who may be receptive to certain gastric and non-small cell lung cancer treatments.

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Next-generation cell culture line, 9/15

Sarstedt introduced its next generation of cell culture flasks, dishes, and plates redesigned for “superior growth, economic handling, and traceability,” according to a company statement. All items are imprinted with lot number and expiration date and are individually color-coded for one of three culture surfaces. Flasks and dishes are packaged in resealable zip bags, and individual plate packaging has been optimized for easy opening and compact storage.

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Antibody and biomarker search engine update, 8/15

Visabl.com, a cloud-based antibody and biomarker search engine, announced its largest website update. The latest iteration of the Visabl website features several enhancements and improvements to the site and user interface, including a faster targeted search of biomarkers and the ability to dynamically sort and populate results as the user types.

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Clinical chemistry reagents, 8/15

Sekisui Diagnostics launched the Sekure brand of clinical chemistry reagents. Sekisui develops, manufactures, and supplies clinical chemistry reagents and systems to the in vitro diagnostics industry, selling more than 1.5 billion clinical chemistry tests per year.

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Distribution partnership agreements, 8/15

EDP Biotech has entered into distribution agreements with more than 25 distribution channel partners throughout Europe, Asia, and South America. EDP plans a multiphase rollout of ColoMarker, a blood test that aids in the detection of early stage colorectal cancer, in 2015 to gain experience and data in conjunction with key opinion leaders and distributor partners.

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FDA clearance for FecalSwab, 8/15

Copan has obtained FDA clearance for its FecalSwab, which comprises a regular size Copan flocked swab (FloqSwab) and a screw-cap tube containing 2 mL of Cary-Blair medium. FecalSwab is intended for the collection of rectal swabs and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory.

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Center for translational microbiology at ILSE, 8/15

The Institute for Life Science Entrepreneurship and ATCC will collaborate to establish the ATCC Center for Translational Microbiology at ILSE. The focus of the center will be on key challenges identified by both ATCC and ILSE in current translational microbiology, including antimicrobial resistance, synthetic biology, microbial bioinformatics, and the microbiome.

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Ultra-low attachment plate, 8/15

InSphero released its GravityTrap Ultra-low Attachment (ULA) Plate. The automation-compatible 96-well ULA format is well suited for production of 3-D tumor microtissues derived from tumor cell lines or to screen for the propensity of cells to form spheroids in a low-attachment environment.

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Group B strep test receives 510(k) clearance, 8/15

Great Basin Scientific announced the FDA clearance and commercial availability of its molecular diagnostic test for group B streptococcus. The group B strep assay provides accurate results in approximately 90 minutes with a specimen from enriched LIM broth. By targeting a highly conserved region of the cfb (CAMP factor) gene, the molecular assay provides definitive identification and a more rapid diagnosis of the mother’s GBS colonization status compared to standard culture-based tests, which may take up to an additional 48 hours.

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Transgenomic, Horizon OEM agreement, 8/15

Horizon Discovery Group and Transgenomic announced a new original equipment manufacturer agreement to incorporate Horizon’s human genomic reference standards, produced by Horizon’s diagnostics division, into Transgenomic’s Multiplexed ICE COLD-PCR (MX-ICP) kits for use in research and clinical applications. Further details of the agreement were not disclosed.

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Glucose meter cleared for ICU, 8/15

The FDA has cleared Nova Biomedical’s StatStrip Xpress Glucose Hospital Meter System for use throughout all hospital and all professional health care settings, including among critically ill patients. StatStrip Glucose and StatStrip Xpress Glucose are, at press time, the only two hospital blood glucose meters to be cleared by the FDA for use with critically ill patients. StatStrip Xpress Glucose uses the same test strip measurement technology as StatStrip Glucose, which was cleared in 2014 after a four-year study conducted at five university medical centers.

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PerkinElmer, Covaris partnership, 8/15

PerkinElmer’s Chemagic research instrumentation and kits are now available with the Covaris TruXtrac FFPE DNA MicroTube Kit for Chemagen Technology for DNA/RNA purification powered by Adaptive Focused Acoustics technology. The kit rapidly removes paraffin and rehydrates formalin-fixed, paraffin-embedded tissues in an aqueous buffer. This preparation is optimized to work with PerkinElmer’s automated magnetic bead-based DNA/RNA separation technology for low-, medium-, and high-throughput solutions.

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Chinese FDA premarket clearance, 8/15

Hangzhou Berry Genomics, a subsidiary of Berry Genomics, has received premarket clearance from the Chinese Food and Drug Administration for the NextSeq CN500, a high-throughput sequencing instrument developed with Illumina to meet Chinese clinical needs. Hangzhou Berry Genomics also received premarket clearance for its noninvasive prenatal testing detection kit for trisomies 13, 18, and 21.

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Sample management software, 8/15

August 2015—Freezerworks released Freezerworks 2015, a major upgrade of its sample tracking and freezer inventory program. The upgrade offers advanced patient data management and security along with improvements in usability and integrates its two laboratory sample management programs, Basic and Unlimited, into a single platform.

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510(k) clearance for diabetes testing assay, 8/15

August 2015—The FDA has cleared Ortho-Clinical Diagnostics’ Vitros Chemistry Products HbA1c Reagent Kit for use on the Vitros 5600 Integrated System, Vitros 4600 Chemistry System, and the Vitros 5,1 FS Chemistry System. The test can be used for the quantitative determination of percent glycated hemoglobin A1c and mmol/mol hemoglobin A1c in human whole blood.

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Targeted liquid biopsy mutation test, 7/15

July 2015—Biodesix launched GeneStrat, a targeted liquid biopsy mutation test for genotyping tumors of patients with advanced non-small cell lung cancer. Requiring only a blood draw, the test aims to offer a fast, minimally invasive alternative to a high-risk tissue biopsy or re-biopsy in patients with insufficient tissue.

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FDA OKs expanded platelet safety measure testing, 7/15

July 2015—Verax Biomedical has gained FDA clearance to expand the use of its Verax Platelet PGD test—a rapid test for the detection of bacterial contamination in platelets intended for transfusion. The test is an immunoassay used on the day of transfusion at the point of care, a hospital or transfusion service, to quickly detect bacterial contamination in platelets and protect patients from receiving contaminated transfusions.

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Studies support role of BioTheranostics’ tests, 7/15

July 2015—BioTheranostics announced that clinical study data disclosed at the American Society of Clinical Oncology annual meeting in June demonstrate that its CancerType ID molecular cancer classifier and CancerTreatment NGS+ biomarker tests provide actionable genomic information to support an accurate diagnosis and treatment of metastatic cancers.

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Mass spectrometer, software solutions, 7/15

July 2015—Thermo Fisher introduced the Thermo Scientific Orbitrap Fusion Lumos Tribrid Mass Spectrometer, the newest addition to its line of Orbitrap Tribrid mass spectrometers. Designed to expand researchers’ capabilities in advanced proteomics and metabolomics applications, including targeted, data-independent acquisition and top-down analyses, the Orbitrap Fusion Lumos Tribrid has a high level of sensitivity, delivering complete protein sequence coverage and allowing scientists to perform more inclusive analyses.

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Test predicts prostate cancer aggressiveness, 7/15

July 2015—MDxHealth revealed data with the aim of demonstrating the prognostic value of its ConfirmMDx for Prostate Cancer test. The data, offered in two presentations at the American Urology Association’s annual meeting in May, show the test’s ability to identify patients likely to harbor clinically significant prostate cancer from negative biopsy tissue.

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Linearity control assay, 7/15

July 2015—Streck’s Calibration Verification Assessment (CVA) is now assayed for the Horiba ABX Micros 60 instrument. CVA is an assayed linearity control kit used to determine the patient reportable range of three-part and five-part hematology instruments.

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Emergency use Ebola diagnostic test, 7/15

July 2015—Corgenix Medical has received U.S. FDA emergency use authorization for its Re­EBOV Antigen Rapid Test. The test is to be used for the presumptive detection of Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, including geographic locations with high prevalence of Ebola infection.

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Troponin test spots MIs earlier, 7/15

July 2015—Beckman Coulter Diagnostics announced the publication of research results in Clinical Biochemistry (Storrow AB, et al. 2015;48:254–259; 260–267) that identify the precise magnitude of change in cardiac troponin required for early diagnosis of a heart attack using its Access AccuTnI+3 troponin I blood test. Beckman’s troponin-I assay has been clinically proven through a large, multicenter study and is FDA-cleared and directly aligned with the FDA’s October 2010 guidance to manufacturers of troponin tests.

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Molecular standards, 7/15

July 2015—Microbiologics is expanding its line of Helix Elite Molecular Standards with two product formats: inactivated extraction controls and genomic DNA extracts. Used for validation, verification, proficiency testing, and quality control of molecular assays, Inactivated and Genomic Extract controls are available in multiple strains; the first genomic extracts are from low passage mycoplasma strains sourced from the National Collection of Type Cultures.

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Benchtop cryoembedding station, 7/15

July 2015—The patented PrestoChill is an all-dry cryoembedding system from Milestone Medical that does not use liquid nitrogen, CO2, or isopentane. The 60-second freezing time prevents the formation of ice crystals. An automatic defrost cycle is provided to eliminate the potential formation of ice on the freezing platform.

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Study published on VeriStrat proteomic test, 7/15

July 2015—The journal Lung Cancer published a paper demonstrating the economic implications to the U.S. health care system of using VeriStrat in guiding treatment of patients with advanced non-small cell lung cancer. The paper’s authors conclude that using Biodesix’s VeriStrat improves overall survival and decreases medical costs in the U.S. payer system.

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RUO molecular platform, 7/15

July 2015—Rheonix showcased in June its Encompass Optimum research-use-only platform at the 115th General Meeting of the American Society for Microbiology. The Encompass Optimum is an automated system for building and implementing molecular assays as a nonclinical tool.

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Fingerprinting kits for forensic labs, 7/15

July 2015—Qiagen launched two Investigator STR assay kits for analysis of DNA evidence in forensic laboratories in the United States—the Investigator 24plex QS Kit for amplification of the CODIS core and European Standard Set marker sets from casework samples and the Investigator 24plex GO! Kit for direct amplification of the CODIS core and ESS marker sets from reference samples.

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Conical tubes, 7/15

July 2015—Eppendorf has added two screw-cap tubes in 15 mL and 50 mL sizes to its line of Eppendorf Tubes. The newly designed screw caps provide optimal sealing properties, and their grooved and multisurface side contour provide a secure, slip-free grip.

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ELISA kits for TIMP-1 and HGH, 7/15

July 2015—Enzo’s TIMP-1 ELISA kit is designed to provide a useful tool for investigating the TIMP-1 levels in multiple human matrices and aims to advance the studies on TIMP-1 function. The assay format allows for quantitative detection of 30 pg/mL of TIMP-1 in various sample types including serum, plasma, saliva, urine, and tissue culture media.

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BRAF liquid biopsy data, 7/15

July 2015—Biocartis presented liquid biopsy data from the company’s BRAF mutation study at the American Society of Clinical Oncology annual meeting in June. The study, in collaboration with Bart Neyns, MD, PhD, University Hospital Brussels, showed that BRAF oncogene mutations monitored in plasma from metastatic melanoma patients on Biocartis’ Idylla system were significantly associated with treatment response and progression.

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Horizon, ArcherDX sign OEM agreement, 6/15

June 2015—Horizon Discovery Group and ArcherDX have signed an original equipment manufacturer agreement in which Horizon’s reference materials will be supplied as a standalone product alongside ArcherDX’s Archer FusionPlex to aid customer validation of its ALK fusion assay kits. The ALK fusion tests can run on both Illumina and Ion Torrent next-generation sequencing platforms.

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Microbiologics and Microbix partnership, 6/15

June 2015—Microbiologics has entered into an agreement to source inactivated viruses from Microbix Biosystems. Microbiologics will incorporate these inactivated materials into a line of full process controls under its Helix Elite Molecular Standards brand as well as instrument-specific quality control sets.

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Cervical cancer detection assay, 6/15

June 2015—Enzo Biochem announced the development of the FlowScript assay in detection of messenger RNA from HPV oncogenes E6 and E7. The FlowScript technology platform is a proprietary flow-cytometry-based molecular detection system for the multiplex analysis of cell function and identity; the HPV E6/E7 assay is the first product to use this novel platform.

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Third patent awarded for BioDot’s multiple FISH tests, 6/15

June 2015—The U.S. Patent and Trademark Office awarded a third U.S. patent to BioDot for its FISHArray technology and methods. BioDot’s patent family broadly covers technology and methods for performing multiple fluoresence in situ hybridization, immunohistochemistry, and cytogenetic tests on a single substrate, whether performed manually or through automated workstations, such as the company’s CellWriter Workstation.

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Cytomegalovirus test, 6/15

June 2015—Oxford Immunotec announced the availability in the United States of a test that measures the strength of a patient’s cellular immune response to cytomegalovirus. The T-Spot.CMV test is available as a laboratory-developed test from the company’s CLIA-certified and CAP-accredited service laboratory.

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Process management guideline, 6/15

June 2015—The Clinical and Laboratory Standards Institute has published a new document, “Process Management (QMS18-Ed1).” The guideline defines four requirements for managing laboratory processes and provides suggestions for meeting regulatory and accreditation requirements ...

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Dako and Amgen expand collaboration, 6/15

June 2015—Dako, an Agilent Technologies Company, announced a new master collaboration agreement with Amgen. The expanded collaboration will allow both companies to benefit from knowledge sharing within the field of drug-diagnostic research and development and in relation to companion diagnostic products.

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Horizon, Thermo Fisher agreement, 6/15

June 2015—Horizon Discovery Group has signed a supply and commercialization agreement with Thermo Fisher Scientific. Under the terms of the agreement, Thermo Fisher will market and distribute Horizon’s X-MAN human haploid and diploid isogenic cell line collection and will further offer the X-MAN haploid cell line generation service to its worldwide customer base.

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Panel for rapid ID of gene fusions in NSCLC tumors, 6/15

June 2015—Agena Bioscience released the LungFusion Panel for rapid and sensitive identification of oncogenic ALK, RET, and ROS1 gene fusions in non-small cell lung cancer tumors. Using as little as 10 ng of complementary DNA template, the research-use-only, single-well panel identifies expressed translocations of known clinical relevance in formalin-fixed, paraffin-embedded and fresh frozen tissue samples.

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Ventana and Astellas join forces, 6/15

June 2015—Ventana Medical Systems has entered into a master collaboration agreement with Astellas Pharma, a research-and-development–driven pharmaceutical company headquartered in Japan, to develop novel automated tissue diagnostics in support of therapeutic compounds in development.

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Genomic test service for hematologic malignancies, 6/15

June 2015—LeukoVantage, an evidence-based genomic test service that aids in the diagnosis, prognosis, monitoring, and selection of treatment for myeloid neoplasms is now available from Quest Diagnostics. The lab-developed test uses next-generation sequencing, polymerase chain reaction, and other techniques to interrogate DNA from leukocytes in blood or bone marrow specimens for the presence of mutations in 30 genes most frequently associated with myeloid neoplasms.

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Flow cytometry control, 6/15

June 2015—Streck has introduced CD-Chex TdT Plus, a flow cytometry control assayed for TdT, CD1a, CD34, and cCD3. CD-Chex TdT Plus can be used as quality control material for evaluating intracellular and surface antigens including CD1a, CD2, CD4, CD5, CD7, CD8, CD34, cytoplasmic CD3, and nuclear TdT (terminal deoxynucleotidyl transferase).

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FDA-cleared flow cytometer, 6/15

June 2015—Beckman Coulter’s automated Aquios CL Flow Cytometer has received FDA clearance for use in the clinical laboratory. With its small footprint and high precision, the “load and go” instrument has been designed for the Lean laboratory. With integrated automated sample preparation, Aquios CL Flow Cytometer delivers first results within 20 minutes for routine applications such as immunophenotyping.

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Danaher to separate into two businesses, 6/15

June 2015—Danaher Corp. will separate into two independent, publicly traded companies. The transaction will create a science and technology growth company that will retain the Danaher name. Collectively, its businesses generated approximately $16.5 billion in revenues (including Pall Corp., which Danaher has signed an agreement to acquire) in their most recently completed fiscal years.

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Thermo Fisher Scientific and Samsung collaborate, 5/15

May 2015—Thermo Fisher Scientific and Samsung Electronics have formed a strategic collaboration to jointly design, develop, and market new point-of-care solutions in key applications, such as the detection of sepsis, drugs of abuse, and therapeutic drug monitoring as well as the detection of cardiac problems and women’s health conditions.

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Siemens adds three hematology systems, 5/15

May 2015—The diagnostics division of Siemens Healthcare announced the launch of three scalable hematology systems: the Advia 360 System, Advia 560 System, and Advia 560 AL System. These lower-capacity systems offer testing capabilities for small to mid-size laboratories and may also be used as backup systems for larger laboratories.

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Process management guideline, 5/15

May 2015—The Clinical and Laboratory Standards Institute has published a new document, “Process Management (QMS18-Ed1).” This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and contributing to patient safety and positive outcomes.

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Cervical cancer detection assay, 5/15

May 2015—Enzo Biochem announced the development of the FlowScript assay in detection of messenger RNA from HPV oncogenes E6 and E7. The FlowScript technology platform is a proprietary flow-cytometry-based molecular detection system for the multiplex analysis of cell function and identity; the HPV E6/E7 assay is the first product to use this novel platform. Analysis is performed on a small volume of a liquid cytology specimen and can be incorporated as a reflex test measure following abnormal Pap smear results.

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Methotrexate ELISA kit, 5/15

May 2015—The Methotrexate ELISA kit from Enzo Life Sciences enables the monitoring of methotrexate levels during treatment of cancer and rheumatoid arthritis. The assay is also appropriate for the detection of methotrexate contamination after its use as a selective agent for recombinant protein production in mammalian cell lines.

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Diabetic biomarker test, 5/15

May 2015—EKF Diagnostics has introduced the Stanbio Chemistry Glycated Serum Protein LiquiColor test, a diabetic biomarker test that provides a two- to three-week indicator of average blood glucose, closing the information gap between daily blood glucose testing and the two- to three-month HbA1c reading. GSP serves as an accurate intermediate marker of glycemia in instances where HbA1c may be of limited value, such as pregnancy, reduced RBC lifespan, and hemodialysis.

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Urine collection systems, 5/15

May 2015—Sarstedt is offering two urine collection systems—the Urine Monovette and the V-Monovette. The Urine Monovette enables hygienic urine collection and testing without needles, adapters, or cups or transfers. All tubes are manufactured from impact-resistance, medical-grade plastics and feature secure screw caps for safe handling. After collection using a syringe technique, the plunger handle is removed to create a primary tube for transport, direct analysis, and centrifugation. A Luer-lock version is also available for needleless collection from Foley catheters.

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IQCP tool, 5/15

May 2015—Radiometer has announced the launch of a dedicated Individualized Quality Control Plan tool for hospitals using the ABL90 Flex blood gas analyzer. The IQCP tool provides a template for hospitals with ABL90 Flex analyzers to develop a customized quality control plan. Starting at the preanalytical phase, the tool next guides the laboratorian through the analytical and postanalytical processes, identifying key areas of focus to ensure the development of an IQCP program that is right for each institution.

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DPA lauds FDA draft guidance, 5/15

May 2015—The Digital Pathology Association is commending the FDA for developing and releasing draft guidance that provides industry and agency staff with recommendations regarding the technical performance assessment data that should be submitted for regulatory evaluation of a digital whole-slide imaging system.

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Qiagen acquires CTC technology, 4/15

April 2015—Qiagen has expanded its portfolio of liquid biopsies through the acquisition of a proprietary technology from AdnaGen. The technology allows a complete solution for the detection and analysis of circulating tumor cells for clinical applications. It enriches disease-specific tumor cells using magnetic particles in an antibody mixture, then isolates and purifies messenger RNA for analysis using reverse transcription polymerase chain reaction.

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Advia Centaur syphilis assay now available in the U.S., 4/15

April 2015—The diagnostics division of Siemens Healthcare has announced the U.S. availability of its Advia Centaur Syphilis assay to be used as a diagnostic aid. The assay, which allows for sensitive and specific detection of antibodies to the proteins of Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, sodium citrate), is available on the company’s Advia Centaur, Centaur XP, and Centaur CP immunoassay systems. It is not intended for blood and tissue donor screening.

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Rosetta Genomics, Precipio commercial partnership, 4/15

April 2015—Rosetta Genomics has entered into a co-promotional commercial partnership with Precipio Diagnostics for the sales and marketing of Precipio’s oncology tests, which include bone marrow and peripheral blood testing for hematological malignancies, such as leukemias and lymphomas. These products are being promoted by Rosetta in California, Connecticut, New Jersey, Oklahoma, Texas, Virginia, and Washington, DC, with an expectation to expand nationally over time.

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RNA fusion lung cancer research panel, 4/15

April 2015—Thermo Fisher Scientific has released a next-generation sequencing RNA panel and workflow that enables targeted sequencing of fusion transcripts for clinical research. The Ion Torrent AmpliSeq RNA Fusion Lung Cancer Research Panel allows simultaneous sequencing of 70 ALK, RET, ROS1, and NTRK1 fusion transcripts associated with lung cancer as well as 5’ and 3’ ALK gene expression.

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Image analysis software, 4/15

April 2015—Definiens announced the newest version of its image analysis software for quantitative digital pathology, Tissue Studio 4.0. By providing morphological fingerprints and biomarker expression profiles on a cell-by-cell basis, the software enables comprehensive and consistent data for any tissue-based assay. It is also able to handle biological variation and staining heterogeneity.

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Four new systems from Illumina, 4/15

April 2015—Illumina has launched the HiSeq X Five System and HiSeq 3000/4000 systems and has introduced the NextSeq 550 System, an NGS system enabled for array scanning. The HiSeq X Five System is designed for laboratories wanting to take advantage of HiSeq X technology for human whole genome sequencing at a smaller scale. At full utilization, the system, which consists of five individual HiSeq X instruments, provides the throughput to sequence more than 9,000 genomes a year.

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Antimicrobial susceptibility testing standards, 4/15

April 2015—The Clinical and Laboratory Standards Institute released a new edition of its annual supplement “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement (M100-S25).” This document provides the revised breakpoints, new testing recommendations, and reporting changes needed to incorporate into routine practice for improving detection and reporting of antimicrobial resistance.

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GenomeDx implements Clarity LIMS, 4/15

April 2015—Genologics announced that GenomeDx Biosciences has implemented Genologics’ laboratory information management system, Clarity LIMS, to support whole transcriptome analysis workflows as part of GenomeDx’s mission to address unmet clinical needs in the management of prostate cancer. Headquartered in Vancouver, BC, GenomeDx will use Clarity LIMS in its CLIA-certified lab in San Diego.

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Guide for the FDA’s regulation of LDTs, 4/15

April 2015—The Clinical and Laboratory Standards Institute has published “Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.” The guide is intended to clarify how to implement the Quality System Regulation, 21 CFR 820, that may be required for some classifications of LDTs.

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Ro (SSA) antigen, 4/15

April 2015—The Binding Site, through its arrangement with Arotec Diagnostics, offers an Ro (SSA) antigen designed for use as a component in solid phase ELISA-based immunoassay test procedures for the detection of anti-Ro (SSA) antibodies for use in research and in vitro diagnostic manufacturing applications.

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Scalable RNA sequencing service line, 4/15

April 2015—Beckman Coulter Genomics has added stranded, ribodepletion and globin reduction library construction options to its existing RNA-Seq services. The Illumina TruSeq Stranded Total RNA Sample Prep Kit has been validated at Beckman Coulter Genomics for human, mouse, rat, and plant samples and automated on Beckman Coulter instruments to enable scalability and LIMS sample tracking. In addition, it includes the ability to work with samples derived from blood and formalin-fixed, paraffin-embedded tissue.

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Mounting media with phalloidin, 4/15

April 2015—This special formulation of Vector Labs’ VectaShield HardSet Mounting Medium, which prevents photobleaching of fluorescent proteins and fluorescent dyes, contains TRITC-phalloidin. Phalloidin is a bicyclic heptapeptide that specifically binds actin filaments within a cell.

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NGS solution for forensic genomics, 3/15

March 2015—Illumina launched the MiSeq FGx Forensic Genomics System, a fully validated forensic next-generation sequencing system that simultaneously interrogates short tandem repeats and other valuable genetic markers, including single nucleotide polymorphisms, to provide informative DNA profiles. The system enables robust analysis of a range of genetic markers in a single workflow.

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FDA clearance for blood bank software solution, 3/15

March 2015—BBCS received 510(k) clearance for its ABO Wheels, a blood bank software solution that is part of the company’s ABO Suite. ABO Wheels is a mobile blood-collection application that allows blood centers to conduct paperless donor registration and screening at either a collection facility or a non-fixed site, regardless of connectivity to the main database.

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CE-IVD tumor panel for NGS, 3/15

March 2015—The CE-IVD Oncomine Solid Tumor DNA kit from Thermo Fisher Scientific enables accurate and reliable multiplexed sequencing of formalin-fixed, paraffin-embedded tumor. Based on the Ion Torrent AmpliSeq technology, the kit allows detection of single nucleotide somatic changes, inversions, insertions, and deletions using as little as 10 ng of FFPE DNA ...

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Collection systems for medical labs, 3/15

March 2015—Transworld Systems, a cash-flow management and profit recovery company, announced a dedicated division to work with medical laboratories. Profit Recovery and Profit Recovery Plus are flat-fee, automated collection systems that generate diplomatic, written demands from a third party. According to the company, flat-fee written contacts are getting outstanding results in the low-balance, high-volume environment laboratories create. The initiative is headed by Michael Paro, accounts receivable advisory specialist for medical labs.

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FDA clears test for CHD events, 3/15

March 2014—The Food and Drug Administration cleared a screening test that predicts a patient’s risk of future coronary heart disease events, such as heart attacks. The test is cleared for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black women.

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Bioprocess control station, 3/15

March 2014—The BioFlo 320 from Eppendorf is built with integrated control for both autoclavable and single-use vessels with a total working volume of 250 mL to 40 L on a single control platform. Ethernet communication connects up to eight systems from a single user interface for multi-unit control, and the Mettler-Toledo Intelligent Sensor Management platform is built into the system.

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Emergency prep guidelines, 3/15

March 2014—The Clinical and Laboratory Standards Institute has published a new document, “Planning for Laboratory Operations During a Disaster; Approved Guideline (GP36-A).” The document provides guidance for laboratory and health care leadership for development, implementation, and sustainment of effective emergency preparedness plans (all hazards) supporting nonanalytical components of clinical and public health laboratory services that may pertain to various natural and manmade disasters.

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Point-of-care CBC system, 3/15

March 2014—The Ativa microlab from Ativa Medical is a point-of-care device designed to perform the most common blood-based tests in a clinical setting in five minutes. The system requires only a few drops of blood and runs on a disposable microfluidic card.

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POC cardiac analyzer, 3/15

March 2014—The Diagnostics Division of Siemens Healthcare is unveiling its latest point-of-care acute care analyzer for the management of patients with cardiovascular disease symptoms. The company’s Stratus CS 200 Acute Care Diagnostic System is designed for simple operation and instrument management at the point of care to help facilitate rapid decision-making and provide optimal patient care.

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Quest, CDC collaborate to improve hepatitis care, 3/15

March 2014—Quest Diagnostics will collaborate with the Centers for Disease Control and Prevention to identify trends in screening, diagnosis, and treatment for four strains of viral hepatitis in the U.S. Under terms of the multiyear contract, Quest will provide CDC researchers with analytics expertise and access to the company’s national Health Trends database of de-identified clinical testing hepatitis data.

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Histamine ELISA kit, 3/15

March 2014—Enzo Life Sciences’ Histamine ELISA kit provides a quantitative detection method for measuring histamine in human, rat, mouse, and canine samples. Because of histamine’s potent role in the immune response, it is present in a transitory state in the body and can only be measured within minutes of release. The half-life of histamine in a biological system is four minutes before its conversion to n-methyl histamine.

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Analytical and precision balances, 9/14

September 2014—Ohaus will launch in September its Adventurer line of analytical and precision balances for standard laboratory weighing. Adventurer has nine application modes, including weighing, percent weighing, counting, check weighing, dynamic weighing, totalization, formulation, density determination, and display hold.

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Hemoglobin analyzer, plasma centrifuge, 9/14

September 2014—EKF Diagnostics highlighted its expanding product portfolio at its subsidiary’s booth, Stanbio Laboratory. DiaSpect Tm, which previewed at the meeting, is a palm-sized hemoglobin measurement system that gives laboratory-quality performance for anemia screening. Delivering results in one to two seconds, this analyzer is CE marked and currently undergoing FDA approval.

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Protagen, Qiagen agreement, 2/15

February 2014—Protagen has entered into a long-term collaboration agreement with Qiagen to target the development of novel protein-based companion diagnostics for autoimmune disorders. Under the terms of the agreement, Qiagen will gain access to Protagen’s proprietary SeroTag technology platform, which enables the discovery and validation of novel protein-based marker panels.

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Electronic data management system, 2/15

February 2014—Title21 Health Solutions released its Cellular Therapy Solution, which enables cellular therapy environments, transplant centers, and cord blood banks to achieve traceability, enhance quality controls, and streamline the life cycle of therapeutic products in an easy-to-use platform.

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Chembio agreement with CDC contractor, 2/15

February 2014—Chembio Diagnostics has entered a follow-on, milestone-based development agreement with a private contracting organization acting on behalf of the Centers for Disease Control and Prevention for a multiplex POC influenza immunity test using Chembio’s patented Dual Path Platform technology.

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Ebola antigens, antibodies for ELISA, 2/15

February 2014—Meridian Life Science offers several products suitable for the development of an ELISA detection assay for Ebola. The new Ebola reagents are C01762M MAb to Ebola virus, C86037M MAb to Ebola virus, C86180M MAb to Ebola virus, R01577 Ebola Zaire Nucleoprotein (E. coli) recombinant, and R01578 Ebola Sudan Nucleoprotein (E. coli) recombinant.

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EKF, Joslin Diabetes Center collaboration, 2/15

February 2014—EKF Diagnostics has entered a multiyear collaborative relationship with Joslin Diabetes Center in support of the ongoing clinical and commercial translation of tumor necrosis factor receptor 1 and 2 biomarkers. EKF will access certain clinical and research expertise at Joslin under the center’s corporate liaison program to further develop its TNFR biomarker test.

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Auto-loading cassette printer, 2/15

February 2014—Primera Technology’s robotic-based, auto-loading version of the Signature Cassette Printer, model SCP-R, is now available. Signature Cassette Printer is designed for use in pathology and histology labs to print high-resolution text, graphics, and barcodes on tissue cassettes. It uses thermal transfer ink ribbons instead of solvent ink-jet or laser ablation.

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Updated nongynecological cytology specimens standard, 2/15

February 2014—The Clinical and Laboratory Standards Institute has released Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition (GP23-A2). This document provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimens to ensure suitable specimens for diagnosis of cancer, infectious diseases, and other inflammatory conditions. CLSI, 610-688-0100

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Cell imager, 2/15

February 2014—BioTek Instruments introduced the Cytation 5 Cell Imaging Multi-Mode Reader. The cell imager combines automated digital widefield microscopy with conventional multimode microplate detection.

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Genotyping analyses application, 2/15

February 2014—AgileBio released an add-on for LabCollector called SNP Manager, which is dedicated to the treatment of single nucleotide polymorphism genotyping workflows. Users can generate picking lists and instructions files for tube pickers (Tube Sorter and Floyd 2D) and genotyping process (Fluidigm EP1) machines.

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FDA-cleared multianalyte control, 2/15

February 2014—The FDA has cleared Randox’s Acusera Liquid Assayed Chemistry Premium Plus, a multianalyte control containing 100 commonly used analytes, for use in U.S. laboratories. Randox believes the “super control” will revolutionize quality control in laboratories, saving time and money while ensuring accurate results and patient diagnosis.

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Automated thawing system, 2/15

February 2014—BioCision announced the availability of the ThawStar automated sample thawing system, designed to standardize the “last mile” in the cryopreservation process. Using the patent-pending Star sensing technology, the ThawStar system tailors the thaw cycle to the specific characteristics of each frozen sample.

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Thermo Fisher, Cynvenio distribution agreement, 2/15

February 2014—Thermo Fisher Scientific has signed an agreement with Cynvenio Biosystems, a molecular testing company focused on the genomic analysis of tumor biomarkers in the bloodstream, for rights to distribute its LiquidBiopsy platform. The automated LiquidBiopsy platform is designed to extract and isolate circulating tumor cells from a standard blood draw in preparation for high-content imaging and genomic analysis.

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Drug-testing platform, 2/15

February 2014—Siemens Healthcare announced the launch of its drug-testing platform designed to meet the productivity, workflow, and workspace needs of mid-volume laboratories—the Viva-ProE System with EMIT technology. The system features a benchtop design with a compact footprint for smaller workspaces, has a capacity for 50 sample and 12 auxiliary positions, and can run up to 133 EMIT tests per hour.

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First commercial services from Aperiomics, 2/15

February 2014—Aperiomics introduced its Absolute-NGS Pathogen Detection Platform, a package of three next-generation sequencing services for the identification of known and unknown pathogens, whether bacteria, virus, fungus, or parasite. From a single test, Aperiomics’ technology can simultaneously test for all pathogens using an unbiased sequencing and genomic analysis approach.

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HIV-1/2 supplemental assay, 2/15

Bio-Rad Laboratories’ Geenius HIV-1/HIV-2 Supplemental Assay, which received premarket application approval from the FDA, can differentiate circulating antibodies to HIV types 1 and 2 in whole blood, serum, and plasma. The assay offers a three-step procedure that produces onscreen results in 30 minutes with full traceability.

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FDA clearance for vitamin D assay, 2/15

Beckman Coulter Diagnostics has received FDA 510(k) clearance for the Access 25(OH) Vitamin D Total assay. The assay is available for use on the company’s Access 2 and UniCel DxI series of immunoassay systems and provides excellent stability and convenient storage through packaging designed to prevent light-induced reagent degradation.

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Roche purchases tissue dissection technology, 2/15

February—Roche Diagnostics has signed a definitive purchase agreement with AvanSci Bio for all products associated with the high-performance microdissection of slide-mounted tissue sections. The system consists of instrumentation, software, and consumables used by researchers and clinicians to extract specific areas of tissue with high precision and purity for subsequent molecular analysis including real-time PCR, microarrays, and sequencing.

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Stain QC slides, 2/15

February 2014—Alpha-Tec Systems’ Stain Quality Control Slides are designed to ensure the quality, accuracy, and reliability of stain reagents and staining procedures. The slides provide a known positive and negative control that the laboratory can use to limit the batch-to-batch differences in staining procedures and standardize diagnostic criteria.

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NSCLC blood-based liquid biopsy test

January 2015—Biocept launched its lung cancer liquid biopsy testing, performed at its CLIA-certified, CAP-accredited laboratory. The blood-based biomarker testing for non-small cell lung cancer, along with the previously commercialized breast cancer offering, provides options for health care professionals and researchers for when a tumor biopsy is not available or is unsafe to perform or when additional information is desired.

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Claritas, NextCode Health partnership

January 2015—Claritas Genomics and NextCode Health announced a strategic partnership bringing together pediatric medicine and sequence analysis. Claritas Genomics, affiliated with Boston Children’s Hospital, is a CLIA-certified clinical laboratory serving the DNA-based diagnostic testing needs of children’s hospitals.

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Beckman Coulter Genomics integrates Clarity LIMS

January 2015—Beckman Coulter Genomics has integrated a Genologics Clarity LIMS into its Illumina HiSeq-based next-generation sequencing workflows. RNA sequencing, target capture, whole-genome sequencing, and pre-made library samples are tracked by the laboratory information management system from acquisition through quality control, library prep, and Illumina sequencing. Sample handling is provided for all workflows and chain-of-custody information is preserved.

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Tuberculosis test kit

January 2015—The TB MODS Test Kit, from Hardy Diagnostics, uses the microscopic observation of drug susceptibility (MODS) method to simultaneously detect Mycobacterium tuberculosis and the strain’s resistance to two common tuberculosis antibiotics—isoniazid and rifampicin.

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CLSI updated standards and software

January 2015—The Clinical and Laboratory Standards Institute has published two updated standards and released a new version of its StatisPro software. User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition (EP15-A3) describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed in five days.

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Immunoassays for hydrocodone detection

January 2015—Thermo Fisher Scientific launched its DRI Hydrocodone/Hydromorphone Assay, a homogeneous enzyme immunoassay that specifically detects hydrocodone and major metabolites in human urine at a 300 ng/mL cut-off. The assay uses liquid ready-to-use reagents, calibrators, and controls and can be run in qualitative and semiquantitative modes.

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Leica acquisition

January 2015—Leica Biosystems has completed its acquisition of Devicor Medical Products. The Cincinnati-based company has annual revenues of approximately $170 million and more than 550 employees.

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Partnerships to develop POC diagnostic tests

January 2015—Chembio Diagnostics announced it has entered into an exclusive agreement with Integrated BioTherapeutics, a biotechnology company focused on the discovery of novel vaccines and therapeutics for emerging infectious diseases. Under the terms of the agreement, Chembio will combine its patented Dual Path Platform technology with IBT’s proprietary Ebola reagents to develop POC diagnostic tests for Ebola and febrile illness. Chembio will have exclusive rights to any POC product developed through this agreement.

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Expanded platforms for hemoglobin A1c test

January 2015—Beckman Coulter Diagnostics has launched its next-generation Hemoglobin A1c assay with improved performance across its chemistry systems. The assay has been standardized for use on all platforms of the company’s AU clinical chemistry systems for off-line sample preparation use and for online sample preparation use on the company’s UniCel DxC systems and is FDA 510(k) cleared for both analyzers.

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Medical equipment financing

January 2015—Cornerstone Medical and Technology Finance specializes in assisting small medical practice owners obtain capital. Cornerstone can customize financing programs for pathologists who would like to remodel, expand, or relocate their office or to purchase additional equipment.

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Monoclonal antibody patent issued

January 2015—Biocare Medical has been awarded a U.S. patent for its anti-PAX8 mouse monoclonal antibody, clone [BC12]. The PAX8 antibody [BC12] is designed to target a restricted epitope and exhibits higher specificity and provides sharper staining than the PAX8 rabbit polyclonal antibody.

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Emergency-use Ebola virus kit

January 2015—Qiagen will offer global distribution of the RealStar Ebolavirus RT-PCR Kit 1.0. The diagnostic kit, developed and manufactured by Altona Diagnostics, is a reverse transcription polymerase chain reaction test intended for the qualitative detection of RNA from all known strains of Ebola viruses. Qiagen will distribute the kit and Altona’s already CE-IVD marked test, the RealStar Filovirus RT-PCR Kit, which is for both Ebola and Marburg viruses and does not fall under the emergency use authorization.

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Advanced Cell Diagnostics awarded NCI grant, 12/14

December 2014—Advanced Cell Diagnostics has been awarded a two-year, $1.4 million grant from the National Cancer Institute under its Small Business Innovation Research Grant phase two program. ACD and its academic partner, Cleveland Clinic, will use the grant to develop and validate a diagnostic test based on ACD’s proprietary RNAscope technology for discriminating various B-cell non-Hodgkin lymphomas from benign lymphoproliferative diseases.

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Reagent kits, 12/14

December 2014—Illumina announced new reagent kits for the HiSeq X Ten and HiSeq 2500 sequencing systems. For HiSeq X Ten Systems, the HiSeq X HD v2 Reagent Kit adds flexibility to population-scale human whole-genome sequencing by supporting an expanded menu of library preparation options.

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Affymetrix, Ariosa Diagnostics sign supply agreement, 12/14

December 2014—Affymetrix and Ariosa Diagnostics announced the signing of a multiyear supply agreement covering Affymetrix arrays and instruments to be used as part of Ariosa’s Harmony Non-Invasive Prenatal Test. The partnership enables Ariosa to pursue the development of a Harmony test kit that will allow laboratories worldwide to adopt and perform this test.

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EKF Molecular, MGH announce collaboration, 12/14

December 2014—EKF Diagnostics announced it has entered a two-year research collaboration with Massachusetts General Hospital to develop PointMan assays that can detect treatable cancer mutations in blood samples. MGH will use PointMan DNA for the detection of genetic variation in circulating tumor cells isolated from a patient’s blood using MGH’s CTC-Chip instrument.

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Horizon acquires Sage Labs, 12/14

December 2014—Horizon Discovery Group announced it has agreed to acquire Sage Labs for up to $16 million in cash and up to $32 million through the issue of new ordinary shares. The acquisition of Sage, a provider of next-generation research models, builds on the acquisition of CombinatoRx in July.

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Blast freezers, 12/14

December 2014—The Thermo Scientific XBF40 series of -40°C blast freezers are for rapid cooling during the sample preparation process, prior to freezer storage. Available in two options, the XBF40D-MD is designed for rapid plasma freezing and accommodates plasma bags, boxes, and bottles, and the XBF40D is for general-purpose applications and accommodates staggered loads and a variety of vessels, such as carboys, bottles, racks with vials, and more.

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Software and informatics solution updates, 12/14

December 2014—To support users focused on hereditary disease, Qiagen has fully integrated Biobase HGMD Professional with Ingenuity Variant Analysis so that researchers no longer require a separate human gene mutation database license. The Ingenuity Variant Analysis is a Web-based software application that filters genetic variants in a secure, private, cloud-based environment to identify variants most likely to cause disease.

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Orbitrap-based mass spectrometer, 12/14

December 2014—Laboratories performing food and environmental testing, clinical research, forensic toxicology, pharmaceutical or biopharmaceutical measurements, and other applied analyses can now benefit from the performance of high-resolution accurate-mass (HRAM) Orbitrap mass spectrometry using an instrument designed for cost-per-sample-sensitive workflows.

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Next-gen multiplex biomarker analysis platform, 12/14

December 2014—MyCartis announced the launch of Evalution, a digital multiplex analysis platform tailored to clinical research and pharmaceutical markets and designed to analyze a broad range of protein and nucleic-acid-based biomarkers. Evalution provides an integrated reaction and detection environment and simultaneous analysis of large numbers of analytes per assay.

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Instrumentation added to assays, 12/14

December 2014—Streck’s A1c-Cellular Linearity, an HbA1c linearity/calibration verification material with intact red blood cells, is now assayed for the Trinity Biotech Premier Hb9210 and Ultra2 instruments. A1c-Cellular Linearity is a five-level assayed linearity material used to assess instrument accuracy and verify the patient reportable range of the HbA1c parameter.

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CE marking for digital pathology solution, 12/14

December 2014—Royal Philips announced it has acquired the CE mark for the diagnostic use of its Philips Digital Pathology Solution. European pathologists will now be able to use the full digital solution as an aid in diagnosis for routine pathology, including hematoxylin and eosin, immunohistochemistry, and special stained tissue sections.

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Interpretation software for NGS diagnostics, 12/14

December 2014—Omicia, a genome interpretation company, announced the commercial availability of Opal Clinical, the company’s software-as-a-service solution for diagnostic testing organizations. With Opal Clinical, users can launch NGS tests faster and interpret results more accurately and quickly, the company said in a statement.

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OvaGene, Hitachi Chemical to collaborate, 12/14

December 2014—OvaGene Oncology announced it has entered into a research and development collaboration with Hitachi Chemical Research Center to bring novel mRNA-based signatures to the gynecologic oncology market. The collaboration is founded on Hitachi Chemical’s patented exosome technologies and OvaGene’s research, clinical validation, and translational focus.

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Imaging and telepathology workstation, 12/14

December 2014—The PathScope 2 microscope imaging system from SPOT Imaging Solutions is designed to save pathologists up to two minutes per slide by streamlining routine slide examination. One click of the HistoSnap button captures the image during slide examination and imprints the image with the case number and reference mark, and then archives it to the laboratory information system, file server, or cloud storage.

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NGS system CE marked for IVD use, 12/14

December 2014—Thermo Fisher Scientific announced the successful CE-IVD registration of its Ion PGM Dx System for sale in European countries. The system was developed using the Ion Torrent next-generation sequencing technology, currently used in clinical research laboratories to produce tests to uncover meaningful genetic information for a range of human conditions.

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High-risk HPV test, 12/14

December 2014—Abbott’s DNA test for the detection of high-risk human papillomavirus is now available in Europe. The test identifies women at increased risk for development of cervical cancer or the presence of high-grade disease.

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EU launch of HER2 ISH assay, 11/14

November 2014—Dako, an Agilent Technologies company, announced the EU launch of HER2 IQFISH pharmDx automated on Dako Omnis. The assay will enable pathology laboratories to integrate the Dako HER2 IQFISH and IQFISH hybridization buffer into their immunohistochemistry workflow.

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NGS oncology quality control, 11/14

November 2014—Clinical laboratories running next-generation sequencing oncology tests now have access to a universal quality control material compatible with multiple sequencing platforms. The AcroMetrix Oncology Hotspot Control from Thermo Fisher Scientific provides a common quality control material that can be used in laboratories with different NGS instrument platforms, assays, and bioinformatics pipelines to test precision and detect analytical deviations that may arise from reagent and instrument variation.

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Microplates, 11/14

November 2014—BrandTech Scientific announced the availability of inertGrade microplates for the cultivation of nonadherent cell lines, spheroids, and stem cells in a 96-well plate format. The polystyrene plates are treated with a proprietary hydrogel that creates a hydrophobic interface between the surface of the plastic and cellular material to inhibit cell and protein attachment.

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Gene expression panel for immuno-oncology research, 11/14

November 2014—NanoString Technologies announced a highly multiplexed gene expression panel for the nCounter Analysis System, the PanCancer Immune Profiling Panel. The panel will enable researchers to create profiles of the human immune response in all cancer types, potentially accelerating the discovery and development of drugs, therapies, and predictive biomarker signatures for immunotherapy treatment response.

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Tissue-specific optimized AAV plasmids, 11/14

November 2014—Sirion Biotech, in cooperation with University of Munich and University of Cologne, developed a line of viral vectors with specific promoters that are only active in a targeted set of cells to initiate the desired gene expression. Using this method, the gene of interest is being expressed only in the targeted tissue relevant to the desired therapy. The method is designed to improve the effectiveness of therapy and reduce the likelihood of side effects.

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Erythroid chimerism test, 11/14

November 2014—BloodCenter of Wisconsin’s diagnostic laboratories announced the availability of its erythroid chimerism test to monitor erythroid lineage chimerism in patients with sickle cell disease following allogeneic bone marrow transplantation.

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FDA OKs marketing of AKI risk-assessment test, 11/14

November 2014—The Food and Drug Administration is allowing the marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury in the 12 hours following administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death, according to the agency.

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GenoLogics enters agreement with Illumina, 11/14

November 2014—GenoLogics has been selected by Illumina as the laboratory information management system provider to support customers of the HiSeq X Ten sequencing system. Under the agreement, the companies will provide support for HiSeq X Ten whole-genome workflows and analysis pipelines, including those to be used inside of Illumina.

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Microsampling device, 10/14

October 2014—Neoteryx announced the launch of the Mitra (RUO) Microsampling Device for the collection, transport, storage, and analysis of biological fluids. In seconds, the research-use-only Mitra microsampler consistently collects 10 µL of fluid while eliminating the volumetric blood hematocrit bias typically associated with the dried blood spotting technique.

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Utilization management solution, 10/14

October 2014—Viewics released its Utilization Management solution specifically designed for laboratories. The Viewics solution enables laboratories and pathology groups to leverage massive amounts of data into customized dashboards, analyses, and insights that drive successful utilization management initiatives.

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Gene expression kit, 10/14

October 2014—The Cells-to-CT 1-Step Power SYBR Green Kit from Life Technologies makes it possible to perform expression analysis directly from cultured cells without RNA purification. This new addition includes cell lysis reagents with gDNA removal and the Power SYBR Green 1-Step RT-PCR master mix.

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Multichannel pipettes, 10/14

October 2014—The Viaflo Assist is a multichannel pipette from Integra that works with Viaflo II electronic pipettes to prevent users from repetitive strain injuries and to significantly increase the reproducibility of prolonged pipetting protocols such as serial dilutions, plate fillings, and reagent addition.

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Standard on microbiological transport systems QC, 10/14

October 2014—The Clinical and Laboratory Standards Institute released a new edition of its document Quality Control of Microbiological Transport Systems; Approved Standard—Second Edition (M40-A2). This document provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens.


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Pneumococcal array, 10/14

October 2014—Quansys Biosciences is releasing Q-Plex Pneumococcal Array (14-plex) for the evaluation and detection of IgG antibody concentrations to pneumococcal polysaccharide serotypes 1, 3, 4, 6B, 7F, 8, 9N, 9V, 12F, 14, a8C, 19A, 19F, and 23F.

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Tissue, chromatography, and high-recovery vials, 9/14

September 2014—Wheaton’s CryoElite Tissue Vials are designed for the safe, secure, and effective cryopreservation of biological tissue specimens and are able to maintain sample integrity while maximizing storage capacity and organization. CryoElite Tissue Vials were developed for the high-performance tissue banking requirements of anatomical pathology departments, clinical trial organizations, and biorepository and biobanking facilities.

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High-speed sorters, 9/14

September 2014—AutoSorter 2000BB is Yaskawa Motoman’s new high-speed bulk sorter for high-volume commercial laboratories. AutoSorter 2000BB provides specimen throughput of up to 2,000 tubes per hour. It minimizes manual handling of specimens through bulk loading and unloading, and reduces sequential sorting by fine sorting in one step.

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Laboratory solutions, 9/14

September 2014—Beckman Coulter Diagnostics showcased five laboratory solutions in its booth, which was themed “New Laboratory Challenges Require New Thinking”: the Power Express automation solution consolidates immunoassay, hematology, and coagulation; the DxH Connected Workcell offers labs workflow management while delivering comprehensive and accurate patient results; the latest addition of the IRIS International urinalysis portfolio; the Remisol Advance enterprise data management system; and its immunoassay diagnostic testing menu, which includes AccuTnI+3 troponin I in the cardiac panel, the Prostate Health Index (phi) as part of the men’s health panel, and a complete reproductive panel.

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Roche products and acquisitions, 9/14

September 2014—New products featured by Roche this year include analyzers, an automated workflow series, and assays. The Cobas u 601 urine analyzer is a fully automated solution for urine strip testing in mid- to high-volume labs that delivers high-quality results through reagent test strips. This analyzer is not available for sale in the U.S.; a 510(k) submission is pending.

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Women’s health care lab, 9/14

September 2014—Medical experts representing Vermillion, a multivariate diagnostics company focused on gynecologic cancers and women’s health, presented on Aspira Labs, its new CLIA-certified reference laboratory. Aspira Labs provides expert diagnostic services, including OVA1 and Longitudinal CA 125 testing, which support clinical decision-making and personalized treatment plans.

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Hematology analyzers, 9/14

September 2014—Sysmex America displayed four new products at its booth. The DI-60 Integrated Slide Processing System provides automation of manual WBC differential process in a stand-alone configuration, offering a cell image analyzer for any type of laboratory or budget.

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Reagents, antibodies, and antigens, 9/14

September 2014—The Binding Site announced an enhancement to its Rheumatoid Factor/Immunoglobulin-G Absorbent Reagent specifically designed for use in conjunction with infectious disease immunodiagnostic procedures. The RF/IgG Absorbent Reagent can now be used to equally test and analyze serum and plasma samples without compromising test results.

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Enterprise-class LIS, 9/14

September 2014—Orchard Software has introduced Orchard Sequoia, a laboratory information system for the enterprise-wide lab. Sequoia is “designed to be scalable and to address the needs of the largest clients,” says Rob Bush, president of Orchard Software. The product’s three-tier design accommodates the needs of high-volume laboratories across multiple locations and departments, including clinical, molecular, anatomic pathology, and microbiology.

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Biofortuna expands its freeze-dried production capacity, 9/14

September 2014—Biofortuna announced the expansion of its freeze-dried production service. Biofortuna invested in a new, state-of-the-art freeze-drier and additional climate-control units to meet the increased demands of companies that are outsourcing their freeze-dried production of diagnostic kits. The additional freeze-drier and infrastructure almost doubles the company’s production capacity.

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Environmentally friendly immunoassay reagents, 9/14

September 2014—Eco-Tek products by Kem-En-Tec, distributed in the U.S. by Rainbow Scientific, reduce the environmental impact of ELISA, blotting, or immunohistochemistry applications by eliminating biological and chemical hazards commonly found in diagnostic assay components, including bovine serum albumin, sodium azide, and harmful organic solvents, without compromising quality, reliability, or stability.

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White blood cell syringe filter, 9/14

September 2014—Pall Life Sciences’ Acrodisc WBC premium syringe filter is a filtration device designed specifically for use in the capture and recovery of leukocytes and the separation of red blood cells. The Acrodisc WBC filter contains the company’s patented Leukosorb media.

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Compact Max celebration, 9/14

September 2014—Diagnostica Stago celebrated the success of its newest instrument line with the competitive conversion placement of its 100th Compact Max in six months. The Compact Max, an intelligent, user-friendly platform for coagulation testing, is the first of the Max line of instruments that will be rolling out to laboratories worldwide over the next couple of years.

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Surface coating for diagnostic testing, 9/14

September 2014—The Mix&Go product is a proprietary surface coating for use in diagnostic testing from Anteo Diagnostics. Mix&Go incorporates a type of molecular Velcro that provides a novel approach for attaching fragile proteins to synthetic surfaces distinct to the traditional methods, enabling the development of sensitive and affordable diagnostics.

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Calprotectin assay, 8/14

August 2014—Inova Diagnostics announced the global launch of Quanta Lite Calprotectin, an FDA-cleared, quantitative ELISA that detects calprotectin levels, aids in the diagnosis of inflammatory bowel disease, and can also help differentiate, in conjunction with other laboratory and clinical findings, IBD from irritable bowel syndrome.

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Cancer gene panels, 8/14

August 2014—Qiagen launched 14 GeneRead DNAseq V2 gene panels targeting a range of cancer-related genes or gene regions, including focused panels, each targeting 8–25 genes, disease-specific panels for 40–50 genes, and comprehensive panels for as many as 160 genes.

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Nuclea, CRL to offer diagnostic assays, 8/14

August 2014—Nuclea Biotechnologies has partnered with Clinical Reference Laboratory for initial CLIA assay validation and subsequent laboratory processing in support of three of Nuclea’s key tests. Initial efforts will focus on Nuclea’s flagship assay, the Oncogene Science 159 gene-based prostate cancer monitoring test, and its Nuvera breast cancer assay.

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Cassette printer, 8/14

August 2014—Primera’s Signature Cassette Printer prints high-resolution text and graphics along with linear and 2D bar codes directly onto tissue cassettes. The printer has four cassette hoppers, each holding 40 cassettes, and can print up to 11 cassettes per minute.

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Expanded RUO capabilities for MALDI Biotyper, 8/14

August 2014—MALDI Biotyper systems can be configured for further functionality by adding new or expanded research-use only software modules or hardware accessories.

The MBT Explorer module provides multiple bioinformatics approaches for spectra comparison, statistical data interpretation, and the generation of customer-specific reference library entries (main spectra) of strains of special interest. Such sub-libraries can be exported and re-imported in networks of collaborating labs.

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Refrigerated benchtop centrifuge, 8/14

August 2014—Thermo Fisher Scientific’s refrigerated small benchtop centrifuges separate samples in a compact footprint and run a wide range of applications. The refrigeration system provides a temperature range of -10°C to -40°C and can maintain temperatures when the chamber is not in use.

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Proteinase–3 (cANCA) native autoantigen, 8/14

August 2014—A Proteinase–3 (cANCA) native autoantigen for the in vitro diagnostics market is available from The Binding Site. Expressly designed for use as an integral component in solid-phase, ELISA-based immunoassay test procedures, the Proteinase–3 (cANCA) native autoantigen is for clinical and life-science researchers, medical laboratory professionals, and manufacturers of in vitro diagnostic immunoassay kits and tests for autoimmune conditions.

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Electronic pipettes, 8/14

August 2014—E1-ClipTip electronic pipettes from Thermo Fisher Scientific are designed to maintain precise sample volumes on every channel with fewer repetitions and reproducible results for multiple application types. The ClipTip technology, electronic tip ejection, intuitive personalized user interface, and adjustable tip spacing for sample transfers make the E1-ClipTip pipette an optimal solution for complex and demanding protocols.

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CLSI guidelines, 8/14

August 2014—The Clinical and Laboratory Standards Institute published H52-A2—Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition. This standard addresses the diagnostic red blood cell assays performed as fluorescence-based assays on a flow cytometry platform, including testing procedures for fetomaternal hemorrhage detection, paroxysmal nocturnal hematuria screening, membrane defect anemia testing for hereditary spherocytosis, and nucleated RBC counting. Caveats of interpretation and points of validation and quality control are also discussed.

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Flow cytometry controls, 8/14

August 2014—Streck added markers to CD-Chex CD117 Plus, a commercially available positive procedural control for CD117, and now CD25 and CD71. CD-Chex 117 Plus eliminates the need for laboratories to hold and validate patient samples to use as a control for CD117, CD25, and CD71.

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Calreticulin biomarker, 8/14

August 2014—Qiagen acquired an exclusive worldwide license to the biomarker calreticulin. Qiagen licensed the technology from CeMM Vienna, the research center for molecular medicine of the Austrian Academy of Sciences. Qiagen plans to develop a molecular diagnostic test for the CALR mutations to offer patients a clearer prognostic profile and to guide disease management.

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Xifin forms medical advisory board, 8/14

July 2014—Xifin, the financial cloud computing company for diagnostic service providers, formed a medical advisory board that will share its extensive expertise in pathology operations and workflow, lab automation, regulatory requirements, clinician needs, and pathology informatics important to the company’s product development and strategic initiatives.

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HIV-1 p24 sample kit, 8/14

July 2014—Meridian Life Science now has a sampling kit with HIV-1 p24 reagents for developing sensitive and specific HIV-1 p24 sandwich immunoassays. The kit includes a 0.25-mg vial of capture antibody, MAb to HIV-1 p24; a 0.25-mg vial of detection antibody, MAb to HIV-1 p24; and a 0.25-mg vial of recombinant HIV-1 p24 antigen (strain HxB2) expressed in Pichia pastoris. ...

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Automated order processing, 7/14

July 2014—To accommodate growing order volumes, BioMérieux has integrated Esker’s cloud-based order processing automation solution within its SAP environment for electronic order management. Esker’s intelligent data capture technology accurately extracts order information while automated workflow routes the orders to the appropriate customer service representative.

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Dako and Merck to collaborate, 7/14

July 2014—Dako and Merck & Co. will collaborate to develop a companion diagnostic test for the analysis of the potential tumor biomarker PD-L1 to aid in the treatment of cancer. The companion diagnostic test coming out of this collaboration will be evaluated as part of the clinical development program from Merck’s investigational anti-PD-1 antibody being studied for the treatment of cancer.

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Molecular-based MDRO test, 7/14

July 2014—OpGen launched a molecular-based test that can identify patients at risk for harboring serious disease-causing, antibiotic-resistant microbes, the Acuitas MDRO Gene Test. The test uses DNA amplification and detection technology to detect as many as seven genes from one patient sample—genes associated with deadly bacteria, including carbapenem-resistant enterobacteriaceae containing KPC, NDM-1, and OXA-48 genes—within 24 hours.

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Health Canada approves Roche’s HPV test, 7/14

July 2014—Health Canada approved Roche’s Cobas 4800 HPV Test for use as a first-line primary screening test for cervical cancer in women 25 and older. Roche also launched the fully automated CINtec Plus test to improve the detection and early intervention of precancerous cervical disease. The Health Canada–approved CINtec Plus cytology test helps identify women with high-grade precancerous cervical lesions who need immediate colposcopy.

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Vitamin D linearity and control kits, 7/14

July 2014—Audit MicroControls added ready-to-use vitamin D linearity and control kits to its line of calibration verification/linearity and daily quality control products. These liquid, human serum–based products are intended for use with quantitative assays on clinical laboratory analyzers, simulating human patient serum samples. The Linearity LQ Vitamin D (universal) and Linearity LQ Vitamin D Roche both have five levels that demonstrate a linear relationship to each other when assayed for vitamin D, have a shelf life of two years, and an open-vial stability of 14 days when stored at 2°–8°C.

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Myriad presents Prolaris data at AUA, 7/14

July 2014—Myriad Genetics presented new data from a clinical validation study of Prolaris at the American Urological Association annual meeting in May. A key finding was that the Prolaris molecular diagnostic test accurately differentiated newly diagnosed patients who were likely to die from prostate cancer within 10 years from those with lower-risk disease. The goal was to validate the Prolaris test score in 761 conservatively managed prostate cancer patients diagnosed by needle biopsy.

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FDA clearance for parathyroid hormone assay, 7/14

July 2014—DiaSorin received FDA clearance for its Liaison N-Tact PTH Gen II immunoassay, intended for the quantitative determination of intact human parathyroid hormone in human serum and plasma samples. The kit contains 200 tests and has an open-kit shelf life of 8 weeks, meeting the needs of small- and large-volume laboratories. It also has low cross-reactivity to the 7-84 and other inactive fragments, supporting conservative patient management.

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HIV-1 p24 sample kit, 7/14

July 2014—Meridian Life Science now has a sampling kit with HIV-1 p24 reagents for developing sensitive and specific HIV-1 p24 sandwich immunoassays. The kit includes a 0.25-mg vial of capture antibody, MAb to HIV-1 p24; a 0.25-mg vial of detection antibody, MAb to HIV-1 p24; and a 0.25-mg vial of recombinant HIV-1 p24 antigen (strain HxB2) expressed in Pichia pastoris

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C. diff kit earns clearance, 7/14

July 2014—Qiagen’s artus C. difficile QS-RGQ MDx Kit received FDA clearance, and its QIAsymphony RGQ MDx system was granted 510(k) regulatory clearance by the FDA. In addition, the artus VanR QS-RGQ MDx Kit for detection of vancomycin-resistant bacteria, available in Europe, is expected to be submitted to the FDA this year. The artus MRSA QS-RGQ MDx Kit for methicillin-resistant Staphylococcus aureus is expected to be launched in Europe this year and submitted to the FDA in the third quarter of 2014. Test kits for diagnosis of group B streptococcus and herpes simplex virus (HSV 1/2) are in the advanced stages of development.

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Women’s health diagnostics lab, 7/14

July 2014—Vermillion launched Aspira Labs, which will specialize in using a biomarker-based diagnostic algorithm to inform clinical decision-making and advance personalized treatment plans in the management of gynecologic cancers. The lab, based in Austin, Tex., will also serve as an education and resource hub for health care professionals and women facing surgery for ovarian masses that are potentially cancerous and other related gynecologic conditions.

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Horizon licenses CRISPR gene-editing technology, 7/14

July 2014—Horizon Discovery entered into a nonexclusive license agreement with the Broad Institute to access intellectual property related to the CRISPR/Cas9 gene-editing system. Under the terms of the agreement, Horizon has rights to use the technology commercially for applications including development of research tools and reagents.

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Leica Microsystems opens Experience Lab, 7/14

July 2014—Leica Microsystems opened an Experience Lab in its Tokyo headquarters. The laboratory is dedicated to product demonstrations of Leica microscope systems and workshops. Additionally, it serves as a showroom for microscope users who wish to get to know the instruments and accessories, such as cameras, illumination, and software. Users can bring their own samples to observe with the systems and can take advantage of a sample preparation service for industrial samples to be observed and analyzed on site.

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High-performance centrifuge system, 7/14

July 2014—Designed to improve productivity and ensure sample safety and integrity, the Thermo Scientific Sorvall RC BIOS 10 centrifuge system accommodates a range of cell culture and bioprocessing applications. The company’s Fiberlite F5-10x1000 LEX carbon fiber rotor spins up to 10 one-liter Nalgene centrifuge bottles in a single run. The system’s large capacity and design suits numerous applications, including bacterial and mammalian cell pelleting, pelleting of cell cultures from fermentation tanks, large microbial cultures, biologics and vaccine production, clarifying broths, and harvesting cell and tissue cultures.

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Automated ALK FISH scanning microscope, 7/14

July 2014—BioView announced that the FDA cleared for marketing its automated scanning microscope and image analysis system, the Duet, to qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization in formalin-fixed, paraffin-embedded non-small cell lung cancer tissue specimens, probed with the Abbott Vysis ALK Break Apart FISH Probe Kit.

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Preanalytical sample processing instrument, 7/14

July 2014—Hologic’s Tomcat instrument performs a full range of sample processing activities for liquid-based cytology samples, from decapping and capping of sample tubes to vortexing, aliquoting, incubating, and racking of each sample. The fully automated instrument provides positive bar-code matching for each sample as well as reagent addition if desired. By eliminating repetitive manual steps, the instrument enhances workflow efficiency and reduces hands-on time, which minimizes the risk of cross-contamination.

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Point-of-care analyzer, 7/14

July 2014—Designed specifically for point-of-care testing, Radiometer’s ABL90 Flex is a compact, acute care analyzer with optional wireless capability, making it possible to place it near the patient and close to the OR, ED, ICU, or a step-down unit.

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Software package for data acquisition in cytometry, 7/14

July 2014—Kaluza for Gallios software for the Beckman Coulter Gallios cytometer uses data acquisition tools to increase efficiency and performance in the cell characterization and analysis workflow of core research laboratories. The software features a guided, intuitive drag-and-drop interface and facilitates creation of the right setup for accurate plot output. Visual management tools enable tracking of instrument function and experiment progress. Voltage and compensation can be quickly changed, and unlimited “undo” aids new users.

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Copan and MetaSystems’ global partnership, 7/14

July 2014—Copan and MetaSystems signed a global and exclusive agreement for the integration of an automatic microscopy slide scanning system, provided by MetaSystems, with WASPLab. The partnership provides Copan customers a fully automated system for the acquisition of microscopy images of Gram slides (under the brand Metafer) integrated with the WASPLab environment.

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Microfluidic-based clinical immunoanalyzer, 7/14

July 2014—Wako Life Sciences’ µTasWako i30 is available for the serum biomarkers lectin-reactive alpha-fetoprotein (AFP-L3) and des-gamma-carboxy prothrombin (DCP) tests, which are intended for in vitro diagnostic use to help in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma in conjunction with other laboratory findings, imaging studies, and clinical assessment.

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Blood culture identification panel, 7/14

July 2014—The FilmArray BCID Panel M235 from Maine Molecular Quality Controls is for in vitro use as a quality control to monitor the detection and identification of 24 pathogens and three antibiotic-resistance genes associated with bloodstream infections when tested by the FilmArray Blood Culture Identification Panel. The kit contains 12 tubes, 100 µL each, of synthetic DNA suspended in a noninfectious solution of buffers, preservatives, and stabilizers and should be stored at 2°–8°C.

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New molecular methods standards, 7/14

July 2014—The Clinical and Laboratory Standards Institute released Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition (MM09-A2) and published a new document, Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline (MM22-A). 


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DeNovo Sciences publishes on CTC technology, 7/14

July 2014—DeNovo Sciences published “A novel microchannel-based device to capture and analyze circulating tumor cells (CTCs) of breast cancer.” DeNovo’s scientific team explored microfluidic capture techniques for isolating CTCs, which resulted in the development of proprietary technology to accomplish rare cell capture and analysis.

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Handheld label printer, 7/14

July 2014—Combining a tough exterior with smart printing capabilities, Brady’s BMP21-LAB handheld printer is designed for labeling slides, straws, dishware, bottles, vials, and tubes. The printer’s drop, lock, and print technology enables users to insert the label cartridge and start printing, with no setup required. The vial label shortcut key automatically cuts labels according to vial and tube sizes. Once the label is printed and cut, the grabber feature prevents it from falling to the ground.

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Automated slide staining system, 7/14

July 2014—Biocare Medical expanded its automated instrumentation offering with the Oncore Automated Slide Staining System. The Oncore is a compact benchtop instrument that performs both immunohistochemistry and in situ hybridization tests on formalin-fixed, paraffin-embedded tissues.

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Beckman Coulter to acquire Xitogen, 6/14

June 2014—Beckman Coulter entered into an agreement to acquire Xitogen Technologies together with Cytojene Corp. Xitogen, a flow cytometer developer based in Suzhou and Dalian, China, will provide Beckman Coulter Life Sciences with an operational base in the China market, and the facilities in Suzhou and Dalian will function as research and development and manufacturing centers.

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Influenza type A and B kit, 6/14

June 2014—The Poly stat Flu A & B kit from Polymedco is an in vitro, rapid qualitative test that detects influenza type A and B, including numerous strains of H1N1, directly from a nasal or nasopharyngeal swab, as well as nasopharyngeal aspirate/wash specimens.

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Leica joins GHX Exchange, 6/14

June 2014—Leica Biosystems joined the GHX electronic trading exchange for U.S. customers. The GHX Exchange enables provider organizations to send their electronic data interchange (EDI) transactions through a single connection as opposed to multiple point-to-point EDI connections, thus allowing Leica’s customers to view their transactions and address discrepancies in real time.

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Software enhancements, 6/14

June 2014—AccuCore released AccuPathology 5.0, which includes enhancements in direct support of CoPath, PowerPath, Millennium, and AP Easy LIS. The Lab Equipment module now has optional wireless wi-fi logging to eliminate manual recording of temperatures and humidity levels and includes alerts.

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CellaVision expands product portfolio, 6/14

June 2014—CellaVision launched two new products, the CellaVision DM9600 (a replacement for CellaVision DM96), and CellaVision Advanced RBC Application, a software application for advanced analysis of red blood cells, both for use in clinical laboratories that handle large testing volumes and require a large capacity.

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Randox FDA-cleared controls, 6/14

June 2014—Randox’s Acusera HbA1c received FDA clearance. It is a 100 percent human whole blood, lyophilized control with assayed values provided for high-performance liquid chromatography and a wide range of clinical chemistry analyzers. When reconstituted the control remains stable for four weeks at 2°–8°C. The control is available in levels 1 and 2, and a calibrator is also available.

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POC devices, 6/14

June 2014—The Minivette POC testing devices from Sarstedt are for the collection, transfer, and subsequent dispensing of small capillary blood samples for point-of-care tests. Blood is collected via capillary action into the collection capillary, the sample is held securely during transfer, and then it is dispensed onto the test field or into a micro tube with a slight push of the opposing integral piston.

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High-performance centrifuge, 6/14

June 2014—Avanti JXN-26 centrifuges from Beckman Coulter have an intuitive interface and advanced data management features, including the ability to track and manage centrifuge runs remotely using Mobile­Fuge, a mobile application for Apple iOS or Android devices.

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In situ hybridization adapter, 6/14

June 2014—Techne added an in situ hybridization adapter to its Prime range of thermal cyclers. By inserting the adapter, a 96-well thermal cycler is converted to an in situ hybridization instrument that can accommodate up to four standard-size microscope slides with ±0.25˚C block uniformity.

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Reusable sharps container, 5/14

December 2013—Rehrig Pacific’s SharpsTank reusable sharps container model TS has received FDA 510(k) clearance as a class II medical device. The SharpsTank model TS is a 4.9-gallon reusable container with an integrated hinged lid, restrictive mail chute, and flusher insert. The container is supplied to the customer fully assembled.

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Multilabel slide scanner, 5/14

May 2014—PerkinElmer launched the Lamina multilabel slide scanner at the USCAP 2014 Annual Meeting. The scanner is a high-throughput imaging system for research pathologists in a larger research facility to study protein expression and the relationships between disease markers in formalin-fixed, paraffin-embedded tissue sections.

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ConfirmMDx case study, 5/14

May 2014—Cancer test was used as part of a multidisciplinary approach to confirm prostate cancer diagnosis using a technique called transperineal mapping biopsy. The cancer lesions found using this method were not detected by five conventional biopsies.

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Data-management software upgrade, 5/14

May 2014—Siemens Healthcare released a software upgrade for the RAPIDComm Data Management System (V5.0), an informatics solution to centrally manage Siemens’ in vitro diagnostics analyzers and operators at the point of care. The upgrade includes the RAPIDComm Web Application, which allows POC coordinators to view the status of their POC instruments and troubleshoot from a handheld device.

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Siemens, NKF enter strategic alliance, 5/14

May 2014—Siemens Healthcare and the National Kidney Foundation entered into a strategic alliance to increase awareness of the importance of albumin-to-creatinine ratio testing in high-risk individuals, with the goal of improving diagnosis and identifying kidney disease early in its course. Siemens and NKF will also help put the new clinical recommendations into practice.

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QML for connectivity, 5/14

May 2014—Telcor released a software driver for the Pathfast cardiac biomarker analyzer that allows the company’s QML to automatically interface results from the analyzer to a laboratory information system and electronic medical record system.

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Bone marrow tissue stain, 5/14

May 2014—Dako added the Jenner-Wright Giemsa stain to its Artisan Link portfolio of automated stains. The stain is designed to provide clear differentiation and detail of the hematopoietic cells in bone marrow tissue samples for the diagnosis of cancer, aplastic anemia, and myelofibrosis.

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Reference standards, 5/14

May 2014—Cerilliant introduced 14 Snap-N-Spike solutions of phenethylamines, a class of drugs. These certified reference materials are suitable for numerous applications in GC/MS or LC-MS/MS testing, from urine drug monitoring and forensic testing to clinical toxicology analysis.

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Coulter Counter, 5/14

May 2014—The Multisizer 4e Coulter Counter from Beckman Coulter Life Sciences has a 10-µm aperture for obtaining accurate count, size, and mass distribution for particles and cells ranging from 0.2 to 1,600 µm. Digital pulse processing provides high-resolution analysis in up to 400 channels.

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WaferGen acquisition, 5/14

May 2014—WaferGen Bio-systems acquired the NGS library preparation business from IntegenX. Pursuant to the purchase agreement, the company acquired substantially all of the assets of IntegenX’s product line used in connection with developing, manufacturing, marketing, and selling instruments and reagents relating to library preparation for NGS.

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CLSI QMS15 guideline, 5/14

May 2014—The Clinical and Laboratory Standards Institute released a new quality management systems standard: QMS15-A—Laboratory Internal Audit Program; Approved Guideline. The document provides guidance on how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement. CLSI, 610-688-0100

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Automated pipetting systems, 4/14

April 2014—Eppendorf North America added five models to its epMotion range of automated pipetting systems. The epMotion 5075 system uses Eppendorf’s epBlue software and an intuitive software assistant concept that can be easily programmed and requires only initial training for new users.

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New CLSI editions: M100-S24, eM100, 4/14

April 2014—The Clinical and Laboratory Standards Institute released a new edition of its document M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement, which provides updated tables for the CLSI antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8.

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Middleware user satisfaction, 4/14

April 2014—Siemens Healthcare Diagnostics’ CentraLink Data Management System achieved the highest rating for overall user satisfaction, according to the Middleware Market Monitor, a report published by Information Dynamics. The report reviews the current use of middleware solutions in the main hospital clinical laboratory and tracks changes in product usage or applications.

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Product catalog, 4/14

March 2014—Semrock released its 2014 Master Catalog, which has a concise layout of product information and includes new products, such as assorted single-band bandpass edge filters and dichroics and the BrightLine full-multiband laser filter set optimized for 405, 488, 561, and 635 nm laser sources.

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Colorectal cancer screening kits, 4/14

April 2014—EntroGen expanded its line of colorectal cancer screening products to include the EntroGen K-Ras and N-Ras Mutation Analysis kits. The kits are updated to include coverage for exon 2, 3, and 4 mutations in both genes. The company obtained a CE IVD mark for these products.

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‘Universal’ NGS solutions, 4/14

April 2014—Qiagen announced the launch plans of products designed to reduce the challenges of bottlenecks in next-generation sequencing: sample preparation and bioinformatics. The products add to Qiagen’s portfolio of solutions designed to run with any NGS platform.

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Horizon-Haplogen agreement, 4/14

April 2014—Horizon Discovery signed a worldwide distribution agreement with Haplogen in which customers can access, directly from Horizon, Haplogen’s Haploid Gene Trap Mutant Collection of isogenic human cell lines deficient for the expression of single genes. This is the first time Horizon will distribute another company’s products.

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Artus C. difficile kit, 4/14

April 2014—IMDx’s artus C. difficile QS-RGQ kit received CE marking for use with QIAsymphony SP/AS and Rotor-Gene Q instruments. Concurrently, in December 2013, a Premarket Notification 510(k) for the test was submitted to the FDA for review.

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Audit Web site, 4/14

April 2014—Audit MicroControls launched a new Web site, adding online ordering, access to Auditor QC, peer review data retrieval, and search functions by instrument, analyte, or indication. It also offers information about quality control products, calibration verification/linearity products, Audit Ship, and Audit Faxback.

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Troponin I POC test

April 2014—Trinity Biotech’s Meritas Troponin I (TnI) point-of-care test obtained CE marking. The test enables accurate triage and intervention for emergency department patients with possible myocardial infarction; results are available in 15 minutes.

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Partners: UCSF, Quest, 4/14

April 2014—UC San Francisco and Quest Diagnostics formed a collaboration to accelerate the translation of biomedical research into advanced diagnostics in the field of precision medicine for improved patient care, treatment, and outcomes.

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Anatomic pathology reference laboratory, 4/14

April 2014—PAML and CellNetix launched a joint venture anatomic pathology reference laboratory separately branded as Symbiodx. A major focus of this venture will be on molecular oncology with a broad offering of molecular tests, including next-generation sequencing, IHC, flow cytometry, and cytogenetics.

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IHC guidebook, 3/14

March 2014—The sixth edition of The Educational Guidebook: IHC Staining Methods, published by Dako, is now available. The guidebook is used as a teaching and learning tool worldwide and serves as a reference for ensuring correct staining processes within the lab. Several experts within the field of IHC wrote this new edition and Clive R. Taylor, MD, is the editor.

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Qiagen and Exosome expand partnership, 3/14

March 2014—Qiagen expanded its strategic partnership with Exosome Diagnostics to develop a noninvasive molecular in vitro diagnostic. The novel blood-based diagnostic detects certain mutations of an undisclosed gene associated with non-small cell lung cancer and other malignancies and has the potential to be paired with several new anticancer therapeutics.

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FDA clears CytoScan Dx, 3/14

March 2014—Affymetrix received FDA 510(k) clearance to market its CytoScan Dx assay, intended for the postnatal detection of DNA copy number variants in patients referred for chromosomal testing. Cyto­Scan Dx is designed to help diagnose children’s developmental and intellectual disabilities more comprehensively by enabling a high-resolution, genome-wide analysis of genetic aberrations.

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SureFISH probes, 3/14

March 2014—Agilent Technologies introduced SureFISH ALK, ROS1, and RET break-apart translocation probes, expanding its offering of oligonucleotide-based fluorescent in situ hybridization products. The probes are repeat-free, able to target specific sequences of interest, and use high-fidelity oligos designed in silico.

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HPLC analyzer, 3/14

March 2014—The Tosoh G8 (Tosoh Automated Glycohemoglobin Analyzer HLC-723G8) has been cleared by the FDA as the first high-performance liquid chromatography (HPLC) instrument for use as an aid in diagnosing diabetes and identifying patients who may be at risk for developing diabetes. The Tosoh G8 was initially cleared in 2008 as a diabetes monitoring device; the intended use has now been expanded to screening as well.

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O&P fixative, 3/14

March 2014—Medical Chemical’s Total-Fix stool fixative for ova and parasites is now patented. Total-Fix does not contain any mercury, formaldehyde, or PVA. It is a multi-use, single-vial system that preserves stool specimens for staining (Trichrome/iron hematoxylin), concentration, Giardia and Cryptosporidium antigens, and fluorescent assays. Total-Fix also preserves molecular material in stool for molecular (real PCR) assays.

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Waters expands UNIFI solutions, 3/14

March 2014—Waters Corp. announced three UNIFI Scientific Information System solutions: Waters Glycan Application Solution with UNIFI, Forensic Toxicology Screening Application Solution with UNIFI, and Natural Products Application Solution with UNIFI. Each application features a proprietary, comprehensive library of relevant molecules.

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Grp78/BiP ELISA kit, 3/14

March 2014—Enzo Life Sciences’ high-sensitivity Grp78/BiP ELISA kit is an endoplasmic reticulum-specific homologue of Hsp70, serving as a critical stress-sensing chaperone and regulator of the unfolded protein response (UPR). Grp78 helps fold misfolded proteins, prevent protein aggregation, and regulate protein degradation, synthesis, transportation, and oligomerization.

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Clarient modifies SeqWright, 3/14

March 2014—Clarient Diagnostic Services, a GE Healthcare company, has modified its facility in Houston to support a full range of clinical diagnostic testing for cancer. The facility, which operates under the name SeqWright Genomic Services, is a CLIA-certified lab offering nucleic acid sequencing and genomics services.

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Molecular standards, 3/14

March 2014—Helix Elite is the first molecular product line from Microbiologics. It includes 13 molecular standards—intended to facilitate the development, validation, and monitoring of molecular assays—for microorganisms that are difficult to grow or cannot be cultured, such as Cryptosporidium and norovirus.

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Phlebotomy seminars, 3/14

March 2014—The Center for Phlebotomy Education will conduct intensive three-day seminars in Indianapolis and San Francisco for those who train or manage phlebotomists. The event will provide strategies to help attendees reduce expenses by cultivating satisfied, long-term employees; cut costs through process improvement; nurture professionalism and responsibility among specimen-collection personnel; implement different learning styles to maximize teaching; and mentor students and new staff.

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Interpretation and reporting solution, 3/14

March 2014—Qiagen last year enrolled molecular diagnostics laboratories in an early access program to complete the development of a Web-based solution to deliver faster, easier-to-use, and high-confidence clinical interpretation and reporting of observed gene variants in data from NGS-based tests.

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Linearity FD D-Dimer PathFast Immunoanalyzer, 3/14

March 2014—Audit MicroControls added the Linearity FD D-Dimer PathFast Immunoanalyzer, five levels, to its line of calibration verification/linearity products. It is intended to simulate human patient serum samples for the purpose of determining linearity, calibration verification, and verification of reportable range for D-dimer.

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Software 2.0 for Quantum, 3/14

March 2014—Terumo BCT released Quantum Software 2.0, updated and enhanced software for the Quantum Cell Expansion System, as part of its ongoing goal to aid cell-therapy companies and research organizations in current Good Manufacturing Practices and in compliance with part 11 of the Code of Federal Regulations.

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DNA dye system, 3/14

March 2014—Promega launched the QuantiFluor One dsDNA System, a sensitive, dsDNA-specific fluorescent dye for use in research and clinical workflows. The dye system is integrated into the Promega Quantus Fluorometer and GloMax detection instruments but is compatible with any fluorometer capable of measuring the appropriate fluorescence excitation and emission spectra.

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Tissue, ID micro arrays, 3/14

March 2014—Bio SB launched the Normal Human Tissue Micro Array and the Infectious Disease Cell Line Micro Array. The NH-TMA arrays are available in 11- or 23-core configurations, allowing testing of multiple tissues on one slide, and are validated for use with more than 100 antibodies in immunohistochemistry.

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ASI, Biocare partnership, 2/14

February 2014—Applied Spectral Imaging (ASI) and Biocare Medical signed a partnership agreement in which Biocare will distribute ASI’s IHC and CISH imaging and analysis solution, GenASIs Pathology, in the United States. The agreement brings to cytopathology and anatomic pathology laboratories a fully integrated solution that improves quality while providing workflow efficiencies.

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DNA enrichment kits, 2/14

February 2014—EKF Molecular Diagnostics launched four PointMan DNA enrichment kits for the research-use-only market, with planned diagnostic registration in Europe in 2014. As a real-time PCR technology, PointMan provides reliable and extremely sensitive detection of cancer mutations by amplifying the target sequence of interest in a background of wild-type genes. Using this technology, the enrichment kits are an ideal research tool for understanding biomarker and drug response.

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HER2 companion diagnostic, 2/14

February 2014—Ventana Medical Systems’ HER2/neu (4B5) Rabbit Monoclonal Primary Antibody assay is a companion diagnostic for detecting HER2 protein expression in patients who, in countries where the drugs are approved, may be appropriate candidates for Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine).

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OraSure, Thermo Fisher agreement, 2/14

February 2014—OraSure Technologies has reached an agreement with Thermo Fisher Scientific to develop and supply up to 12 homogenous, fully automated oral fluid drugs-of-abuse assays to be used with OraSure’s new Intercept oral fluid specimen collection device. OraSure will have the right to purchase and resell the assays in the U.S. and certain foreign countries, subject to receipt of applicable regulatory approvals.

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Hantavirus monoclonal antibodies, 2/14

February 2014—ViroStat has developed three new monoclonal antibodies to the nucleocapsid protein (N) of hantavirus. One of these recognizes all viruses tested (six) while the other two recognize four viral species. These new antibodies are useful tools to further the research of this viral genus.

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qPCR master mix, 2/14

February 2014—Empirical Bioscience, a company that produces high-grade PCR reagents and enzymes, has introduced rEVAlution qPCR Master Mix, an environmentally safe, ready-to-use hot start qPCR mixture specifically formulated with high-quality components to offer superior safety, speed, and signaling capabilities.

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PCR-free DNA library kit, 2/14

February 2014—Swift Biosciences announced the launch of the Accel-NGS PCR-free DNA Library Kit for Illumina next-generation sequencing systems. The kit is designed to bring low input requirement, PCR-free capability, and fast, easy workflow to the Illumina platform.

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Hamilton Scientific products installation, 2/14

February 2014—Hamilton Scientific recently completed installation of 60 fume hoods and 120 laboratory benches in the 200,000-sq.-ft. lab space at the Wisconsin Energy Institute and Consolidated Forensic Lab. The laboratory workstation design was developed in response to the customer’s request for ease of utility access while simultaneously allowing for movable laboratory benches.

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Enzo study could lead to clinical diagnostic for IPF, 2/14

February 2014—Enzo Biochem published a study in Modern Pathology that shows a strong association between idiopathic pulmonary fibrosis (IPF) and the presence of the herpesvirus saimiri virus, a virus native to squirrel monkeys. The breakthrough discovery of the IPF’s origin is expected to result in a clinical diagnostic that could lead to screening and diagnosis, and perhaps result in potential treatment, for this fatal disease.

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TissueMark software, 2/14

February 2014—TissueMark, developed by Belfast-based digital pathology specialists PathXL, was launched at the 2013 annual meeting of the Association for Molecular Pathology. It analyzes the structural patterns in tissue samples and marks the boundaries of potentially cancerous sections for more detailed analysis.

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Automated system for NGS library prep, 2/14

February 2014—To meet the needs of today’s next-generation sequencing projects, Aurora Biomed offers the VERSA NGS Library Prep Workstation for high throughput preparation of sample libraries. VERSA enables automated processing of up to 96 libraries in parallel with the high precision needed for quality results.

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KIM-1 ELISA kit, 2/14

February 2014—Enzo Life Sciences now offers a KIM-1 ELISA kit. Kidney injury marker 1 (KIM-1) is the most highly upregulated protein in the proximal tubule of the injured kidney and is detectable in the urine within six hours of injury. KIM-1 has been identified as an early diagnostic and prognostic marker of acute kidney injury resulting from illness, trauma, or nephrotoxicity, and with decreased kidney function and renal failure associated with chronic disorders such as diabetes and high blood pressure.

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Myriad Genetics/BioMarin research collaboration, 2/14

February 2014—Myriad Genetics announced a research collaboration with BioMarin that will use Myriad’s novel HRD (homologous recombination deficiency) test to identify tumor types that may be sensitive to BioMarin’s investigational product candidate, BMN-673. Specific terms of the deal, the second research collaboration between the partners, were not disclosed.

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Universal blocking oligos, 2/14

February 2014—Integrated DNA Technologies launched the latest addition to its portfolio of next-generation sequencing products, xGen Universal Blocking Oligos. By incorporating these oligos into target-capture experiments, users can decrease the complexity and increase the throughput of their target-capture experiment without degrading performance.

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Caris presents patient tumor profiling study, 2/14

February—Caris Life Sciences presented a study at the December 2013 CTCR-AACR San Antonio Breast Cancer Symposium on identifying potentially actionable therapeutic targets and clinical strategies for triple-negative breast cancer (TNBC). The biomarker data used for the study were obtained using the company’s tumor profiling service, Caris Molecular Intelligence.

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Verigene BC-GN test, 2/14

February 2014—Nanosphere received FDA clearance for its Verigene Gram-Negative Blood Culture (BC-GN) Test, an in vitro diagnostic test that determines resistance to commonly used antibiotics up to two to three days faster than conventional identification methods. Among the critical genetic markers of antibiotic resistance identified by Verigene BC-GN are five genes that can identify carbapenem-resistant Enterobacteriaceae.

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Test predicts response to cisplatin treatment, 2/14

February 2014—Myriad Genetics presented clinical data from a research study showing that its HRD (homologous recombination deficiency) test predicted platinum response in patients with triple-negative breast cancer (P=0.0003). The HRD score predicted, with a sensitivity of 100 percent, all of the patients who experienced a complete response after presurgical treatment with platinum. In addition, the results showed that the HRD score was generalizable across all breast cancer subtypes.

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General-purpose reagents, 2/14

February 2014—Life Technologies released general-purpose reagents (GPRs) for the development of molecular diagnostic assays based on qPCR and capillary electrophoresis (CE). GPR products are for laboratory use and come with a higher quality assurance than research-use-only products. For CE (for sequencing and fragment analysis), BigDye Terminator Cycle Sequencing Reagents provide the required components for cycle sequencing reactions in a premixed format. They are optimized for longer, higher-quality reads with uniform peak heights and optimal signal balance and are appropriate for a range of applications, including de novo sequencing and resequencing.

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Freezerworks Unlimited upgrade, 1/14

January 2014—Dataworks Development released an upgrade, version 6.0, to its Freezerworks Unlimited freezer inventory and sample management software program. Expanded configurability in version 6.0 is most notable with improvements and greater capabilities in screen design and layout, as well as in adapting the shipping processes to the workflow of the lab, biobank, and repository. The report writer has been redesigned to offer a more user-friendly interface for developing and printing reports, while adding flexibility for subtotaling and inventory counts. Users can also bar code any data field on a report for quick and accurate accessing of sample records and data.

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3D surgical microscopes, 1/14

January 2014—The first 3D surgical microscopes from Leica Microsystems with TrueVision 3D technology inside are now available to customers. By incorporating the digital smart 3D system inside select models of Leica’s surgical microscopes, Leica and TruVision have eliminated the need for a separate 3D cart.

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ICE COLD-PCR analysis presented, 1/14

January 2014—Transgenomic in October announced the results of a research collaboration with MD Anderson Cancer Center employing the company’s ICE COLD-PCR platform. This interim analysis demonstrates that in a high percentage of patients with advanced cancers, the same genetic mutations were detected in cell-free DNA present in the blood as were originally found in primary tumors. In a subset of patients followed over time, detection of mutations in cfDNA correlated with response to therapy or disease progression.

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RFID-enabled pipettes, 1/14

January 2014—Mettler Toledo has embedded radio- frequency identification tags in all of its premium Rainin air displacement pipettes, including its recently released E4 XLS electronic model. RFID tagging helps labs establish advanced calibration schedules through heightened pipette tracking.

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MPLN acquires MiSeqDx, 1/14

January 2014—Molecular Pathology Laboratory Network has acquired the Illumina MiSeqDx and will use the system to expand testing across all of its clinical laboratories, including its clinical trials group Geneuity Clinical Research Services. MPLN is a molecular reference laboratory specializing in oncology, women’s health, and clinical research services.

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