Marketplace Directory

February 2014—Bioresearch equipment provider Labnet International has announced the launch of an addition to Labnet’s constant temperature equipment line with the release of the new AccuTherm Microtube Shaking Incubator.

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.

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.

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.

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.

February 2014—BioMérieux is moving forward with its comprehensive automation solution for reference or centralized molecular biology laboratories and has selected Life Technologies’ 7500 instruments as its preferred thermocyclers.

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.

February 2014—Ventana Medical Systems received 510(k) clearance from the FDA for the Companion Algorithm ER (SP1) image-analysis algorithm used with the Ventana iScan Coreo scanner running Virtuoso software.

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.

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.

February 2014—Leica Biosystems announced a partnership with EyesFinder, a developer of visual search technology, to create decision support tools for pathologists.

February—NanoString Technologies announced the availability of the Prosigna Breast Cancer Prognostic Gene Signature Assay beginning in the first quarter of this year.

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.

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.

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.

January 2014—Air Science introduced its new Purair Eco line of energy-saving ductless fume hoods designed for chemical and particulate protection over a broad range of laboratory and industrial applications.

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.

January 2014—Spring Bioscience has added the Anti-PTEN (SP218) rabbit monoclonal immunohistochemistry antibody to its portfolio of antibodies for cancer research.

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.

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.

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.

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.

January 2014—Epigenomics announced the results from a clinical study that showed methylated SHOX2 to be a sensitive and specific biomarker for therapy monitoring and early detection of tumor response in lung cancer patients.

January 2014—Miraca Life Sciences (MLS) has acquired PLUS Diagnostics from Water Street Healthcare Partners. MLS provides diagnostic services in dermatology, gastroenterology, hematology, and urology.

January 2014—Ventana Medical Systems announced the positive findings of the Primary ASC-US LSIL Marker Study (PALMS) that have been published in The Journal of the National Cancer Institute (Ikenberg H, et al. 2013;105[20]:1550–1557).

January 2014—The Clinical and Laboratory Standards Institute has published a new document, “EP26-A–User Evaluation of Between-Reagent Lot Variation; Approved Guideline.”

January 2014—Diagnovus announced an addition to its Engauge cancer assay portfolio with the launch of the Engauge-cancer DLBCL Gene Panel, a genomic profile to aid physicians in tailoring treatment specifically for patients with diffuse large B-cell lymphoma.

January 2014—NanoString Technologies launched its nCounter Dx Analysis System for high-complexity, CLIA-certified laboratories. The nCounter Dx Analysis System is the only platform 510(k) cleared by the FDA to run the Prosigna Prognostic Breast Cancer Gene Signature Assay.

January 2014—Terumo BCT has been awarded a U.S. Department of Defense cost-share contract worth up to $29.9 million to advance the Mirasol system for the treatment of donated whole blood used in emergency transfusions to deployed military personnel.

January 2014—AION Laboratories, a division of PAML, has been established to provide a full spectrum of laboratory testing to age-management physicians and clinics across the country. AION’s aging-related tests use a single requisition to obtain a thorough laboratory assessment of each patient.

January 2014—Chembio Diagnostics received its first purchase order for its DPP HIV-Syphilis Assay from its distributor in Mexico. The DPP HIV-Syphilis Assay is based on the company’s patented Dual Path Platform (DPP), a point-of-care testing platform that is suited to multiplexing and that adds a syphilis biomarker to the company’s FDA-approved DPP HIV 1/2 test. The addition of this marker has resulted in a fingerstick whole blood test that can help reduce the transmission of HIV and syphilis from mother to child.

January 2014—ViroStat has released three new monoclonal antibodies that have broad reactivity with several rhinovirus types. These antibodies are reactive with the VP3 capsid protein and function in ELISA and IFA to detect these viruses. Data sheets for these antibodies are available from the company.

January 2014—Immunetics introduced an updated BacTx analyzer for use with its BacTx rapid test for bacteria in whole blood–derived and apheresis platelets. The analyzer offers automated interpretation, tracking, and documentation.

January 2014—Rainbow Scientific is offering advanced research products for human mesenchymal stem cell (hMSC) and human embryonic stem cell (hESC) culture from Biological Industries.

January 2014—Diagnostic BioSystems introduces a new chromogen to its color spectrum, PermaRed/HRP. This HRP-based substrate/chromogen system produces a sharp, contrasting brick red color.

January 2014—Royal Philips received 510(k) clearance from the FDA to market its HER2/neu IHC Digital Manual Read product in the U.S.

January 2014—With the recent acquisition by Nuclea Biotechnologies of Wilex (Oncogene Science), Nuclea will begin its foray into the GMP manufacturing and marketing of the FDA 510(k)-cleared HER2/neu blood test out of its facility in Cambridge, Mass. The test is available as an in vitro diagnostic in the U.S., Canada, and Europe (CE mark).

January 2014—Enzo Life Sciences has expanded its portfolio of drug discovery platforms with the introduction of the new Leading Light Sclerostin-LRP Screening System. Developed to meet the market need for a simple, sensitive biochemical screening assay for detection of sclerostin inhibitors (antagonists of the Wnt signaling pathway), this kit is a drug discovery tool for detecting small molecule inhibitors that disrupt the interaction between SOST and LRP5.

January 2014—The FDA has approved Hologic’s Aptima HPV 16 18/45 genotype assay for use on its fully automated Panther system. The Aptima HPV 16 18/45 genotype assay is performed using Hologic’s ThinPrep liquid cytology specimen and is intended to test specimens from women with Aptima HPV assay-positive results. The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates.

January 2014—Zenalux Biomedical has improved measurement reproducibility in its Zenascope system by adding pressure-sensing capability to its optical probe. The system now allows users to dial in a target pressure for each measurement via the user interface. After probe-to-tissue contact is made, the user interface monitors pressure feedback from the tip of the optical probe, facilitating data collection at the desired contact pressure.

January 2014—TriLink BioTechnologies has signed a licensing agreement with Biofortuna for use of its CleanAmp dNTPs in Biofortuna’s freeze-drying (lyophilized) contract development and production service.

January 2014—Abbott received FDA approval to expand the use of its RealTime HCV and RealTime HBV assay to run on its m2000 RealTime System. The new mPlus makes it possible for laboratories of any size to perform molecular diagnostic tests for infectious disease detection and therapy monitoring. It also enhances the Abbott m2000’s flexibility and makes molecular testing easier and more efficient.

January 2014—Ventana Medical Systems launched the Ventana Gram Staining Kit. Automated for use on the Ventana BenchMark Special Stains instrument, the kit aids pathologists in the most basic classification of bacteria into gram-positive and gram-negative bacteria in fixed tissue samples.

January 2014—Norwegian molecular diagnostics company Genetic Analysis has launched its GA-map IBS Dysbiosis Test. The DNA-based test makes it possible to effectively and routinely analyze the composition of the gut microbiota (bacteria profile) and any dysbiosis. The GA-map IBS Dysbiosis Test can be run in any molecular diagnostics laboratory. Target DNA is first isolated from patient stool samples. Then conserved ...

December 2013—Biosearch Technologies has acquired a majority stake in LightSpeed Genomics, a company developing an innovative optical-detection solution for the life science and diagnostics industry based on its proprietary Synthetic Aperture Optics (SAO) technology. Biosearch and LightSpeed are collaborators on the development of StellarVision, a next-generation gene-expression platform optimized to work seamlessly with Biosearch’s Stellaris RNA FISH assays to detect and quantify single-molecule RNA targets within individual cells.

December 2013—The Society for Laboratory Automation and Screening, an international community of more than 15,000 scientists, engineers, researchers, technologists, and others from academic, government, and commercial laboratories, announced the opening of a European office in Brussels, Belgium. SLAS’ European office becomes the society’s third on three continents, joining operations in Shanghai, China, and its global headquarters in the United States.

December 2013—Ventana Medical Systems has entered into an agreement with Incyte to collaborate on the development of companion diagnostic tests for Incyte’s oncology drug programs, beginning with the Incyte IDO1 inhibitor program.

December 2013—Mettler Toledo released the latest version of its interactive, Web-based Electrode ValueBox. This downloadable electrode identification and troubleshooting toolkit features a revised electronic sensor product guide to help Mettler Toledo customers choose the right electrode, saving time and enhancing accuracy when pH and other values are critical to experiment outcomes and product consistency.

December 2013—New Purair 5 ductless fume hoods from Air Science USA feature a high level of operator protection where routine work is being carried out. The units exceed OSHA, ANSI, and all relevant international standards, operate at low noise levels, and recirculate rather than exhaust expensive conditioned or heated air into the atmosphere.

December 2013—Mettler Toledo has released a series of free 30- to 45-minute video tutorials that provide insights into the topics of pipetting, weighing, pH determination, and thermal analysis.

December 2013—Sequenom has announced a certified service provider program for the technical certification of selected laboratories offering research services using the Sequenom research-use-only MassArray system. Certifications cover the major research applications of the MassArray system, including iPlex genotyping, OncoCarta somatic mutation profiling, ADME PGx, and EpiTyper DNA methylation analysis.

December 2013—The Clinical and Laboratory Standards Institute has released the latest version of a document addressing the design of measurement procedure comparisons using patient samples and subsequent data-analysis techniques for determining the bias between two in vitro diagnostic measurement procedures.

December 2013—The Centre of Excellence for the Prevention of Organ Failure (PROOF Centre) and HTG Molecular Diagnostics are collaborating to begin clinical validation of a biomarker blood test that will provide early indication of organ rejection in heart transplant patients and thereby allow doctors to better monitor and treat patients post-transplant. It is the first clinical validation study of this kind in Canada.

December 2013—Hamilton Robotics has launched a next-generation, liquid-handling platform that offers contact-free pipetting over a wide volume range. The Hamilton Vantage is space efficient, affordable, and can be remotely monitored by mobile devices. Its expandable design makes it a powerful instrument for labs performing simple or complex applications.

December 2013—Definiens AG, a health care company that advances personalized medicine through image-analysis and digital pathology solutions, and Advanced Cell Diagnostics (ACD), a provider of products and services for molecular pathology, announced the commercial launch of RNAscope SpotStudio, a custom-designed image-analysis software application for ACD’s RNAscope assays to detect and quantify RNA biomarkers.

December 2013—Torrey Pines Scientific’s new EchoTherm stackable, programmable chilling incubators have a 27-L capacity and are Peltier based for heating and chilling. The incubators have no compressors or CFCs and are vibration free, making them ideal for protein crystallizations. Additional applications include incubating marine samples below room temperature, enzyme reactions and deactivations, hybridizations, ligations, and storing oocytes.

December 2013—BioTheranostics announced that Mayo Clinic and Mayo Medical Laboratories will offer the company’s CancerType ID molecular cancer classification test to aid in the management of patients with metastatic cancer.

December 2013—Quidel and Life Technologies announced that the FDA has granted 510(k) clearances to the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV+hMPV assay, both for use on the QuantStudio Dx Real-Time PCR instrument by Life Technologies.

December 2013—Skuldtech, a genomic biomarker company, has secured EUR 1 million in funding from Bpifrance (French public financing structure) as part of a project on Alzheimer disease that has received funding of EUR 8.6 million in total. The program is scheduled to last four years, with the first results expected in 2018.

December 2013—Randox’s two new controls, Acusera Liquid Assayed Chemistry Premium and Premium Plus, are designed to drastically cut the number of individual quality controls a laboratory needs to run in routine medical testing while providing clinically significant values for a wide range of analyzers at key decision points.

December 2013—Novartis announced a definitive agreement to sell its blood transfusion diagnostics unit to Grifols for $1.675 billion. The transaction is expected to be completed in the first half of 2014.

December 2013—Transgenomic has entered into a collaborative agreement with PerkinElmer to market and distribute Transgenomic’s oncology diagnostic test portfolio of products in territories outside the United States.

December 2013—Illumina announced the launch of its TruGenome Undiagnosed Disease Test provided by the CLIA-certified, CAP-accredited Illumina Clinical Services Laboratory. This new service uses whole genome sequencing to assist physicians in identifying the underlying genetic cause of a rare or undiagnosed disease.

December 2013—Myriad Genetics launched a new prognostic test, Myriad myPlan Lung Cancer, for patients diagnosed with early stage lung adenocarcinoma. MyPlan Lung Cancer is an RNA expression panel of 31 cell-cycle-progression genes in combination with tumor staging information to determine a patient’s risk of dying from lung cancer within five years.

December 2013—Microbiologics, a St. Cloud, Minn.-based company, has acquired Phthisis Diagnostics. Phthisis’ innovative, patented G-Sphere molecular standards product line will be the foundation for Microbiologics’ move into molecular products and a new division it is forming. G-Sphere standards are synthetic genes that provide controls for virtually any organism or molecular assay.

December 2013—Bio SB, a molecular pathology company based in Santa Barbara, Calif., announced the launch of its Bcl-6 rabbit monoclonal antibody for in vitro diagnostic use. Bcl-6 is a transcriptional regulator gene that codes for a 706-amino-acid nuclear zinc finger protein.

December 2013—Quest Diagnostics now offers BRCAvantage, a suite of four lab-developed genetic tests that identify mutations in BRCA1 and BRCA2 genes. The BRCAvantage test is performed using next-generation sequencing and multiplex ligation-dependent probe amplification to detect all published deleterious mutations in BRCA1 and BRCA2.

The Legato 110 DRS (dual-rate syringe) pump system offers researchers complete flexibility to start two pumps simultaneously for delivery of two independent flow rates.

TriLink BioTechnologies, a provider of custom nucleic acid-based products, announced the launch of MitoPrimers, dilute-and-go primers for mitochondrial DNA PCR amplification and sequencing in forensic identification. The high sensitivity of mtDNA PCR amplification and sequencing allows forensic scientists to obtain information from evidence associated with homicides or other criminal investigations, body identifications, and cold cases, as well as small pieces of evidence containing little biological material.

Bio SB, a molecular pathology company based in Santa Barbara, Calif., has announced that it will partner with Cancer Diagnostics Inc. to distribute the Bio SB line of IHC antibodies, chromogens, and ancillaries in the U.S. market.

Biosearch Technologies, a supplier of oligonucleotide components to the rapidly growing molecular diagnostics industry, announced that it has acquired worldwide rights to TurboFISH technology, a method for rapid single molecule RNA FISH. With the TurboFISH license, Biosearch maintains exclusive access to continuing Stellaris RNA FISH-based inventions from Rutgers, The State University of New Jersey.

Leica Biosystems has signed an agreement to supply HealthTrust, a group purchasing organization and provider of total cost management solutions for health care facilities, with its broad range of histology instrumentation, laboratory consumables, and sample-tracking systems.

Ventana Medical Systems announced the global launch of its BRAF V600E immunohistochemistry test to detect the BRAF V600E mutation in a variety of tumors. The test, launched as a U.S. class I exempt/CE-IVD product, is designed to detect the most frequent BRAF mutation, V600E, which has been found to play a key role in a variety of cancers, including colorectal cancer.

Horizon Discovery has signed a research service agreement with Blueprint Medicines, a patient-driven oncology company developing highly selective kinase inhibitors for genomically defined cancer subsets. Under the terms of the deal, Horizon will support Blueprint’s New Targets discovery platform by deploying its X-Man isogenic cell lines.

Denville Scientific’s new Ultra EZpette high-precision digital pipettors provide accurate and precise liquid dispensing in an ergonomic design.

Beckman Coulter Life Sciences has received 510(k) clearance from the FDA and an import medical device registration certificate from the China Food and Drug Administration for the in vitro diagnostic use of the Navios flow cytometry system.

Diagnovus, a molecular diagnostics company focused on underserved, aggressive, and lesser-known diseases, announced the launch of the Engauge GI Barrett’s Esophagus genomic assay to predict the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in Barrett’s esophagus patients.

Audit MicroControls has added Control LQ Spinal Fluid to its line of daily quality control products. This bi-level reference control consisting of human serum-based solutions simulates patient spinal fluid samples for monitoring the precision of laboratory testing procedures for chloride, glucose, IgA, IgG, IgM, lactate, LDH, microalbumin, microprotein, and sodium.

Haemtech Biopharma Services announced the successful validation of a thrombin generation assay for an intravenous immunoglobulin drug. The assay was validated in 2012 to support the use of TGA as a release assay for Biotest Pharmaceuticals’ FDA biologics license application for BIVIGAM, an immune globulin intravenous (human), 10 percent liquid product. The validated TGA assay was designed and performed on the Calibrated Automated Thrombogram platform from Diagnostica Stago.

Bleach-Rite Spray, manufactured by Current Technologies, has been approved by the EPA to kill Clostridium difficile spores on hard, nonporous surfaces in five-minute contact time. Bleach-Rite is a hospital-grade spray disinfectant/cleaner, ready to use at the 1:10 dilution recommended by the CDC, OSHA, and NCCLS. The solution is stabilized for an extended shelf life with an expiration date on every bottle.

Ventana Medical Systems and Boehringer Ingelheim have entered into an agreement to collaborate on the development of companion diagnostic tests for Boehringer Ingelheim oncology programs.

Hemo Bioscience and Ortho Clinical Diagnostics have developed an exclusive arrangement for distribution of two new HBS products.

NanoString Technologies has received FDA 510(k) clearance for its Prosigna breast cancer prognostic gene signature assay. Based on the PAM50 gene signature, Prosigna is the company’s first FDA-cleared in vitro diagnostic assay and uses the gene-expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna assay is performed using the nCounter Dx analy

Terumo BCT has received FDA 510(k) clearance for single-needle therapeutic plasma exchange (SN-TPE) on its Spectra Optia apheresis system. This option gives therapeutic apheresis operators the ability to convert to SN-TPE at the beginning or at any time during the procedure, depending on patient needs.

Illumina launched its TruSight One sequencing panel, which targets 4,813 genes with known associated clinical phenotypes. Clinical research laboratories can use this panel to expand existing menus, streamline workflows, or create an entire portfolio of sequencing options, with benefits including increased productivity, reduced handling errors, and decreased costs.

Air Science’s Purair Bio safety cabinet is designed to protect individuals, the environment, and products from a variety of biological particulates, serving as the primary barrier in life science research and experimentation.

PAML, through a partnership with Verinata Health, is now offering the Verifi prenatal test for all patients within the network desiring noninvasive prenatal testing to detect Down syndrome, Edwards syndrome, Patau syndrome, and sex chromosome abnormalities, the most common genetic abnormalities tested for during pregnancy.

Wheaton CryoELITE tissue vials feature a wide-mouth opening, 5-mL capacity, and high-integrity closure. The vials offer researchers who work with biological tissue sections ease of use, convenience, and security.

Smart Imaging Technologies’ Interactive Web Reports for its Simagis Live Digital Pathology servers make it possible for pathologists to complete and sign off digital cases, create professional, media-rich reports from digital slides, and share them instantly with clients, colleagues, or patients.

SciGene’s new sodium thiocyanate pretreatment reagent, a convenient 1-M liquid formulation of NaSCN for pretreating tissue samples prior to application of nucleic acid probes for cytogenetic assays, joins an expanding line of FISH slide-processing products from SciGene.

Enzo Life Sciences’ high-efficiency BioArray conversion kits for detecting 5-mC and 5-hmC modifications (Express DNA methylation kit, blood and tissue DNA methylation kit, and BioArray 5-hmC methylation kit) allow for resolution of single-nucleotide changes without introducing DNA damage. Features such as capacity for multiple sample inputs, rapid processing time, and high-conversion efficiency rate provide enhanced flexibility without sacrificing performance.

Clean Collect blood culture kits, available from Stone Medical, prevent contamination of blood cultures using a patented diversion method.

The Allegra X-5 air-cooled benchtop centrifuge from Beckman Coulter Life Sciences is designed specifically for clinical sample preparation. Bundled packages, which include swinging bucket rotors and common adapters, enable fast and convenient setup and are offered for a range of clinical sample prep applications.

Denville Scientific’s new line of microscopes includes basic and advanced models designed to provide maximum optical performance on durable and affordable platforms.

The selection includes epifluorescence and stereo-zoom models as well as models with trinocular camera and video mounts. A range of objectives are available, and all microscopes come with a five-year mechanical warranty.

The Clinical and Laboratory Standards Institute has published an updated version of “MM07-A2–Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline–Second Edition.” This document addresses FISH methods for medical genetic determinations, identification of chromosomal abnormalities, and gene amplification.

Waters Corp. has unveiled its Web-based Oasis method development tools, which are designed to help customers reduce their sample preparation method development time as part of Waters’ simple prep campaign.

The Liquidator 96 bench-scale manual pipetting solution from Mettler Toledo subsidiary Rainin Instrument provides accuracy without forcing operators to contend with electronic systems or complex computer programming.

Luminex announced it has received FDA and European clearance for a comprehensive genotyping assay, xTAG CYP2C19 kit. This new test provides a personalized approach to determining patient treatment based on certain genetic variants of the P450 2C19 gene.

Multisorb Technologies offers its Quality by Design (QbD)-based Calculations through Operations Program. Multisorb’s scientists use the program to determine the optimized sorbent for the application and to manage placement of that sorbent during packaging operations, when required, with the use of a sorbent-specific dispenser. The program and use of a Multisorb system provide an effective solution for ensuring chemical and ...

SISCAPA Assay Technologies (SAT) announced publication of a study in Clinical Chemistry demonstrating that one of the company’s MALDI-TOF assays for protein C inhibitor can help identify patients at risk for recurrence of prostate cancer after radiotherapy. The assay measures a proteotypic peptide of protein C inhibitor enriched from tryptic digests of patient serum by anti-peptide antibodies (the SISCAPA, or ...

Sagentia has completed initial alpha prototype development of the Resolution microbial genotyping system that it is developing for PathoGenetix. Sagentia has worked with PathoGenetix for the past two years across the full product development life cycle, helping to combine two bread board systems into an intuitive, usable system with a smaller footprint. The Resolution system is based on PathoGenetix’s Genome ...

AACC 2013 AB Sciex has introduced its Sciex IVD-MS kits, which are a new series of reagent kits for in vitro diagnostic use in conjunction with mass spectrometry instrumentation for clinical analysis in Europe. The first kit is focused on vitamin D analysis and is CE-Marked to meet European regulatory requirements. The Sciex IVD-MS kit for 25-OH vitamin D analysis ...

AACC 2013 AB Sciex has launched in Europe its 3200MD CE-IVDD series, which includes the API 3200MD and 3200MD QTRAP LC/MS/MS systems. The systems are now CE-Marked. AB Sciex, 800-343-1346

AACC 2013 AB Sciex’s MPX TF 1.0 software is designed to accelerate drug screening, with accurate mass-based technology for laboratories performing clinical research. The software delivers faster turnaround times, increased sample throughput, and lower costs compared with single-stream, mass spectrometry (MS) methods. With the MPX TF software, researchers can increase throughput by as much as twofold. This is made possible ...

The Binding Site now offers a specifically formulated and optimized ELISA procedure for the quantitation of intact human IgG from matrices containing non-human proteins. The assay is for clinical, biopharmaceutical, and medical researchers. The ELISA uses sheep polyclonal antibody, specific to the Fc and light chain regions of human IgG for capture and detection respectively, ensuring that only intact human ...

The Binding Site now offers a substrate-chromogen containing 3,3’,5,5’-tetramethylbenzidine (TMB). Designed for use as an integral component in peroxidase-based, colorimetric techniques, the TMB chromagen-substrate is for use in enzyme immunoassay test procedures. The TMB substrate-chromagen demonstrates decreased sensitivity to light when compared with other peroxidase chromogens and can be developed without any special precautions. Offered in a liquid-stable, ready-to-use format, ...

The Binding Site now offers a specialized line of anti-human serum protein antibodies. Through the use of a patented technique, which yields highly specific antibodies, all available products display a high degree of purity, shelf-life stability, and lot-to-lot consistency. The range of specialized antibodies includes those involved in blood coagulation, complement activation, acute-phase reactants, immunoglobulin response, and others. The antibodies ...

Thermo Fisher Scientific has launched its Barnstead GenPure xCAD Plus water purification system, which has technology that allows simultaneous dispensing from three remote dispensers for exceptional flexibility and ease of use in shared laboratory environments. In addition to its advanced dispensing technology, the Barnstead GenPure xCAD Plus is easy to use and comes with leak detection, feed water monitoring, and ...

The FDA in June approved a workflow process for Roche Diagnostics’ Cobas HPV test that allows sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing. The approval allows labs to load the same vial used for a ThinPrep Pap test directly onto Roche’s Cobas 4800 system for high-risk HPV and individual HPV ...

Roche’s Cobas 8100 automated workflow series is an advanced system designed to automate many routine tasks to help diagnostic laboratories increase efficiency, reduce expenses, and maximize patient safety. Through intelligent robotics, the Cobas 8100 series automatically prepares blood samples for immediate testing and post-analytical processing, providing high-speed processing of up to 1,100 samples per hour. The system offers dynamic and ...

Tosoh Bioscience’s ST AIA-Pack 25-OH vitamin D assay is for use on most Tosoh AIA system analyzers. Vitamin D measurement is intended as an aid in the determination of vitamin D sufficiency. Using Tosoh’s unit-dose test-cup reagent technology, ST AIA-Pack 25-OH vitamin D has an assay time of about 40 minutes. Single, unitized test cups require no premixing, no premeasuring, ...

Samsung Electronics presented details of the first peer-reviewed report of a pilot conducted with the National Health Service in Scotland, Borders General Hospital, the Scottish Ambulance Service, and the Scottish Centre for Telehealth and Telecare on the use of the company’s Labgeo IB10 portable blood analyzer to diagnose cardiac patients in transit to the hospital. Conducted in the sparsely populated ...

Cepheid has received FDA market authorization for its Xpert MTB/RIF test, which provides results in about two hours. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be downclassified and brought to market. Xpert MTB/RIF is for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens ...

September 2013—Abbott has received FDA approval to expand the use of its RealTime HIV-1 assay to run on the company’s mPlus system. In April, Abbott introduced mPlus capability for its RealTime m2000 system to enhance the system’s flexibility and make molecular testing easier and more efficient for laboratories.

AACC 2013 Abbott announced results from a study evaluating its high sensitive troponin-I (hsTnI) assay. The study, conducted by researchers at Brigham and Women’s Hospital, demonstrated that Abbott’s Architect stat hsTnI test may help doctors predict which patients presenting with symptoms of a heart attack are at a higher risk for having a heart attack 30 days after presentation. Researchers ...

Eppendorf North America offers a new generation of its ThermoMixer and ThermoStat incubators. The excellent mixing results of the ThermoMixer C, F1.5 and FP (two-in-one instruments for combined mixing and incubating) are due to the company’s two-dimensional mix-control technology, which ensures fast and efficient mixing in seconds. Through controlled circular movements, liquids in small volumes are thoroughly mixed, while anti-spill ...

Seegene has launched its multiple mutation detection technology to accelerate the development of companion diagnostic tests. The technology transforms conventional real-time instruments into powerful systems to simultaneously detect multiple mutation targets in a single channel. Seegene has extended the capabilities of its real-time PCR technology to simultaneously detect more than 20 different mutations, including insertions, deletions, and point mutations, in ...

Greiner Bio-One’s Vacuette Tube-Touch passive safety device has a passive safety shield that activates upon tube insertion, reducing the risk of exposure to bloodborne pathogens from a needlestick. The product comes to the customer completely assembled with a needle, safety shield, and tube holder. Greiner Bio-One, 888-286-3883

Streck’s A1c-Cellular Linearity, an HbA1c linearity/calibration verification material with intact red blood cells, is now assayed for Roche Diagnostics’ Cobas c 311. It is a five-level assayed linearity material used to assess instrument accuracy and verify the patient reportable range of the HbA1c parameter. The product does not require reconstitution, which reduces the potential for human errors and saves time. ...

Radiometer America offers its “Avoid Errors” application for the iPhone. The app allows users to identify typical preanalytical errors in blood gas testing. The content of the “Avoid Errors” application is threefold, with tips on how to prevent errors, a troubleshooting section, and a skill test. A handbook section in the app contains videos that show how to properly collect ...

Wako Diagnostics was issued three class III medical device licenses by Health Canada to market the uTAS-Wako i30 instrument with the serum biomarkers lectin-reactive alpha-fetoprotein (AFP-L3) and des-gamma-carboxy prothrombin (DCP) for clinical use in Canada. The AFP-L3 and DCP tests are intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma.

Seegene announced that BioMérieux has licensed the company’s DPO and TOCE technologies for the development of multiplexed tests for food safety.

Magellan Diagnostics has received FDA 510(k) clearance to market its LeadCare Ultra benchtop blood lead testing system in the United States.

Current Technologies’ Bio-Hazard wipes protect patients and employees from cross-contamination when opening and handling specimen containers and sputum cups. The white side of the Bio-Hazard wipe absorbs specimen contents and sputum, while the orange plastic backing prevents splash or leakage from containers to gloves.

Horizon Discovery has entered into a nonexclusive license agreement with Sigma-Aldrich for use of its CompoZr zinc finger nuclease (ZFN) technology.

BD Diagnostics announced FDA clearance of its BD ProbeTec Trichomonas vaginalis Qx amplified DNA assay for the direct qualitative detection of T. vaginalis DNA in endocervical samples, vaginal samples, and neat urine specimens. This assay, developed to aid in the diagnosis of trichomoniasis, has been CE marked to the in vitro diagnostic directive.

SeraCare Life Sciences has acquired Kirkegaard & Perry Laboratories (KPL), a provider of antibodies and related reagents for the diagnostic and life sciences markets.

Thermo Fisher Scientific’s ImmunoCAP peanut component tests are now available through Quest Diagnostics. Unlike skin scratch testing, the ImmunoCAP peanut component tests measure a patient’s IgE sensitization to five individual peanut proteins, or allergen components.

BioTheranostics, a provider of molecular diagnostic solutions for cancer, has received a positive coverage decision and in-network provider status from Tufts Health Plan for its CancerType ID molecular cancer classifier. CancerType ID predicts tumor type in patients with metastatic cancers.

Diagnostica Stago offers expertise through two free electronic resources to educate health care professionals about hemostasis and thrombosis. The Stago-EdVantage Web site and iHemOStasis app for the Apple iPad offer ways to increase hemostasis knowledge; understand clinical situations, therapies, and detection methods; and apply practical skills to patient care.

Illumina and Natera announced they have entered into a three-year agreement whereby Illumina will supply Natera with the HiSeq 2500 sequencing system and associated consumables for performing Natera’s noninvasive prenatal test (NIPT) Panorama.

Audit MicroControls’ Linearity FD General Chemistry Beckman AU simulates human patient serum samples for determining linearity, calibration verification, and verification of reportable range for albumin, alkaline phosphatase, ALT, total amylase, AST, total bilirubin, direct bilirubin, BUN, calcium, chloride, cholesterol, CO2, creatine kinase, creatinine, gamma-GT, glucose, iron, lactate, LDH, lipase, magnesium, phosphorous, potassium, sodium, total protein, triglycerides, and uric acid. This five-level lyophilized product, packaged as 10 × 5 mL, has a shelf life of two years and open-vial stability of seven days when stored at 2°C to 8°C.

A new study, conducted by researchers at the John A. Burns School of Medicine, University of Hawaii, and published in the Journal of Microbiology, evaluated the InBios DENV Detect IgM capture ELISA for qualitative detection of IgM antibodies to dengue virus recombinant antigens. Well-characterized clinical serum samples collected from Hawaii, Vietnam, Niue, Singapore, and American Samoa were tested with the InBios ELISA in comparison with an in-house DENV IgM antibody capture (MAC) ELISA. The agreement, sensitivity, and specificity of the InBios assay were 94, 92, and 94 percent, respectively.

AdvanDx, a provider of molecular diagnostic tests for identifying pathogens that cause critical infections in hospitalized patients, announced the commercial launch of Gram-Negative QuickFISH BC, the third FDA-cleared test in its QuickFISH blood culture pathogen identification platform.

GeneDx announced the launch of a comprehensive suite of genetic tests for inherited cancer, including a 26-gene panel for breast and ovarian cancer that includes BRCA1 and BRCA2 and next-generation sequencing-based multi-gene panels for colorectal cancer, pancreatic cancer, and endometrial cancer.

Next-generation sequencing technologies have become faster and more efficient while library preparation remains a bottleneck. Laboratories require high-throughput, high-quality, stable, clinically relevant, and reproducible sample preparations. Solutions to these problems must not only solve time constraints but do so without the human errors associated with manual methods.

Myriad Genetics’ myRisk Hereditary Cancer is a multi-gene diagnostic test that provides increased sensitivity by analyzing 25 genes associated with eight major cancers, including breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric, and melanoma.

Each test report will include a genetic test result, a clinical risk report, and a health care management tool based on professional society guidelines, providing clear and actionable information to improve patient care regardless of whether the patient receives a positive or negative test result.

Thermo Fisher Scientific’s Peltier-cooled incubators with solid-state Peltier cooling are for biological and genomics laboratory researchers engaged in fruit fly and biochemical oxygen demand research.

Abbott will add a new FDA-cleared molecular diagnostic test for detection and differentiation of influenza A and B and respiratory syncytial virus to its infectious disease testing menu. The IMDx Flu A/B and RSV test developed by IntelligentMDx (IMDx) of Cambridge, Mass., is performed on Abbott’s m2000 molecular diagnostics system.

The Clinical and Laboratory Standards Institute has released an updated edition of its standard NBS01-A6 (replaces LA04-A5), “Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard-Sixth Edition.” This document contains new information and insight for personnel on the essentials of correctly collecting a high-quality specimen, handling the specimen after it has been collected, transporting it to the testing facility, and sorting the residual specimen that remains after laboratory testing.

Diagnostic BioSystems added a new chromogen to its color spectrum—PermaBlack/HRP. This HRP-based substrate/chromogen system produces a sharply contrasting ebony black stain, which serves as a useful tool in immunohistochemical and in situ hybridization staining procedures.

September 2013—Life Technologies and RainTree Oncology Services have entered into a collaborative agreement designed to further the advancement of personalized care for cancer patients.

Seegene has entered into a collaborative agreement with Eidia, the in vitro diagnostics subsidiary arm of Eisai Co., headquartered in Japan. Through this agreement, Eidia gains access to Seegene’s portfolio of Toce technology-based multiplex molecular diagnostic tests for the Japanese diagnostic test market.

The CHU de Québec, a health care institution in Québec, and Copan Diagnostics announced the full installation of the WASPLab laboratory automation and digital microbiology system in Hôpital de l’Enfant-Jésus, one of the five hospitals forming the CHU de Québec.

Horizon Diagnostics has signed a distribution agreement with Riken Genesis under which Riken will become the sole distributor of HDx’s molecular reference standards in Japan. Riken Genesis offers genomic products and services to a range of research institutions and corporations and is a CAP-accredited laboratory for genome analysis services.

SeraCare Life Sciences has introduced a new AccuSet anti-Toxoplasma performance panel.

BioFire Diagnostics has begun clinical and analytical studies at several hospital-based laboratories in the U.S. to evaluate the company’s FilmArray gastrointestinal panel. BioFire plans to seek CE IVD marking and FDA clearance for the test.

ELITechGroup Biomedical Systems has launched a new Series 2 generation of Aerospray slide stainers. The stainers have large touchscreens, bar-code readers, and intuitive user interfaces with language selection and help screens.

The Eppendorf Tube 5.0 mL system, from Eppendorf North America, handles volumes up to 5 mL. The tubes feature a snap cap for single-hand operation and a compact conical design, removing the risk of contamination associated with manipulating small volumes in large tubes.

Beckman Coulter Life Sciences has acquired the flow cytometry business assets of ReaMetrix India, a Bangalore-based life science technology company. The transaction provides Beckman Coulter with temperature-stable, single-dose, multi-color antibody cocktails targeting the HIV monitoring and clinical research markets.

Mercy Medical Center in Canton, Ohio, has implemented advanced clinical laboratory diagnostic technology for conducting on-demand HbA1c diabetes testing, as well as analysis of red blood cell, white blood cell, and platelet counts. Mercy did this by installing Sysmex America’s XN-9000 Lavender Top Management configuration. As North America’s first installation of its kind, the Sysmex Lavender Top Management system, designed ...

NorDx, a large reference laboratory in Maine that is a member of MaineHealth, has acquired Sysmex America’s XN-3000 automated hematology analyzers. The XN-3000 configuration enables enhanced diagnostic capabilities and greater efficiency that transforms NorDx into an accountable care laboratory model. The Sysmex XN-3000 has a menu of advanced clinical parameters that allows NorDx and MaineHealth to conduct cellular studies that ...

Ontario-based Brockville General Hospital and Sysmex Canada announced the hospital’s installation and implementation of a Sysmex XN-2000 automated hematology analyzer. This is the first Sysmex XN series analyzer to be installed in Canada. The compact automated hematology analyzer provides the hospital’s clinical laboratory with expanded clinical and operational capabilities to meet changing workload demands and testing complexity that may accompany ...

Sysmex America recently introduced its Sysmex XP-300, an update for smaller labs in the U.S. and recently introduced to the Latin America and Caribbean market, as well as its Sysmex DI-60 integrated slide processing system, which provides seamless integration of automated slide making/staining and digital cell image classification. The Sysmex XP-300 automated hematology analyzer is part of the company’s three-part ...

EKF Diagnostics offers a novel test to accurately identify diabetic patients at high risk of progression to end-stage renal disease (ESRD) up to 10 years before currently available tests can. EKF’s sTNFr1 test is an ELISA assay that has the potential to significantly improve diabetic patient management and outcomes. The test accurately detects circulating levels of soluble tumor necrosis factor ...

EKF Diagnostics offers its Stat-Site M Hgb strip-based test for quick and easy hemoglobin analysis for rapid anemia determination. Stat-Site M Hgb is a portable handheld analyzer. The pocket-sized device delivers accurate hemoglobin analysis results within 30 seconds from 15 µL of fingerstick whole blood. This hemoglobin photometer is maintenance-free and includes intuitive, step-by-step on-screen instructions to minimize operator training. ...

EKF Diagnostics’ Stat-Site M β-HB is a strip-based test for β-hydroxybutyrate that provides a quick and easy assessment of diabetic ketoacidosis (DKA), delivering results in less than 80 seconds. The presence and degree of ketosis can be assessed rapidly at the point of care by accurately measuring blood levels of β-HB, which accounts for 78 percent of the three ketone ...

EKF Diagnostics offers its EKF Molecular Diagnostics’ PointMan DNA enrichment kits. The three kits are for enriching mutations in BRAF, KRAS, and EGFR T790M genes associated with skin melanoma and colorectal and lung cancers. PointMan kits provide highly specific and ultrasensitive enrichment of mutant genes in a background of wild-type (normal) genes. PointMan real-time PCR technology provides reliable and extremely ...

The IVD Industry Connectivity Consortium (IICC) has developed a laboratory analyzer workflow (LAW) interface, which is a global interface based on a common set of clinical laboratory communications that unambiguously define communication protocols. In 2012, four diagnostic and three IT companies successfully validated 129 LAW tests. Since then, IICC has refined these interfaces and is asking more manufacturers to adopt ...

Cerilliant offers seven new certified spiking solutions of bath salt metabolites. The new products are 1.0 mg/mL (as free base) in methanol for the primary urinary metabolites of bath salt cathinones, mephedrone, buphedrone, pentedrone, flephedrone, N-ethylcathinone, and 4-methylethcathinone. For GC/MS and LC/MS methods that quantify concentrations of synthetic cathinone metabolites, the company also offers the corresponding deuterium-labeled internal standard. Cerilliant ...

Cerilliant offers certified Snap-N-Spike solutions of thyroid hormones T4, T3, and reverse T3 at concentrations of 100 µg/mL in 0.1 N ammonia in methanol for each solution standard. These certified spiking solutions are for use as critical starting materials in the preparation of calibrators, controls, or linearity standards for analytical testing including LC-MS/MS analysis of free and total thyroid hormone ...

Life Technologies in February received FDA 510(k) clearance for its 3500 Dx genetic analyzers and SeCore HLA typing kits. The company’s 7500 Fast Dx real-time PCR system was cleared for diagnostic use with the CDC’s H1N1 assay in 2008. The Applied Biosystems 3500 Dx/3500xL Dx CS2 genetic analyzers, Invitrogen SeCore HLA sequencing kits, and uType Dx HLA sequence analysis software ...

NanoString Technologies’ nCounter Elements are digital molecular bar-coding chemistry assay components that allow users to assemble their own assays with oligonucleotide probes that target their genes of interest. The components enable highly multiplexed, direct profiling of individual molecules in a single reaction without amplification and are effective for a range of applications requiring efficient, high-precision quantitation of tens to hundreds ...

Quidel Corp. and Life Technologies in March received FDA 510(k) clearances to market the Quidel Molecular Direct C. difficile assay with Life Technologies’ QuantStudio Dx and 7500 Fast Dx Applied Biosystems real-time PCR instruments. The C. difficile assay is part of Quidel’s molecular diagnostic product line, which includes PCR reagent kits for molecular diagnostic laboratories including Life Technologies’ QuantStudio Dx and ...

Life Technologies’ Oncomine Next-Gen Sequencing Power Tools is an analytics offering that will allow cancer researchers to explore results from in-depth analysis of next-generation sequencing (NGS) data, including data from The Cancer Genome Atlas. In total, more than 4,500 paired tumor and samples have been analyzed. Oncomine NGS Power Tools constitute a suite of software tools that enable cancer researchers ...

Through a distribution agreement with Alifax, Beckman Coulter and Iris Diagnostics have launched the Alifax automated erythrocyte sedimentation rate (ESR) analysis system. The automated ESR analysis systems are designed to fit the workloads of small hospitals, large reference laboratories, core laboratories, and satellite locations. The ESR system increases productivity, improves efficiencies in laboratory labor use, and reduces turnaround times. The ...

Beckman Coulter’s FDA-approved hemoglobin A1c assay (HbA1c) with improved performance is for standard use on the company’s UniCel DxC systems. The HbA1c reagent was designed and developed to improve accuracy and precision, to continue to meet the latest accuracy grading from the College of American Pathologists and the recommendations of the National Glycohemoglobin Standardization Program and International Federation of Clinical ...

Beckman Coulter’s FDA-cleared Access AccuTnI+3 troponin I assay is available for use on the company’s Access 2 immunoassay system. In accordance with FDA requirements, the company conducted a large multicenter prospective clinical trial on the AccuTnI+3 troponin I assay that enrolled more than 1,900 subjects. The trial confirmed that the assay provides the clinical performance necessary for optimal patient management. ...

Beckman Coulter’s UniCel DxH 600 Coulter cellular analysis system is for mid- to high-volume laboratories. The benchtop hematology analyzer—with advanced software—provides laboratories with exceptional quality results, improved first-pass accuracy, and automatic rerun and reflex testing, thereby reducing overall manual review rates and processes. The UniCel DxH 600 is equipped with software that saves time by allowing labs to partially release ...

Beckman Coulter’s Remisol Advance data-management system, v1.7 streamlines laboratory workflow and the result management process by improving sample tracking and results archiving, and through consolidating patient test information from multiple instruments in the lab or from multiple labs in the hospital network. Remisol Advance v1.7 unifies data management and features a 166 percent increase in sample data processing throughput and ...

Siemens Healthcare Diagnostics’ VersaCell X3 solution helps labs achieve the workflow benefits of automation without the space or budget considerations of a track-based solution. The platform connects up to three Siemens analyzers through one robotic sample interface, thus increasing productivity. By supporting a customized mix of chemistry, immunoassay, and/or integrated systems and associated assay menus, the VersaCell X3 solution helps ...

SeraCare Life Sciences completed its implementation of SAP enterprise resource planning (ERP) software. The SAP system integrates the company’s inventory planning and control, purchasing, production management, quality management, and financial reporting systems into a single software solution.

Medica’s Competency Review software for its EasyCell assistant cell imaging system for hematology labs integrates evaluations of technologists into the laboratory’s daily routine. With the software, an instructor can train and evaluate the expertise of technologists in classifying white cells and red cell morphology.

Audit MicroControls received 510(k) clearance from the FDA, allowing the addition of assayed lithium to Audit’s therapeutic drug monitoring daily quality control and calibration verification/linearity kits. With the addition of lithium, Audit’s TDM linearity kit will have five levels and 14 assayed analytes and the control will have three levels and 13 assayed analytes.

Diagnostica Stago expanded its line of automated hemostasis analyzers with the launch of the STA Compact Max Hemostasis Testing System, a coagulation testing solution for mid- to high-volume laboratories. The new touchscreen user interface enables intuitive operation at any skill level, and the system’s integrated expert module offers autoverification, expert rules, an advanced QC system, and electronic lot conversion.

Beckman Coulter Life Sciences’ new reagent kits for intracellular staining minimize sample manipulation for a streamlined workflow. Developed for use on Beckman Coulter’s Gallios and Navios series flow cytometers and compatible with all Beckman fluorochromes, the kits enable a clear focus on the cytoplasmic and nuclear compartments of the cell.

Gold Standard Diagnostics announced FDA 510(k) clearance of its 25-OH vitamin D, total ELISA. This assay correlates with established liquid chromatography/mass spectrometry, enzyme immunoassay, and chemiluminescence methods, and offers high sensitivity and specificity over a wide dynamic range. The assay can be automated on a variety of instruments, providing a cost-effective vitamin D testing option even at lower volumes.

Seegene’s novel real-time array technology is designed to accelerate the development of point-of-care testing by eliminating steps that normally follow PCR amplification, and that are required for conventional arrays. The new technology unifies all the steps into one. There is no size limitation for the PCR amplicon, and the array technology requires no asymmetric PCR, denaturation of the PCR amplicon, target specific primer extension, signal amplification, or washing step.

Alere has received FDA approval to market its Alere Determine HIV-1/2 Ag/Ab Combo in the United States. The Alere Determine HIV-1/2 Ag/Ab Combo is a rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.

BD Diagnostics and Diagenode announced the European-only launch of the Diagenode Bordetella pertussis/parapertussis real-time PCR kit for use on the BD Max system. The kit has been CE-marked and validated to run on the BD Max system using the BD Max ExK DNA-1 extraction kit, an open-system reagent. BD Diagnostics, 800-675-0938 Diagenode, 862-209-4680

PolyScience’s performance programmable circulating baths make it simple to create and run multi-step ramp and soak temperature programs as well as frequently used single temperature testing protocols. The baths have an icon-driven touchscreen display that makes it easy to select and set operational parameters. A built-in electronic keypad speeds and simplifies the entry of text and numerical values. Available in ...

Qiagen announced a partnership with Exosome Diagnostics to develop and commercialize high-performance biofluid sample preparation kits for the processing of nucleic acids from exosomes. Combining Exosome Diagnostics’ platform technology approach with select Qiagen consumables and automation platforms has the potential to allow researchers, drug developers, and medical professionals to take repeated, real-time genetic “snapshots” of disease from patients’ blood, urine, ...

Immunetics has received FDA clearance for its BacTx rapid test for bacteria in apheresis platelets. The BacTx system is a colorimetric assay that can detect aerobic, anaerobic, gram-negative, and gram-positive bacteria in a single test. The BacTx assay uses a patented, specific, universal bacterial detection reagent that has been shown to detect wild and cultured bacterial strains. BacTx is intended ...

ELGA Process Water introduces the Medica Pro electrodeionization (EDI) water purification system. The system consistently produces high-purity water at economical running costs for immunochemistry and general chemistry automated clinical analyzers. ELGA’s Pulse technology combined with extended intervals between sanitization reduces maintenance time.

Diagnostic BioSystems’ anti-PIN5 cocktail helps distinguish prostate cancer from benign conditions that mimick cancer. The cocktail works through the combined detection of p504S, p40, and high molecular-weight cytokeratin markers. The markers are particularly relevant in helping to diagnose prostatic intraepithelial neoplasia. The markers also offer utility in difficult cases where tissue may be limited.

Sysmex America has renewed its agreement to distribute Medica’s EasyCell assistant for digital cell image analysis in hematology laboratories. EasyCell uses optical pattern recognition software to automatically locate white cells on a blood smear. It digitally stores, preclassifies, and presents images for review, grouped by cell type, on an LCD display.

Randox Laboratories has received FDA approval for its Acusera immunoassay specialty 1 control for use in U.S. laboratories. The multi-analyte, lyophilized control contains I-25-(OH)2-vitamin D, 25-OH-vitamin D, C peptide, insulin, insulin-like growth factor-1, procalcitonin, parathyroid hormone, anti-thyroglobulin, and anti-thyroperoxidase.

SciGene’s CytoZyme stabilized pepsin is an advanced formulation of pepsin for pretreating tissue samples in nucleic acid probe-based cytogenetic assays, including FISH.

Genomic Health made its Oncotype DX prostate cancer test available recently after a presentation of a positive clinical validation study by the University of California, San Francisco, at this year’s American Urological Association annual meeting.

The Center for Phlebotomy Education is conducting a three-day seminar for those who train or manage phlebotomists. It will take place Nov. 6–8 at the Brown Hotel in Louisville, Ky. The staff of the Center for Phlebotomy Education will conduct the sessions. They are program administrator Catherine Ernst, RN, PBT(ASCP); program coordinator Lisa Steinam, PBT(ASCP); and executive director Dennis J. Ernst, MT(ASCP).

Helmer Scientific’s i.Series and Horizon Series under counter refrigerators and freezers are available in ADA-compatible models. These models are designed to fit under 34-inch ADA-compliant counters and offer chamber temperature uniformity with quick recovery, bacteria-resistant powder coating, and a self-closing door with magnetic latch.

Qiagen is expanding its next-generation sequencing portfolio of nine GeneRead DNAseq panels to about 20 during the course of this year. Qiagen is leveraging its molecular content and assay portfolio to create these new gene panels for targeted NGS analysis based on the GeneGlobe portfolio of more than 60,000 annotated molecular assays.

Primera Technology now offers its chemical- , temperature- , and abrasion-resistant TuffCoat 2 (TC2) high-performance ink ribbons for its Signature Slide Printer. The new ribbon formulations were developed specifically to provide superior performance in pathology, histology, cytology, and other types of laboratory applications.

The FDA has approved GlaxoSmithKline’s Tafinlar (dabrafenib) and Mekinist (trametinib) oral oncology treatments. Tafinlar is indicated as a single-agent oral treatment for unresectable melanoma or metastatic melanoma in adult patients with BRAF V600E mutation.

Milestone Medical’s BoneStation is a dedicated system for standardizing fixation and decalcification of bone specimens. Users can optimize molecular testing results with increased RNA yield from routine cases by combining less aggressive decalcifying solutions with BoneStation’s controlled agitation and temperature management.

Immunodiagnostic Systems has received FDA clearance for its 1,25-dihydroxy vitamin D assay for use on the IDS-iSys system. The vitamin D test is used to measure 1,25-dihydroxy vitamin D deficiency, which is associated with renal disease and used in the diagnosis of disorders in the metabolism of 25-hydroxyvitamin D and phosphate.

Gold Standard Diagnostics’ new Line Immunoassay technology for Lyme confirmation testing gives clinical laboratories an FDA-cleared option for serological confirmation testing for Lyme disease according to the CDC-recommended two-step process.

Randox Laboratories and Aterovax have announced a strategic partnership to commercialize Aterovax’s secreted phospholipase A2 (sPLA2) biomarker for the assessment of cardiovascular risk.

The HardyChrom SS, from Hardy Diagnostics, is a selective chromogenic medium recommended for use as a primary screening medium for isolating and differentiating Salmonella and Shigella spp from stool cultures.

Sarstedt collection products for arterial and capillary blood gas determinations, consisting of 1-mL and 2-mL plastic blood gas syringes, contain a fine dispersion of calcium-balanced heparin, resulting in a large surface area for good solubility and quick mixing.

Dualsystems Biotech’s DualMembrane system detects novel interaction partners for membrane proteins and can be used to detect pairwise protein interactions, identify novel protein interactions by cDNA library screening, investigate ternary complexes, and map interaction domains. The system is available as a kit or custom screening service.

Bio SB now offers HRP Green, a vibrant chromogen to help clinical and research laboratories detect IHC markers on paraffin-embedded tissues. HRP Green comes in a two-part buffer and chromogen format that is compatible with all Bio SB polymer and biotin HRP-based detection systems. HRP Green requires a five-minute incubation period, can be counterstained with Nuclear Fast Red or hematoxylin, and is xylene (PermaMounter) compatible.

August 2013—Vector Laboratories now offers glycoprotein eluting solutions and neoglycoproteins. Five glycoprotein eluting solutions have been generated to complement the company’s range of agarose-bound lectins. These solutions maximize the yield of eluted glycoproteins from the beads and preserve lectin activity for repeat use.

Hamilton Robotics has a new module for its Microlab Star workstation that automates enzyme-linked immunoabsorbant assays (ELISAs). The ELISA StarLet module integrates precision liquid handling instrumentation with multiple devices and sophisticated software.

Leica Biosystems, in partnership with Indica Labs, has launched the HALO next-generation image-analysis software. The HALO platform is fast, scalable, and user-friendly and is for Aperio ePathology image analysis.

Beckman Coulter’s Microfuge 20 and 20R microcentrifuges are designed to meet the specific requirements of a range of research applications and are easy to use. Paired with Microfuge series rotors, the microcentrifuges provide flexibility and reliable, precise performance while occupying a small footprint.

Ventana Medical Systems has signed a worldwide agreement with health care imaging expert Barco to provide Barco’s diagnostic and clinical review display systems for use with Ventana’s Virtuoso image and workflow management system.

Health Canada has approved Life Technologies’ Applied Biosystems 3500 Dx/3500xL Dx genetic analyzers CS2 for diagnostic use. The Applied Biosystems 3500 Dx series genetic analyzers deliver high-quality performance, high throughput, and increased productivity for clinical laboratories. The 3500xL Dx is an automated 24-capillary-based Sanger sequencer; the 3500 Dx is an eight-capillary instrument.

PathCentral announced that Johns Hopkins University School of Medicine’s Department of Pathology will participate as a client in the PathCentral Pathology Network (www.pathcentralpro.net), a comprehensive online information exchange and digital consultation forum.

MDxHealth announced data showing that methylation of the DCR1 gene may help guide oncologists in selecting metastatic colorectal cancer patients to receive irinotecan-based therapy. The data, presented at this year’s ASCO meeting, showed that CRC patients with methylated DCR1 did not benefit from the addition of irinotecan to capecitabine therapy.

EKF Diagnostics’ Stat-Site M Hgb is a portable hemoglobin photometer. The pocket-sized device provides accurate hemoglobin analysis results within 30 seconds from 15 µL of whole blood.

Siemens Healthcare Diagnostics will collaborate with Janssen Pharmaceutica to design, develop, and commercialize a companion diagnostic test associated with an early-stage compound Janssen is developing that targets autoantibodies directed against the human β1-adrenergic receptor that may contribute to the development of heart failure.

Sysmex America was awarded a five-year Cost Per Reportable Result agreement with VA Midwest Health Care Network (VISN 23), a Veteran Integrated Service Network.

Qiagen and SIP Biotech Development have opened the Qiagen (Suzhou) Translational Medicine Center, which aims to accelerate the discovery and validation of biomarkers and to create companion diagnostics for the Chinese market. Qiagen (Suzhou) is a joint venture of Qiagen and BioBay, a life sciences cluster in Suzhou Industrial Park, near Shanghai.

Streck’s Retic-Chex Linearity, designed to establish the patient reticulocyte reportable range and linearity, is now assayed for the Sysmex XN series (XN-10 and XN-20) hematology instruments.

General Data has acquired Triangle Biomedical Sciences. TBS will become a division of General Data Healthcare, which provides specialty products and solutions to hospitals, independent labs, and other health care facilities.

Sarstedt’s S-Monovette blood collection system enables a gentle aspiration draw with no sample transfer.

Chembio Diagnostics’ Sure Check HIV 1/2 assay has received CE Mark approval. The assay is now cleared for commercialization within the EU for rapid point-of-care detection of HIV. The product is FDA approved and distributed in the United States as Clearview Complete HIV 1/2 by Alere.

Audit MicroControls has updated its logo, mission statement, and social media campaign. Audit’s mission is to supply daily QC and calibration verification/linearity materials to clinical labs worldwide while providing support, real-time data-reduction tools, same-day shipping, and quality products at a fair price.

ViroStat offers two new sets of Monotope monoclonal antibodies to the major capsid protein of the GI and GII noroviruses. The new antibodies function in ELISA and lateral flow applications for rapid detection of these viruses.

Quest Diagnostics and Hologic have entered into a strategic alliance to more broadly offer testing based on Hologic’s Aptima family of products, as well as to co-develop and promote advanced diagnostic solutions to improve women’s health.

The FDA has approved a workflow process for Roche Diagnostics’ Cobas HPV test that allows sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing. Labs can load the same vial used for a ThinPrep Pap test directly onto the Cobas 4800 system for high-risk HPV and individual HPV 16 and 18 genotype ...

Biocare Medical’s Supernova antibodies contain a higher antibody concentration than standard predilutes. Clients now have the option of preserving limited tissue specimens while still providing multi-antigen identification in about the same time as an antibody cocktail. This is achieved using Supernova antibodies in sequential incubations combined with Biocare’s double stain detection. Unique cocktails can also be created with ease as ...

Kreatech has signed an agreement with the Lung Cancer Mutation Consortium (LCMC) allowing LCMC study sites to use Kreatech’s Repeat-Free Poseidon fluorescent in situ hybridization (FISH) probes to help identify molecular (DNA) changes in study samples.

Saladax Biomedical has been certified as a registered CLIA laboratory by the Office of Clinical Standards and Quality, a part of CMS that regulates lab testing performed on humans. The CLIA certification and approval allows the company to begin clinical laboratory operations for its MyCare product portfolio at facilities in Bethlehem, Pa.

Siemens Healthcare Diagnostics has obtained FDA clearance to offer pleural fluid pH testing on its RapidPoint 500 blood gas system. The addition of pleural fluid pH testing to the RapidPoint 500 complements the analyzer’s critical care menu, which includes blood gas, electrolyte, glucose, lactate, and full CO-oximetry tests, including neonatal total bilirubin and total hemoglobin.

BG Medicine’s galectin-3 testing has been recognized in the 2013 American College of Cardiology Foundation and American Heart Association (ACCF/AHA) Guideline for the Management of Heart Failure, which is designed to assist clinicians in selecting the best management strategy for patients and provides analysis of prevention, diagnosis, risk stratification, and treatment data.

Thermo Fisher Scientific’s Orbitrap Fusion Tribrid liquid chromatography-mass spectrometry (LC-MS) system combines its quadrupole, Orbitrap, and linear ion trap mass analyzers in a “Tribrid” architecture that analyzes complex biological samples.

Available from LipoScience is NMR (nuclear magnetic resonance) lipoprotein particle testing using the company’s Vantera clinical analyzer through Mayo Medical Laboratories. NMR lipoprotein testing on the Vantera analyzer will be accessible to Mayo Clinic physicians and patients and other hospital clients of Mayo Medical Laboratories.

Beckman Coulter Genomics’ BRAF assay has been granted clinical laboratory licenses in Pennsylvania, Maryland, Rhode Island, and Massachusetts. CLIA certification, plus licensure in those states, allows Beckman to accept clinical samples for genetic sequencing—the most technically complex CLIA category—and provide those results to physicians to use in treating, diagnosing, and preventing disease in patients.

IncellDx has reached an agreement with Kindstar Global to offer its proprietary laboratory test for the detection of oncogenic HPV E6, E7 mRNA in China. Kindstar is a large esoteric diagnostic testing business.

Quest Diagnostics has entered into a definitive agreement to acquire laboratory-related clinical outreach service operations of Dignity Health, a hospital system based in California. Under the agreement, Quest will acquire operations through which Dignity Health provides outreach diagnostic information services to patients and physician offices in parts of California and Nevada.

Quidel Corp. has completed its acquisition of BioHelix Corp. According to terms of the deal, Quidel will pay BioHelix shareholders $10 million in cash, plus additional amounts in connection with an R&D earn-out based on the completion of a designated number of assays and a commercial earn-out dependent on product sales over a defined period.

Applied Spectral Imaging and BioDot have entered into an agreement under which both companies will engage in combined sales and marketing of a product that will directly link ASI’s GenASIs imaging and analysis instrument and BioDot’s CellWriter automated dispensing system for FISH and karyotyping.

Meridian Bioscience has received FDA clearance for its Mycoplasma pneumoniae molecular diagnostic test on the Illumigene platform. By amplifying the specific DNA for the detection of M. pneumoniae, the test provides a definitive result, thus helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner.

Beckman Coulter Life Sciences’ VersaComp antibody capture bead kits are designed to set compensation for multicolor flow cytometry experiments by allowing researchers to use the same reagents as they do in their experiments.

BioMérieux’s Labguard is a real-time wireless, automated, temperature-monitoring solution for hospitals, laboratories, blood banks, and pharmacies. The solution features real-time, 24/7 Web-based monitoring with alarm display and notifications via SMS, e-mail, and fax. The solution has sensor probes for different applications, including temperature, humidity, pressure, and other physical parameters.

DiaSorin’s Liaison IGF-1 assay is a solution for full automation of growth factor testing on a random-access analyzer, for accurately monitoring growth dysfunctions. The company offers an extensive menu of reliable, fully automated chemiluminescent assays suitable for endocrinology clinics, reference laboratories, hospitals, and physician office laboratories. Patients benefit from rapid and accurate results, and laboratories benefit from fast turnaround time and ease of use with the Liaison assay product portfolio.

Hoefer’s new Web site was designed to create a more positive experience with improved navigation, more product information, an enhanced storefront, and more technical literature available to download. A dealer portal section has also been added to improve the communication of support materials with channel partners. The site was designed to resize to device-display resolution, enabling a better experience for desktops, tablets, and mobile devices.

SeraCare Life Sciences offers three new Accuvert seroconversion panels and one new Accuset performance panel. The new Accuvert seroconversion panels are HCV seroconversion panel PHV924, providing undiluted plasma samples from a single male donor of genotype 2b, drawn over an 88-day period in 2008; HCV seroconversion panel PHV925, providing undiluted plasma samples from a single male donor of genotype 1a, drawn over a 27-day period in 2008; and HCV seroconversion panel PHV926, providing undiluted plasma samples from a single male donor of genotype 3a, drawn over a 14-day period in 2009.

Last year, Semrock opened a high-capacity manufacturing facility for its optical filter products. Having entered full-scale production, the company now supports its OEM customers by producing spectrally complex, hard-coated sputtered optical filters with high-volume pricing. Semrock’s products are available to the emerging diagnostic and point-of-care health care and display and sensing markets, where high-performance, miniaturized optical filters are an enabling technology.

Qiagen announced two agreements that add biomarkers involving glioblastoma, lymphoma, and other cancers to the company’s portfolio of potential companion diagnostics. In the glioblastoma project, Qiagen has entered into an exclusive worldwide licensing option with Columbia University in New York on FGFR-TACC fusion genes. Qiagen intends to develop this biomarker into a test for routine use in diagnostic workups, which may allow doctors to identify glioblastoma patients who could benefit from targeted treatments.

Aviir Inc. is increasing its offered services with a comprehensive inherited cardiovascular disease genetic test menu. The newly validated tests cover the major causes of cardiomyopathies, arrhythmia disorders, and other genetically transmitted diseases that affect the heart and vasculature. Each test is available for individual and familial settings. Two comprehensive panels are available to check for undiagnosed arrhythmia or cardiomyopathy.

Biosearch Technologies has acquired the oligonucleotide manufacturing division of Danish company DNA Technology and the German CPG manufacturer VitraBio. With the acquisition of DNA Technology, Biosearch adds a skilled production team with a mature quality system and an established European customer base focused in the Nordic countries.

Hamilton Robotics has collaborated with Macherey-Nagel to create the Genomic Starlet automated liquid handling workstation. The system extracts nucleic acids from biological samples and purifies PCR products in a non-IVD environment.

Chembio Diagnostics has commenced CLIA waiver studies for its DPP HIV 1/2 assay. In December 2012, Chembio received FDA approval for its DPP HIV 1/2 assay, which detects antibodies to HIV 1/2 in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples.

Through a partnership with Illumina, Beckman Coulter Life Sciences will develop, distribute, and support automation for Illumina’s TruSeq and Nextera next-gen sequencing sample preparation kits. Illumina will provide technical expertise on chemistry and protocols.

Abbott has introduced a new capability for its RealTime m2000 system to enhance the system’s flexibility and make molecular testing easier and more efficient. Abbott’s mPlus makes it possible for laboratories to perform molecular diagnostic tests for infectious disease detection and therapy monitoring.

DiaSorin has received FDA clearance for its Liaison aldosterone immunoassay, which is intended for the quantitative determination of aldosterone in human serum, EDTA plasma, and urine samples. The test is used primarily for the diagnosis of hypertension.

Applied Spectral Imaging and WaveSense have entered into an agreement in which both companies will engage in combined sales and marketing of ASI’s GenASIs imaging and analysis instrument and WaveSense’s EpiSep cell recovery and enrichment solution. The combined solution provides an integrated cell capturing solution and computerized instrument to detect, image, and analyze the captured cells.

Abbott announced CE Marking for its Architect clinical chemistry hemoglobin A1c (HbA1c) test, which may aid physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes.

Crescendo Bioscience announced that the Wadsworth Center at the New York Department of Health, through its Clinical Laboratory Evaluation Program, issued a laboratory permit to Crescendo Bioscience to provide services to physicians in New York. Crescendo offers Vectra DA, a multi-biomarker blood test that measures disease activity in rheumatoid arthritis by integrating 12 key proteins consistently associated with the biology ...

Audit MicroControls has added to its line of calibration verification/linearity products, the beta-hydroxybutyric acid linearity, five levels. The control is intended to simulate human patient serum samples for determining linearity, calibration verification, and verification of reportable range for beta-hydroxybutyric acid. Packaged as 5 × 1 mL, this liquid product has a shelf life of two years and an open-vial stability ...

The FDA has approved Roche Diagnostics’ Tarceva (erlotinib) tablets for the initial treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR)-activating mutations as detected by an FDA-approved test. The FDA also approved Roche’s Cobas EGFR mutation test. In the United States, Tarceva is already approved, irrespective of histology or biomarker ...

Boulder Diagnostics has launched in Europe its ParaFlor kits for the detection of Giardia, Cryptosporidium, and Blastocystis infections for human and veterinary applications. The rapid assays enable detection in less than 10 minutes in fresh and fixed stool samples. They are also available for veterinary applications and research use only in humans in the United States. The ParaFlor B kit ...

ScopeLED, a division of Dicon Fiberoptics, has released its LED-based fluorescence microscope illuminator, which is designed to fit most clinical fluorescence microscopes. The ScopeLED F-series illuminators mount directly to the microscope’s fluorescence illuminator and look like a standard microscope lamp house. With more than 30,000 hours of LED lifetime, no maintenance should be required for over 12 to 15 years ...

Siemens Healthcare Diagnostics has obtained FDA clearance for its anti-cyclic citrullinated peptide (anti-CCP) IgG assay to aid diagnosis of rheumatoid arthritis (RA). Available on the company’s Immulite 2000/2000 XPi immunoassay systems, the assay enables laboratories to integrate RA testing onto an automated, random-access analyzer. With a clinical specificity of 97 percent, the Immulite anti-CCP IgG assay is a highly accurate ...

TriLink BioTechnologies has signed a licensing agreement with QuantiBact to offer twisted intercalating nucleic acid (TINA) modified oligonucleotides. TINA molecules are intercalators placed at the 5’ end of primers to stabilize duplex formation. Their properties improve the sensitivity and specificity of endpoint and real-time PCR. TINA oligos may find applications wherever an enhanced Tm is required, such as triplex formation ...

Biocare Medical’s uroplakin II mouse monoclonal antibody (IVD) is now available. Studies have shown UP II mRNA to be expressed in bladder cancer tissues and the peripheral blood of patients with primary and metastatic urothelial carcinoma. Pathologists have used uroplakin III [AU1] to establish urothelial origin of the bladder; however, use of UP III is limited owing to its poor ...

Cepheid has received FDA clearance to market its Xpert MRSA/SA blood culture test, which runs on its GeneXpert system, for the detection of methicillin-resistant Staphylococcus aureus and S. aureus in blood culture bottles showing gram-positive cocci in clusters in about one hour. Cepheid’s updated Xpert MRSA/SA BC test processes positive blood culture specimens to determine whether a patient’s blood is infected ...

The College of American Pathologists has renewed CAP 15189 Accreditation for National Jewish Health Advanced Diagnostic Laboratories. The accreditation, based on standard 15189 for laboratory technical competence and continual quality management, is administered by the International Organization for Standardization and seeks to improve patient safety and reduce risk, by outlining standards for quality and competence in medical laboratories. CAP 15189 ...

MikroScan Technologies’ Live-Q telepathology tool works as an add-on to the company’s D2 desktop whole slide scanner, which enhances remote viewing and remote control of the device. Keith J. Kaplan, MD, surgical pathologist and producer of the Digital Pathology Blog, recently tested the Live-Q user experience in a café over a standard typical Wi-Fi connection. He wrote in his review, ...

Beckman Coulter has received FDA 510(k) clearance for its Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system. In accordance with FDA requirements, the company conducted a large multicenter prospective clinical trial on the AccuTnI+3 troponin I assay that enrolled more than 1,900 subjects, and confirmed that the assay provides the clinical performance necessary for optimal ...

Bio SB offers a portfolio of more than 130 rabbit monoclonal antibodies. “Rabbit monoclonal antibodies offer higher sensitivity and specificity when compared to mouse monoclonal antibodies traditionally used in laboratory applications,” Alfonso Heras, president and CEO of Bio SB, said in a statement. “Coupled with our new line of detection systems and chromogens, such as our PolyDetector HRP Plus, PolyDetector AP, and HRP Green, Bio SB can offer a large array of immunohistochemistry products to pathologists around the world.”

Beckman Coulter’s UniCel DxH 600 Coulter cellular analysis system is a benchtop hematology analyzer for mid- to high-volume laboratories. The system provides laboratories with exceptional quality results, improved first-pass accuracy, and automatic rerun and reflex testing, thereby reducing overall manual review rates and processes.

Leica Microsystems and Bausch and Lomb announced that Bausch and Lomb will distribute Leica’s ophthalmic surgical microscopes and accessories in select markets across Europe, the United States, India, and Latin America.

Abbott has launched its Accelerator a3600 next-generation automation solution, which helps laboratories process tests faster while handling increased volume. The Accelerator a3600 processes up to 3,600 samples per hour and handles multiple tube sizes and types simultaneously.

Luminex has received FDA clearance for its Magpix instrument with the xTAG gastrointestinal pathogen panel (xTAG GPP). This is the first clinical assay to be cleared on Magpix. xTAG GPP simultaneously detects 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.

Sekisui Diagnostics’ OSOM rapid immunochemical fecal occult blood test detects hemoglobin in stool samples as an aid in the early detection of colorectal cancer. The OSOM test provides sample stability: a unique “dry-sample” collection card; value: two patient sample collections on one collection card allow compliance with screening guidelines, using only one test cassette; and a comprehensive physician and patient support Web site.

Working in conjunction with Arotec Diagnostics, The Binding Site offers myeloperoxidase (pANCA) antigen. Antibodies to myeloperoxidase have been observed in systemic vasculitis, glomerulonephritis, rheumatoid arthritis, and inflammatory bowel disease. Elevated plasma levels also have been reported in acute coronary syndromes and with some malignancies.

American Esoteric Laboratories (AEL) has expanded its test offerings for women, with the addition of its Trichomonas amplified probe test, and improved its high-risk HPV testing capabilities.

BioTheranostics’ Prostate Cancer Index is a strong predictor of prostate cancer recurrence and may improve upon the current standard of care for assessing risk of recurrence and metastasis in patients with prostate cancer, according to a study published online in the Proceedings of the National Academy of Sciences (doi:10.1073/pnas.1215870110. Epub March 26, 2013).

BD Diagnostics in April announced an international distributor agreement with Bruker Daltonics to sell and provide frontline technical support for the co-labeled BD Bruker MALDI Biotyper system. The system, combined with automated antimicrobial susceptibility testing on the BD Phoenix microbiology system and BD EpiCenter microbiology data management system, will facilitate a fully integrated, optimized approach for laboratory workflow.

Streck’s CD-Chex CD117 is a flow cytometry control for CD117. The control eliminates the need for laboratories to hold and validate patient samples to use as a control for CD117, saving time and money. CD-Chex CD117 is designed to represent abnormal peripheral blood leukocytes similar to a hematolymphoid neoplastic patient sample. The product has surface CD117 that is detectable with fluorescent monoclonal antibodies by flow cytometry. The CD117 positive abnormal leukocytes are distinguishable from normal leukocytes on the basis of light-scatter properties, a low level of CD45 expression, and heterogeneous CD117 expression.

BioFire Diagnostics has submitted to the FDA its FilmArray blood culture identification (BCID) panel. The panel received the CE Mark earlier this month. The submission comes after completion of clinical trials for the FilmArray BCID panel, which provides automatic results for common infectious causes of sepsis. BioFire anticipates commercial release of the panel this summer, pending FDA clearance.

Randox Toxicology has developed an ELISA that targets UR-144, XLR-11, and additional synthetic cannabinoid compounds, which are commonly found in new “Spice” and “K2” blends. Together with the company’s JWH/AM2201 synthetic cannabinoids ELISA, the UR-144/XLR-11 ELISA provides a comprehensive solution for the rapid detection of more than 55 current synthetic cannabinoids in urine, blood, and oral fluid.

The Center for Phlebotomy Education is holding the Phlebotomy Supervisor’s Boot Camp July 10-12 and Nov. 6-8 in Louisville, Ky. Educators, phlebotomy supervisors, and lab managers who attend will acquire new skills and strategies for staff development, technical instruction, mentoring, and coaching professionalism. The presenters are Catherine Ernst, RN, PBT(ASCP), Lisa Steinam, PBT(ASCP), and Dennis Ernst, MT(ASCP).

With a recent software upgrade (V2.5/2.3.0.0) and new adapter for its Clinitek Status Connect urine chemistry system, Siemens Healthcare Diagnostics now offers hospitals and clinicians seamless wireless connectivity and improved bar-coding capabilities for point-of-care urinalysis testing. These enhancements enable greater flexibility, risk management, and speed.

Eppendorf North America’s Mastercycler Nexus X1 provides researchers with increased heating and cooling rates by uniting the software with a fast 96-well block. All this is achieved while maintaining low power consumption and low noise emission levels, making the instrument suitable for life science laboratories.

Audit MicroControls’ MicroLQ serum protein control, two levels, is intended to simulate human patient serum samples to monitor the precision of laboratory testing procedures for albumin, alpha1-acid glycoprotein, alpha1-antitrypsin, alpha2-macroglobulin, antithrombin, beta2 microglobulin, ceruloplasmin, complement C3, complement C4, haptoglobin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin M, prealbumin, total protein, and transferrin.

Pathwork Diagnostics has entered into an agreement with Kindstar Global to provide Kindstar with the FDA-cleared IVD kit version of the Pathwork Tissue of Origin Test. The agreement expands Pathwork’s international network of test and service providers and is the first IVD kit agreement for Pathwork.

CellaVision’s proficiency software is for clinical laboratories that assess and perform the classification of blood cells and accredited providers of external quality assessment schemes for laboratory medicine. With the software, medical technologists can train and test their skills in performing peripheral blood and body fluid differential counts and get instant feedback on their performance.

BioFire Diagnostics announced that the U.S. Patent and Trademark Office has issued U.S. patent No. 8,394,608 covering the company’s FilmArray system. This is the first U.S. patent issued to cover the FilmArray system, and BioFire has exclusive rights to the patented technology. The patent specifically covers methods for sample preparation and two-step multiplex polymerase chain reaction in a sealed container.

Hardy Diagnostics’ Val media-fill challenge kits are for USP 797 compliance testing for compounding-sterile preparations (CSPs). The ready-to-use media-fill challenge kits are for use in validating pharmacy compounding personnel in accordance with USP 797 guidelines. Aseptic media-fill testing is part of an effective quality assurance program to ensure pharmaceutical processes and personnel produce sterile products that are free of microbial contaminants.

Randox Laboratories’ Acusera liquid BNP control is for use in the routine monitoring of accuracy and precision. Assayed instrument-specific target values and ranges are provided for Beckman Access, Abbott Architect, and Siemens Advia Centaur instruments. The BNP control is a 100 percent human serum, manufactured to the high-quality standards associated with all Acusera controls.

Life Technologies has signed a collaborative research agreement and related license with Harvard University under which Life Tech has acquired exclusive rights to develop a panel of characterization assays to rapidly evaluate human pluripotent stem cells for their utility in discovery and translational research applications.

Diagnovus has launched Engauge-cancer-DLBCL, a commercial gene-expression assay for risk stratification and treatment of patients with diffuse large B-cell lymphoma. “Engauge-cancer-DLBCL, which combines a patient’s IPI [International Prognostic Index] score and the results of the gene-expression assay, can more accurately predict outcomes for patients than IPI alone in order to optimize treatment choices for patients,” Ron Levy, MD, leader of the Lymphoma Program at Stanford University School of Medicine, said in a statement.

NanoString Technologies has launched its first commercial IVD product, the Prosigna breast cancer prognostic gene signature assay for the nCounter diagnostic system, in the European Union and Israel. Based on the PAM50 gene signature initially discovered by Charles Perou, PhD, and colleagues, the Prosigna assay provides a subtype classification based on the biology of an individual’s breast tumor (intrinsic subtyping), and a prognostic score (risk of recurrence, or ROR, score).

SeraCare Life Sciences has launched three seroconversion panels that provide difficult-to-find patient samples for hepatitis B and HIV. HBV seroconversion panel PHM938 comprises six undiluted plasma samples from a single donor drawn over a six-day period and is HBV DNA-positive from the first bleed.

Randox Toxicology offers three new ELISA testing kits for the detection of sedative drugs zopiclone, zaleplon, and zolpidem, which behave similarly to benzodiazepines. Randox developed the ELISA kits for the detection of these drugs in urine and blood specimens. The zolpidem ELISA offers a limit of detection of 0.4 ng/mL in urine and 0.52 ng/mL in blood.

Dako has received FDA clearance to sell its Flex monoclonal rabbit anti-human estrogen receptor alpha, clone EP1 in the United States. The clone has been available in Europe for some time. With this diagnostic tool, breast cancer patients can be confident they are receiving effective treatment for their particular type of breast cancer.

Carl Zeiss Microscopy’s Axio Lab.A1 microscope is available for use in polarization microscopy. It is suitable for student education and routine laboratory requirements. This upright microscope suits colleges and universities, research institutes in the geosciences and mineralogy fields, and in the oil exploration industry.

Hamilton Robotics’ PCR setup Starlet automated liquid-handling system can accommodate any DNA amplification reagent kit, from simple setups and small budgets to highly demanding workflows. The workstation is suitable for gene expression, genotyping, sequencing, or mutagenesis. It was developed for different PCR types, such as endpoint-, q-, multiplex, or linear PCR.

CellaVision and Beckman Coulter have added Europe, the Middle East, and Africa to their global distribution agreement. The agreement gives Beckman Coulter a nonexclusive right to sell CellaVision’s products in hematology laboratories worldwide, except in Canada and Japan. Beckman and CellaVision have been developing their partnership since 2010, when they partnered in the United States, Latin America, and Asia-Pacific, including in China and India.

Thermo Fisher Scientific’s iCAP 7000 series ICP-OES (inductively coupled plasma optical emission spectrometer) is driven by Qtegra Intelligent Scientific Data Solution (ISDS) software. The platform, designed to streamline workflows and minimize cost per sample, facilitates trace elemental analysis in pharmaceutical, environmental, industrial, and food and beverage analysis applications.

Hardy Diagnostics’ parasite suspensions are designed for a variety of parasitology applications to provide reliable and consistent quality control results. The suspensions are microorganism preparations designed to mimic patient samples to support quality assurance programs in documenting process and detection proficiency. The suspensions can be used in the QC or validation of diagnostic test kits and methods, in microscopic examinations, in staining procedures, in proficiency testing, and for teaching purposes in educational settings.

Abbott has introduced in the European Union and other areas outside of the United States a molecular diagnostic test for the detection of influenza A/B and RSV (respiratory syncytial virus). The IMDx flu A/B and RSV assay, developed by Intelligent Medical Devices for Abbott’s m2000 molecular diagnostics analyzer, is performed on nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. It is a qualitative, reverse-transcription polymerase chain reaction test for rapid detection of influenza A/B and RSV.

SciGene and BioDot have entered into an agreement whereby BioDot would have exclusive rights to market and sell SciGene’s Little Dipper Processor for fluorescence in situ hybridization to cytogenetic labs worldwide. The instrument automates tissue and cell sample processing for a variety of cytogenetic tests. Terms of the deal were not disclosed.

Athena Diagnostics offers new genetic tests to aid in the detection of several rare neurological disorders, including hereditary neuropathy, neuromuscular disease, epilepsy, and certain movement disorders. The lab-developed tests are available through Athena, a business of Quest Diagnostics.

Illumina’s TruSight Tumor, for NGS-based somatic variant detection in solid tumors, provides optimized amplicon-based library preparation of 26 oncogenes and tumor suppressor genes selected for their involvement in common solid tumors, including lung, colon, melanoma, gastric, and ovarian cancer.

Bio SB, through its partnership with ZytoVision of Germany, can now distribute a complete line of CE-approved chromogenic in situ hybridization and fluorescent in situ hybridization probes targeted for use in lung carcinomas. The line of lung carcinoma CISH and FISH probes includes ZytoLight ALK/EML4 Tricheck triple-color probe (Z-2144-200), ZytoDot EGFR/CEN7 dual-color probe (C-3033-400), and many more.

Biotix’s Tip Eject is a pipette tip reloading system that allows users to reload to Biotix racks without transfer devices. The packaging is translucent, which allows for easy tip identification while fully protecting tips from contamination due to contact and environmental particulates. Tip Eject cards are made from 100 percent recycled polypropylene, which helps labs reduce waste without sacrificing the quality of pipette tips.

Thermo Fisher Scientific’s Dionex UltiMate 3000 biocompatible rapid separation liquid chromatography system is designed to combine ultrahigh-performance liquid chromatography with the corrosion-resistant flow path required to analyze proteins, peptides, nucleic acids, and biotherapeutics.

NorDx, a member of MaineHealth, is the nation’s first clinical laboratory to acquire Sysmex America’s XN series automated hematology analyzers. The Sysmex XN-3000 configuration enables enhanced diagnostic capabilities and greater efficiency, which transforms NorDx into an accountable care laboratory model and shepherds in a new era of performance standards for quality care in New England, according to Stan Schofield, president of NorDx and senior VP of MaineHealth.

Tanner Scientific’s TN1500 tissue-embedding center is a user-friendly workstation that was designed with the input of hundreds of histology lab supervisors. The workstation features a four-line digital display for easy programming (all surface temperatures can be viewed and adjusted without the need to scroll), a fully adjustable cryoplate that can be placed on the right or left side, an adjustable-intensity bright LED light on a flexible tube, a 2.6-gallon tank capacity, an extra-large magnifying glass on a flexible tube, and more.

Medical’s highly specific p40 mouse monoclonal anti-p40 [BC28] demonstrated similar sensitivity and specificity to the company’s rabbit polyclonal p40, staining 97 percent (65/67) of cases of lung squamous cell carcinoma and zero percent (0/71) cases of lung adenocarcinoma, in an in-house study. In addition, the antibody has significantly less background and does not stain macrophages.

MolecularMD Corp. has entered into a license agreement to obtain rights to commercialize patent-pending intellectual property pertaining to use of LKB1 for diagnostic, prognostic, and predictive uses in humans in non-small cell lung cancer.

The African Society of Laboratory Medicine, working in conjunction with the CDC, Clinton Health Access Initiative, UNAIDS, and WHO/AFRO, has partnered with SoftTech Health in a program to network the laboratories continentwide with the LabQMS (Quality Management Software).

Eppendorf North America and the journal Science are now accepting applications for the 2013 Eppendorf and Science Prize for Neurobiology—an annual international research prize of $25,000. The prize is awarded to one young scientist for his or her outstanding contributions to neurobiology research. Researchers 35 years old or younger are invited to apply by June 15.

Roche and Hamilton Robotics have introduced an integrated platform that enables automated DNA sample enrichment for Roche’s 454 GS Junior sequencer. The platform builds on the integration of Roche’s REM e system with Hamilton’s Microlab Nimbus NGS workstation, resulting in reduced hands-on time, minimized operational variability, and more consistent results.

Evogen has entered into a nonexclusive license agreement with Focus Diagnostics granting worldwide rights to incorporate Evogen HyBeacons PCR probe technology into Focus Diagnostics’ molecular diagnostic products and services.

SciGene Corp.’s Hyb-Ice thermal profiling system performs everyday temperature profiles. The system consists of a programmable heating/cooling base and removable block that heat and cool samples from 4° to 99°C. It accommodates a variety of quick-change blocks to fit nearly any tube or plate.

Quality Laboratory Solutions has added to its LinChek product line of calibration verification/linearity material a chemistry linearity test set. The new test set is a liquid product packaged as six distinct levels with three ampules of 1 mL for each level. Twenty-five different analytes, including the most-requested tests, are included. An 18-month supply of product is available with each test set by providing three separate sets of linearity material.

Hamilton Robotics announced that the CytoScan automated target preparation solution from Affymetrix is built on Hamilton’s customizable Microlab Nimbus 96 workstation. The Nimbus 96 instrument automates target preparation for the CytoScan cytogenetics solution, which offers broad coverage for detecting human chromosomal aberrations.

Streck’s CVA, an assayed linearity control kit used to determine the patient reportable range of three- and five-part hematology instruments, is now assayed for Beckman Coulter’s UniCel DxH 800. CVA establishes an instrument’s reportable range and verifies linearity, testing the instrument’s extreme upper and lower limits, ensuring that patient results are valid.

Nanosphere has obtained the CE-IVD Mark for its gram-negative blood culture test (BC-GN) on the automated sample-to-result Verigene system. The test expands Nanosphere’s infectious disease test capabilities to include rapid detection of bacteria that can cause deadly bloodstream infections.

Oncomatrix’s DMTXinvaScan is an immunohistochemistry-based kit designed to diagnose and predict the invasiveness of pancreas, breast, lung, colon, and head and neck tumors. The main component of DMTXinva-Scan is a monoclonal antibody that detects collagen XI-α1. Oncomatrix developed and clinically validated this antibody.

Biosearch Technologies has acquired exclusive worldwide rights to continuing Stellaris RNA FISH-based inventions from the University of Medicine and Dentistry of New Jersey. In addition to single-molecule detection of mRNA, lncRNA, and viral RNAs, Stellaris-based methods have been extended to directly and quantitatively detect chromosomal diseases caused by translocations and aberrant splice junctions and single-nucleotide polymorphisms.

Meridian Bioscience’s Illumigene group A Streptococcus and group B Streptococcus tests have been recategorized under CLIA as moderate complexity. The new categorization of these tests allows the Illumigene platform to be available to all moderate-complexity labs in U.S. hospitals and clinics, allowing them to offer an accurate, rapid, simple molecular test for each of these pathogens.

Audit MicroControls’ MicroFD urine chemistry control, two levels, is intended to simulate human patient samples for monitoring the precision of laboratory testing procedures for urine chemistry assays, including amylase, calcium, chloride, creatinine, glucose, magnesium, microalbumin, microprotein, phosphorous, potassium, sodium, urea nitrogen, and uric acid.

Quest Diagnostics offers a clinical test panel for aiding the diagnosis of suspected dementia due to treatable forms of cognitive impairment. The panel is believed to be the first commercial service from a clinical laboratory to combine several guideline-recommended tests for identifying secondary, treatable causes of dementia as a single blood test and report.

Randox Laboratories’ www.riqas.com allows users to discover the benefits offered by the Randox International Quality Assessment Scheme (RIQAS) and the advantages of implementing external quality assessment (EQA). The Web site displays information on well-designed, easy-to-navigate pages.

Bio/Data Corp.’s Collagen synthetic reactive peptide (SRP) is a synthetic type-1 collagen-like liquid polypeptide that self-assembles into a helix to form fibrils. Synthetic collagen may be useful in laboratories investigating platelet function and reactivity, platelet activation, and cellular analysis.

Qiagen offers a sample-to-result next-gen sequencing workflow designed to enable the routine use of NGS technology in areas such as clinical research and diagnostics. Qiagen’s NGS workflow is an ecosystem of products and services that offer automated processes from primary sample to digital result.

Eppendorf North America’s µCuvette G1.0 is for measuring small volumes of highly concentrated biomolecules, such as proteins and nucleic acids. Users can work easily with samples as small as 1.5 μL, without the need for a time-consuming dilution step. The μCuvette G1.0 expands the measuring range of the Eppendorf BioPhotometer and BioSpectrometer.

Roche has received FDA approval for its Cobas AmpliPrep/Cobas TaqMan HCV test, v2.0. The next-generation viral load test is for use in the management of patients with chronic hepatitis C virus infection. The test provides a novel dual-probe approach, for an extra layer of protection in detecting and quantifying the virus and is designed to accurately determine the amount of HCV RNA to assess a patient’s response to antiviral therapy.

Agilent Technologies’ SureSelect strand-specific RNA library preparation kit for whole transcriptome and targeted RNA sequencing allows researchers to prepare high-quality, strand-specific libraries for next-generation sequencing. The ability to gain strand-specific information from RNA sequencing experiments allows researchers to more easily discern overlapping transcripts and investigate antisense expression to better understand gene regulation.

Cerilliant offers certified spiking solutions for use in preparing T4-13C6, T3-13C6, and reverse T3-13C6 calibrators and controls for monitoring free and total thyroid hormone levels in serum or plasma by liquid chromatography-tandem mass spectrometry. These products offer clinical and endocrinology labs the full range of stable-labeled internal standards necessary for accurate quantitation of T4, T3, and reverse T3, using LC-MS/MS.

Vector Laboratories now offers its ImmPress polymer detection reagents with alkaline phosphatase as the enzyme detection system. Available as anti-mouse and anti-rabbit ImmPress-AP alkaline-phosphatase polymer reagents, these products are designed to detect primary antibodies made in rabbit and mouse in immunohistochemical staining. They provide greater sensitivity than conventional alkaline-phosphatase antibody conjugates and other alkaline-phosphatase detection reagents.

BioFire Diagnostics has received FDA clearance for its updated Film-Array respiratory panel. The purpose of the updated panel is to improve the detection of adenovirus. Studies performed to support the clearance of the modified panel demonstrated a 73 percent increase in the detection of adenovirus and a threefold improvement in the limit of detection when compared with the original panel.

PathCentral’s Pathology Network, www.pathcentralpro.net, is a comprehensive online information exchange and digital consultation forum. The network allows physicians to upload case files using digital images for pathologists to review and render critical consulting diagnoses on a global and a domestic real-time basis. The network seeks to connect pathologists by incorporating social media tools, making the forum ideal for pathologists to send and perform consultations, post information, share cases, ask questions, and expand professional relationships.

QualityStar will present at the Cambridge Healthtech Institute’s Ninth Annual Biomarkers and Diagnostics World Congress a new application that uses whole-slide digital imaging (WSI) for anatomic pathology external peer review quality assurance. The presentation will review current quality assurance programs and the application of WSI as an approach to gain longitudinal benchmarking data for quality review.

Quidel has received FDA 510(k) clearance for its Molecular RSV and hMPV assay for the detection of respiratory syncytial virus and human metapneumovirus. The assay distinguishes between RSV and hMPV. The RSV and hMPV assay can be batched alongside other Quidel Molecular assays, such as the influenza A and B PCR assay, in the same multiwell panel for customized multiplexing capability.

Agilent Technologies’ HaloPlex exome kits and SureCall software complement the company’s Web-based SureDesign interface and custom HaloPlex gene panels to provide a complete, integrated workflow. The HaloPlex exome kit comprises about 2.5 million probes to provide comprehensive coverage of the coding regions of the human genome with minimal hands-on time. The kit requires only 200 ng of input DNA.

Advanced Cell Diagnostics has entered into an agreement with Johns Hopkins University on behalf of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, whereby ACD’s RNAscope technology will be used to validate novel biomarkers and drug targets for cancer immunotherapy.

Dako’s Omnis solution, a new addition to the company’s immunohistochemistry portfolio, consists of hardware, software, and reagents. It automates IHC and ISH processes, allowing entire patient cases to be processed simultaneously. The solution offers continuous loading, batch loading, and overnight run options. Its state-of-the-art software allows slide processing and instrument maintenance to be traced to individual operators, greatly increasing quality control.

Epigenomics has submitted to the FDA the fourth and final module of its premarket approval for its blood-based Epi proColon test for the detection of colorectal cancer.

PerkinElmer’s Ivis Lumina series III benchtop platform is for oncology, infectious disease, and drug discovery and efficacy research. The system integrates bioluminescence and full spectral fluorescence in vivo imaging technologies, providing an expandable and sensitive benchtop imaging platform.

Sarstedt’s Minivette POCT is a device for the precise and hygienic collection, transfer, and subsequent dispensing of small capillary blood samples for point-of-care tests.

Thermo Fisher Scientific’s Syncronis high-performance liquid chromatography columns are now available with 3-mm particle size. The new size complements the existing 1.7- and 5-µm particle sizes.

Horizon Discovery was named the most promising company at the Personalized Medicine World Conference 2013. Horizon was chosen from 32 shortlisted companies based on technology, historical performance of the company, and forward business plans.

Diagnostic BioSystems’ PermaYellow/horseradish peroxidase (HRP) is a substrate-chromogen system designed for immunohistochemistry or in situ hybridization when using horseradish peroxidase. PermaYellow/HRP produces a distinct bright yellow color that can be distinguished easily from other stains.

Akonni Biosystems has extended its family of smart-tip extraction products for rapidly purifying human genomic deoxyribonucleic acid (gDNA) on Hamilton’s Microlab Star robotic liquid-handling workstations.

Used in conjunction with Alpha-Tec Systems’ NAC-PAC (N-acetylcysteinepackage ) line of digestion/ decontamination, buffering, and resuspension reagents, Alpha-Tec’s five percent oxalic acid is recommended to optimize decontamination conditions of specimens with P. aeruginosa.

Dako, an Agilent Technologies company, has entered into a master framework agreement with Eli Lilly and Company for the development of companion diagnostic tests to identify patients who may be more likely to benefit from an investigational oncology medicine currently under development by Lilly.

Mycology Benchtop Reference Guide is an illustrated guide to common fungi. Included are full-color colony and microscopic views. The guide provides a convenient way for students and medical technologists to quickly and confidently identify fungi.

Qiagen announced three separate agreements that add biomarkers to its diagnostic pipeline for personalized health care applications to guide treatments with various medicines based on a patient’s genomic information.

PerkinElmer and Verinata Health announced a strategic agreement for expanding access to Verinata’s Verifi test, a comprehensive noninvasive prenatal test (NIPT) for high-risk pregnancies. The Verifi test, performed at Verinata’s CLIA-certified California laboratory, uses a single maternal blood draw at as early as 10 weeks of pregnancy to detect multiple fetal chromosomal aneuploidies. Under terms of the collaboration, PerkinElmer will serve as an exclusive Verinata partner in joint sales and marketing of the Verifi test.

Leiden University Medical Center and Inova Diagnostics have completed a worldwide license agreement for technology developed at LUMC to detect antibodies to carbamylated proteins (anti-CarP). This technology represents an important advance in diagnosing rheumatoid arthritis (RA).

Vector Laboratories has added to its mouse-on-mouse (MOM) family of detection reagents the MOM ImmPress peroxidase polymer kit. It allows the use of mouse primary antibodies on mouse tissue without background staining, by using a sensitive, one-step, non-biotin MOM ImmPress polymer reagent. The reagent also provides a time savings in the detection protocol, since it is ready to use in one step.

MidSci’s Bio-Assembler kits use magnetic levitation to culture cells in three dimensions. Available in single-, six-, and 24-well configurations, the kits supply magnetic drivers, low-binding dishes/ plates, and Nanoshuttle-PL solution in quantities and volumes appropriate to kit size.

Sarstedt’s S-Monovette is an enclosed multiple-sampling blood collection system. All tubes are plastic and have screw caps, which minimizes the risk of breakage and aerosol formation when caps are removed. The screw caps have a thin, recessed membrane that is easy to puncture and protects users from residual blood droplets.

Trovagene expects to achieve analytical and clinical validation of its urine-based HPV carrier screening test this month in its CLIA laboratory. When validation is complete, the test will be available to clinicians and their patients.

Selventa’s Systems Diagnostics, or SysDx, will be a novel class of diagnostic tests that consist of “multi-omic” biomarkers selected through analysis of a patient’s biological profile, including genomic, epigenomic, transcriptomic, proteomic, metabolomic, and electronic medical record information. From the data, Selventa will generate a differentiated and clinically relevant report that physicians and patients can use to improve therapy selection.

Hardy Diagnostics’ Arcanobacterium selective agar is a selective medium for the isolation of Arcanobacterium haemolyticum, especially from respiratory specimens.

Spot Imaging Solutions’ ultrasensitive Spot Pursuit USB digital camera combines superb image quality with excellent temporal resolution for rapid time-lapse recordings. This enables researchers to document live cells and photobleaching fluorescence specimens easily.

Thermo Fisher Scientific has expanded its suite of cryopreservation reagents with the HyClone HyCryo and HyCryo-Stem cryopreservation media, enabling researchers to maximize the preservation, recovery, and growth of post-thaw cells for general cell culture and stem-cell applications.

Alpha-Tec Systems’ NAC-PAC (Nacetylcysteine-package) EA3 offers a complete specimen preparation reagent system to digest, buffer, and resuspend patient samples for lab analysis of Mycobacterium spp. The reagents in NAC-PAC EA3 improve the efficiency of acid-fast bacilli diagnostics and reduce the need to reprocess samples by controlling pH throughout the entire specimen preparation procedure with an integrated pH indicator to ensure a neutral patient sample is achieved.

Dako recently introduced in the United States its instant quality in situ hybridization, or IQISH, technology, which will reduce the turnaround time for cancer evaluation from two days to three and a half hours. HER2 IQFISH PharmDx, a fluorescence in situ hybridization assay, is the first product approved by the FDA that uses IQISH technology, which is based on the company’s fast IQISH hybridization buffer chemistry.

March 2013—Great Basin Corp., a privately held molecular diagnostics company that develops sample-to-result solutions, has raised $9.5 million in series B funding. The funding was led by private investors and will be used to expand manufacturing, fund research and development, and expand global commercialization efforts.

Tosoh Bioscience’s ST AIA-Pack 25-OH vitamin D assay is for use on most of the company’s AIA system analyzers. Vitamin D measurement is intended as an aid in the determination of vitamin D sufficiency.

Streck’s A1c-Cellular HbA1c control with intact red blood cells is now assayed for Roche Diagnostics’ Cobas c311. A1c-Cellular tests the entire HbA1c procedure, including the lysing of the red blood cell. This step ensures that the entire system—instrument and reagents—is working properly and providing accurate patient results. The control is easy to use; it does not require reconstitution, which reduces the potential for human error.

Eppendorf North America’s epMotion M5073 and P5073 workstations automate and simplify complex, labor-intensive pipetting tasks, saving time and improving the reliability and reproducibility of results.

Thermo Fisher Scientific’s Prelude sample preparation and liquid chromatography (SPLC) system was developed to make analysis of target compounds in complex biological matrices routine for clinical research and forensic toxicology laboratories.

Randox Laboratories’ Acusera 24.7 live online is a Web-based interlaboratory data-management program to complement Acusera third-party quality controls and improve quality control processes within the clinical laboratory, while also helping to interpret QC results.

Inova Diagnostics’ Bio-Flash rapid-response chemiluminescent analyzer is for use by clinical reference and hospital laboratories. Bio-Flash and the company’s Quanta Flash reagents are for autoimmune disease diagnostic testing.

LabCorp recently announced that its biorepository has been accredited by the College of American Pathologists.

Abbott and BioView have entered into an agreement in which BioView will develop automated digital-imaging software for use with Abbott’s molecular diagnostic test to detect rearrangements of the ALK gene in patients with advanced non-small cell lung cancer. The software scans lung tissue specimens that have been tested for the ALK gene rearrangement with Abbott’s fluorescence in situ hybridization technology.

Vector Laboratories has added to its line of Western blot detection reagents two highly active WestVision peroxidase polymer antibody conjugates.

MorphoSys in December signed a definitive agreement to sell its AbD Serotec research and diagnostic antibody segment to Bio-Rad Laboratories.

Diazyme Laboratories has received FDA 510(k) clearance to market its new 25-hydoxy vitamin D assay, which measures total true 25-hydroxy vitamin D levels in serum and plasma samples. The assay automates the removal of nonspecific protein binding and cross-reactivity that may occur in competing assays, thereby ensuring results will be precise and accurate.

BloodCenter of Wisconsin’s Diagnostic Laboratories has expanded its genetic testing menu for hemophilia. Its new approach to hemophilia genetics allows BloodCenter to identify the genetic abnormality in greater than 95 percent of all hemophilia patients.

Beckman Coulter Life Sciences has added to its flow cytometry portfolio 14 new human monoclonal antibodies from Trillium Diagnostics. The analyte-specific reagents are highly specific, convenient, and flexible. Also offered is a new cell permeabilization reagent.

Hologic has received FDA clearance to market its Aptima Trichomonas vaginalis assay on the company’s automated Panther system.

Meridian Life Science offers several new Toxoplasma gondii products.

Chembio Diagnostics reported that data from a study evaluating the sensitivity and specificity of the company’s point-of-care Dual Path Platform (DPP) rapid test for syphilis was recently published online in Clinical Infectious Diseases.

MDxHealth has joined forces with Ghent University to establish NXTGNT, a pharmacoepigenomics center.

Siemens Healthcare Diagnostics Sysmex CS-5100 system, a random-access high-volume coagulation analyzer, is now available in Europe, Africa, Canada, Latin America, Australia, and New Zealand. It is equipped with multi-wavelength preanalytical sample integrity technology, enabling high-volume laboratories to achieve first-run accuracy by identifying and managing unsuitable test specimens before analysis.

The Clinical and Laboratory Standards Institute has published “M54-APrinciples and Procedures for Detection of Fungi in Clinical Specimens-Direct Examination and Culture; Approved Guideline.” The document addresses the protocols for detecting fungi in clinical specimens and highlights direct microscopic examinations and fungal culturing methods.

Qiagen has submitted to the FDA its Therascreen EGFR RGQ PCR kit as a proposed companion diagnostic test to guide treatment with afatinib, an investigational oncology compound developed by Boehringer Ingelheim. The FDA has accepted afatinib for filing and granted it priority review as a proposed treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation detected by an FDA-approved test.

Smart Imaging Technologies’ Simagis Live Web Pathology Platform version 4.0, launched last month, makes the transition to digital pathology simple and affordable. With Simagis cloud software, pathologists can connect scanners to a private cloud server and start collaborating.

Insight Genetics has received from the National Cancer Institute two small business innovation research contracts to continue its work developing diagnostic tests that identify and characterize specific genetic mutations in lung cancer patients.

Computype, in partnership with Nautilus Systems, launched the Flexible Tube and Vial Feeder (Flex TVF), a system for automatic downstream tube and vial feeding that increases efficiency.

Chembio Diagnostics has received FDA approval to market its point-of-care Dual Path Platform (DPP) HIV 1/2 assay for the rapid detection of HIV-1/2 antibodies in oral fluid or blood samples.

Akonni Biosystems recently announced results from three preclinical studies verifying the efficacy of its TruDiagnosis molecular diagnostic platform. Akonni TruArray tests are for mid-multiplex molecular diagnostics deployed in near point-of-care settings.

Cellular Engineering Technologies and the nonprofit John Paul II Medical Research Institute (JP2MRI) are partnering to develop a private stem cell biobank. The collaboration will create more than 5,000 patient- and disease-specific stem cell lines and other human cell lines to advance drug discovery and offer personalized medicine. These cell lines are derived from adult sources and do not include embryonic stem cells.

Luminex has received FDA clearance for its xTAG gastrointestinal pathogen panel (GPP), which is a comprehensive molecular diagnostic assay that tests for greater than 90 percent of bacterial, viral, and parasitic causes of infectious gastroenteritis.

DiaSorin has received FDA clearance for its Liaison direct renin immunoassay to aid in the diagnosis and treatment of certain types of hypertension.

AvanSci Bio has expanded its product line for dissecting slide-mounted tissue sections with its 2iD Scope and 2iD Cam for digital annotation of the areas to be dissected and xScision reagents for slide deparaffinization and dissection from paraffinized tissue sections. These new products, along with the company’s existing products for slide-mounted tissue mesodissection, provide a workflow solution capable of replacing manual slide-mounted tissue dissection for most pathology applications.

Horizon Discovery has signed a research service collaboration deal with Boehringer Ingelheim to support Boehringer’s oncology programs by using Horizon’s Discovery toolbox for research projects and profiling compounds at the hit-to-lead, lead optimization, and preclinical stages to elucidate their anticancer properties and help guide drug discovery programs.

Streck’s LBC-Chex is a lamellar body count control. Lamellar bodies have been analyzed as an indirect estimate of fetal lung maturity and potential indicator of respiratory distress syndrome.

Applied Spectral Imaging recently launched its GenASIs Go-Path computer-aided membrane and nuclear immunohistochemistry imaging and analysis platform.

Meridian Bioscience has completed beta trials for two new Illumigene molecular amplification tests specifically designed to detect the DNA of Chlamydia trachoma-tis and Neisseria gonorrhoeae, respectively, from swab and urine specimens.

LipoScience has entered into a research agreement with Duke University School of Medicine to identify cardiovascular risk factors to be used alone or in combination with other clinical measures to improve stratification and management of acute coronary syndrome. The agreement encompasses studies to be performed with Duke’s CathGen (CatheterizationGenetics) and other patient registries.

Abbott has received CE-marking for its Architect Stat High-Sensitive troponin I assay. The test measures very low levels of cardiac troponin, which allows physicians to evaluate, in two to four hours, whether patients are having a heart attack.

February 2013—Bio-Rad Laboratories has released three External Quality Assurance Service (EQAS) programs for clinical laboratories and near-patient/point-of-care settings worldwide. They are cardiac markers, ethanol/ammonia, and lipids.

Copan Diagnostics has worked with infection-control and point-of-care providers to develop training videos and collection guides demonstrating proper technique for collecting respiratory specimens. Among the educational resources Copan has produced are a set of videos for the CDC and Joint Commission to be used in a Web-based course on influenza diagnosis and treatment in ambulatory settings.