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Author Archives: CAP TODAY

Qiagen ships QIAstat-Dx test kits for SARS-CoV-2

Feb. 27, 2020—Qiagen announced it has shipped its newly developed QIAstat-Dx Respiratory Panel 2019-nCoV test kit to four hospitals in China for evaluation and is in the process of shipping QIAstat-Dx testing kits to public health institutions in other regions, including Europe, Southeast Asia, and the Middle East.

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Thermo Fisher introduces Ion Torrent Genexus System

Nov. 22, 2019—Thermo Fisher Scientific launched at the Association for Molecular Pathology annual meeting the Ion Torrent Genexus System. The integrated, next-generation sequencing platform features an automated specimen to report workflow with 10 minutes hands-on time, two user touchpoints, and a turnaround time of one day.  

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FDA clears Xpert BCR-ABL Ultra

Oct. 7, 2019—Cepheid received clearance from the FDA for Xpert BCR-ABL Ultra for monitoring disease burden in patients with chronic myeloid leukemia. It is the first FDA-cleared test of its kind capable of delivering accurate molecular results from whole blood samples in under three hours, Cepheid said in an Oct. 2 release.

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Visiun awarded group purchasing agreement

Oct. 3, 2019—Visiun announced it has been awarded a group purchasing agreement from Premier. The agreement allows Premier members to take advantage of special pricing and terms prenegotiated by Premier for Visiun’s Performance Insight laboratory analytics system.

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Roche launches Cobas EBV, BKV tests on 6800/8800 systems

Sept. 30, 2019—Roche announced the commercial availability of the Cobas EBV (Epstein-Barr virus) and Cobas BKV (BK virus) tests for use on the Cobas 6800/8800 systems in countries accepting the CE mark. The tests are used to assess transplant patients' risk of developing disease by these pathogens, which can contribute to organ rejection.

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nRichDX unveils high-yield liquid biopsy sample prep platform

Sept. 26, 2019—nRichDX introduced its Revolution System, a high-yield sample prep platform designed to increase liquid biopsy–based test sensitivity by delivering more target input for molecular assays. The target yield increase is accomplished by combining the ability to process a wide range of sample volumes (3–50 mL) with recovery rates of 70–90 percent.

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FDA approves Cobas Babesia

Sept. 20, 2019–Roche received FDA approval for the Cobas Babesia test for use on the Cobas 6800 and Cobas 8800 systems. It is a qualitative in vitro nucleic acid screening test for the direct detection of babesia (B. microti, B. duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors.

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2019 CAP accreditation checklists now available

The 2019 edition of the CAP accreditation checklists are now available. Some highlights of this edition’s changes include the addition of a new checklist requirement in the chemistry checklist on opiate testing, and the addition of a new checklist requirement in the transfusion medicine checklist to align with the FDA on the labeling of red blood cells with historical antigen typing.

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Dermatopathology guide

New from Innovative Science Press is Survival Guide to Dermatopathology by Jerad M. Gardner, MD. Dr. Gardner covers many of the common entities in dermatopathology as well as some esoteric ones, particularly if they have distinct features or are of major clinical significance, in order to help the reader increase diagnostic confidence. The guide features numerous high-quality photomicrographs annotated with key findings.

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Medical informatics expert, pathologist Donald Lindberg, MD, dies

Donald A. B. Lindberg, MD, former director of the National Library of Medicine, passed away on August 17. Past member of the CAP, Dr. Lindberg graduated from Columbia University College of Physicians and Surgeons in 1958 and was a professor of information science and professor of pathology at the University of Missouri-Columbia before being named director of the NLM in 1984. Read his New York Times obituary.

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Roche launches PD-L1 assay in CE markets as CDx for TNBC

Aug. 30, 2019—Roche announced the expanded use of its Ventana PD-L1 (SP142) Assay in triple-negative breast cancer for patients living in CE markets where Tecentriq is approved. It is the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with Tecentriq (atezolizumab) plus chemotherapy (nab-paclitaxel). The announcement follows the FDA approval of the assay in March as the first companion diagnostic to identify triple-negative breast cancer patients eligible for the Tecentriq combination.

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South Bend Medical Foundation sells diagnostic lab to LabCorp

Aug. 2, 2019—South Bend Medical Foundation announced it will sell its diagnostic clinical laboratory testing assets to LabCorp. SBMF will reinvest the proceeds from the sale into the organization to further enhance and modernize facilities and procedures, ensure the ability to fund retiree pensions, and focus on its core business of pathology and blood banking services.

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FDA clears new indications for existing Lyme disease tests

Aug. 1, 2019—The U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared involve a new testing paradigm in which two enzyme immunoassays are run concurrently or sequentially, rather than the current two-step process in which a Western blot must be run after the initial EIA test.

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Exact Sciences to buy Genomic Health for $2.8 billion

July 29, 2019–Exact Sciences and Genomic Health announced today that the companies have entered into a definitive agreement in which Exact Sciences will combine with Genomic Health for $2.8 billion. The two companies will create a worldwide cancer diagnostics company, joining its two brands Cologuard and Oncotype DX, respectively. The combined company expects to generate revenue of approximately $1.6 billion and gross profit of approximately $1.2 billion in 2020.

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FDA clears iCubate iC-GN Assay

July 18, 2019—The U.S. Food and Drug Administration has cleared iCubate’s iC-GN Assay for the detection and identification of Gram-negative bacteria that are associated with bloodstream infection and subsequent sepsis.  

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Simplexa VZV Direct gets FDA clearance

June 13, 2019–DiaSorin Molecular received FDA clearance for its Simplexa VZV Direct assay for use with cerebrospinal fluid samples. The molecular diagnostic test enables the detection of varicella zoster virus DNA and aids in the diagnosis of meningitis and encephalitis.

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T2Bacteria pivotal trial publication

June 6, 2019—T2 Biosystems (Lexington, Mass.) announced that a study demonstrating the advantages of its T2Bacteria Panel and how it can aid in diagnosing blood stream infections was published in the Annals of Internal Medicine (Nguyen MH, et al. Epub ahead of print May 14, 2019). The panel identifies five ESKAPE bacteria--Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, andEscherichia coli—in three to five hours.

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FDA OKs diagnostic tests for extragenital testing for CT/NG

June 5, 2019—Two diagnostic tests for extragenital testing for chlamydia and gonorrhea have received 510(k) clearance by the U.S. Food and Drug Administration. The Aptima Combo 2 Assay (Hologic) and the Xpert CT/NG (Cepheid) are the first devices cleared for detecting the presence of Chlamydia trachomatisand Neisseria gonorrhoeaevia the throat and rectum. These tests were previously only cleared for testing urine, vaginal, and endocervical samples.  

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FDA approves Qiagen PIK3CA CDx

June 3, 2019—Qiagen announced the launch of its Therascreen PIK3CA RGQ PCR Kit after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with Piqray (alpelisib, Novartis), which was co-approved by the FDA.

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TV/MG test added to Cobas 6800/8800 menu

May 31, 2019—The Food and Drug Administration cleared the Cobas TV/MG test for use on the Cobas 6800/8800 systems for the detection of Trichomonas vaginalis and/or Mycoplasma genitalium DNA in symptomatic and asymptomatic patients. Laboratories can now simultaneously process from a single sample a combination of Chlamydia trachomatisNeisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.

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Alverno goes digital with Philips IntelliSite

May 23, 2019—Royal Philips and Alverno Laboratories announced that Alverno will fully implement digital pathology in its clinical laboratories. The laboratory network will use Philips IntelliSite Pathology Solution to assess and diagnose all clinical histology cases digitally.

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DxA 5000 total lab automation solution CE marked

May 9, 2019—Beckman Coulter announced that its DxA 5000 total laboratory automation solution has achieved the CE mark and China Food and Drug Administration approval. The DxA 5000 aims to deliver rapid and consistent turnaround time, provide a new level of comprehensive preanalytical sample quality detection, and reduce the number of manual processing steps.

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BD Bactec platelet QC media FDA-cleared, CE-IVD marked

April 29, 2019—BD announced the worldwide availability of BD Bactec platelet quality control media to identify contaminated platelet units. The product can be used for quality control testing of leukocyte reduced apheresis platelet units—leukocyte reduced single and a pool of up to six units of leukocyte reduced whole blood platelet concentrates.

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Beckman Coulter’s Early Sepsis Indicator gets 510(k) clearance

April 22, 2019—Beckman Coulter announced that its Early Sepsis Indicator has received 510(k) clearance from the U.S. Food and Drug Administration. The Early Sepsis Indicator is a hematology-based cellular biomarker designed to help emergency department physicians identify patients with sepsis or who are at an increased risk of developing sepsis and is reported automatically as part of a routine CBC with differential test.

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FDA approves Therascreen FGFR kit + erdafitinib

April 17, 2019—Qiagen announced the U.S. launch of its Therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic to help guide the use of the FGFR kinase inhibitor Balversa (erdafitinib; Janssen Biotech). The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 gene. The FDA co-approved the test with Balversa.

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OncoLens offers free virtual tumor board platform

In response to the ongoing challenges for cancer care teams due to the COVID-19 pandemic, OncoLens is offering its OncoLens virtual tumor board software at no cost for 60 days after signing a business associate agreement, through May 15, 2020. The module enables cancer care teams to meet virtually, in real time, to discuss treatment options for their cancer patients on a secure, HIPAA-compliant platform.

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FDA approves Tecentriq + chemo for ES-SCLC

March 25, 2019—Genentech announced FDA approval of Tecentriq (atezolizumab) in combination with carboplatin and etoposide for the initial treatment of adults with extensive-stage small cell lung cancer. “Extensive-stage small cell lung cancer is a highly aggressive form of lung cancer, which until now has seen limited treatment advances over the last 20 years,” Andrea Ferris, president and CEO of Lungevity ...

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FDA clears digital PCR test for monitoring CML therapy

Feb. 19, 2019—Bio-Rad Laboratories announced that its QXDx AutoDG ddPCR System, which uses the company’s droplet digital PCR technology, and the QXDx BCR-ABL %IS Kit received FDA clearance. The system and kit, when used together, can monitor molecular response to treatment in patients with chronic myeloid leukemia. “Bio-Rad is proud to announce our first FDA-cleared liquid biopsy test in oncology,” ...

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Health Network Labs buys Connective Tissue Gene Tests

Jan. 15, 2019—Health Network Laboratories has acquired Connective Tissue Gene Tests LLC (Allentown, Pa.), a provider of molecular diagnostic testing services for inherited genetic disorders. CTGT uses its proprietary analytic methods, mutation database, and technology to provide more than 3,300 unique tests covering more than 1,000 genes. “The acquisition of CTGT will complement HNL’s comprehensive clinical genetic laboratory service programs ...

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Luminex acquires MilliporeSigma’s flow cytometry portfolio

Jan. 14, 2019—Luminex has completed its acquisition of MilliporeSigma’s flow cytometry portfolio for $75 million. The flow cytometry portfolio includes the Amnis family of imaging flow cytometry products for cell-based analysis and the Guava portfolio of microcapillary flow cytometry systems. “The Amnis and Guava products complement our wide range of existing flow-based offerings, further differentiating our portfolio and ensuring we ...

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BD Max enteric panel gets FDA clearance

Jan. 11, 2019—BD announced FDA 510(k) clearance of its BD Max enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis. The panel is designed for targeted detection of the viral cause of infectious diarrhea symptoms and can detect norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus. “We continue ...

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FDA clears two ePlex blood culture identification panels

Dec. 28, 2018—GenMark Diagnostics has received FDA 510(k) market clearance for its ePlex Blood Culture Identification Fungal Pathogen Panel. This panel, together with the ePlex Blood Culture Identification Gram-Positive Panel, which received FDA clearance Dec. 20, and Gram-Negative Panel were developed for the diagnosis and disease management of bloodstream infections that can lead to sepsis.

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Beckman Coulter releases cloud-based middleware solution

Dec. 21, 2018—Beckman Coulter announced the U.S. release of its DxOne Workflow Manager, cloud-based middleware that aims to help low-volume laboratories standardize workflows, automate processes, and consolidate information. Technologists can manage samples by exception using autoverification and can get an at-a-glance view of ordering information and patient demographics on one screen. Comments and flags are readily visible, alerting users to ...

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Hycor gets clearance for Noveos allergy testing instrument

Dec. 20, 2018—Hycor Biomedical received FDA 510(k) clearance for its new allergy testing system, Noveos. Features of the system include a reduction in sample size (4 μL of serum per test), reduced blood-based interferences, less variability within allergen lots, increased accuracy, and improved walkaway time, the company reports. “Hycor has a long history of being at the forefront of allergy ...

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Twelve assays get PMA for Siemens’ Atellica

Dec. 18, 2018—Siemens Healthineers has been granted 12 premarket approvals from the FDA for its infectious disease and oncology testing menu. “These 12 PMA assays, combined with recently released High-Sensitivity Troponin I and Procalcitonin assays, provide a comprehensive menu on the Atellica Solution. Laboratories seeking a broad menu supporting the needs of their clinicians and patients can now find it ...

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Sonic buys Aurora Diagnostics

Dec. 14, 2018—Australian pathology and radiology group Sonic Healthcare will buy  Florida-based Aurora Diagnostics for $540 million. “The transaction will transform Sonic’s U.S. business, providing it with a strategic national footprint and platform that adds significant scale and extends Sonic’s existing presence in anatomic pathology,” Sonic said in a statement.

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Quest to buy lab services business of Boyce and Bynum

Dec. 13, 2018—Quest Diagnostics has signed a definitive agreement to acquire the assets of the clinical laboratory services business of Boyce and Bynum Pathology Laboratories; BBPL’s anatomic pathology division, long-term care division, and Boyce and Bynum Pathology Professional Services are not part of the transaction. Through a separate professional services agreement, BBPPS will become the exclusive pathology provider for Quest ...

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Qiagen launches panel, software for blood cancers

Dec. 7, 2018—Qiagen launched two novel products to deliver actionable insights on a wide range of blood cancers: a workflow for the Qiagen Clinical Insight Interpret bioinformatics solution for hematological malignancies, and the QIAact Myeloid DNA UMI Panel for use in myeloid neoplasm research using the company’s GeneReader NGS System. The QIAact myeloid panel provides an integrated sample-to-insight workflow targeting ...

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Beckman Coulter rolls out DxOne Inventory Manager

Dec. 3, 2018—Beckman Coulter announced the commercial availability of the DxOne Inventory Manager, its automated, cloud-based software technology that aims to simplify inventory management and enhance operational efficiencies to help ensure timely delivery of patient test results. “For many laboratories, managing supplies involves repetitive, time-consuming, and often manual tasks. DxOne Inventory Manager eliminates the administrative aspects of supply management by ...

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Vitros HIV Combo test gets expanded approval

Nov. 30, 2018–Ortho Clinical Diagnostics announced that its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator received FDA approval for use on the company’s Vitros ECi/ECiQ Immunodiagnostic Systems. Vitros HIV Combo, a fourth-generation test, detects HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag). “Early detection of HIV-1 is critical in getting patients into treatment as soon as ...

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Roche launches IVD pan-TRK IHC assay

Nov. 29, 2018—Roche announced the worldwide launch of the Ventana pan-TRK (EPR17341) Assay, an automated in vitro diagnostic immunohistochemistry assay to detect tropomyosin receptor kinase proteins in cancer. The CE IVD/U.S. class I assay is designed to detect C-terminal protein expression, which allows for the detection of TRK-fusion as well as wild-type protein expression. “As the first test of its kind, ...

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FDA clears Simplexa group B strep assay

Nov. 27, 2018—DiaSorin Molecular announced that the FDA has cleared its Simplexa GBS Direct assay for diagnostic use. Designed for use on the Liaison MDX instrument, the highly sensitive assay enables qualitative detection of group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Assay results can be used as an ...

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Luminex offers white paper on preventing CDI

A white paper titled “Can Global Testing for C. difficile Carriers Help to Prevent Healthcare-associated CDI?” from Luminex discusses the results of two recent studies that show that performing C. difficile testing only in patients with clinically significant diarrhea may be missing an opportunity to prevent CDI transmission from asymptomatic carriers. Download the white paper.

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FDA OKs Vitros HIV Combo on Vitros 5600

Nov. 15, 2018—Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator received FDA approval for use on Ortho’s Vitros 5600 Integrated System. The Vitros HIV Combo, a fourth-generation test, detects both HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag). “Ortho is committed to expanding its assay menu to meet current guidelines and testing needs,” Jennifer ...

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Siemens ELF test designated as a breakthrough device

Nov. 14, 2018—The FDA has granted a breakthrough device designation for the Advia Centaur Enhanced Liver Fibrosis Test from Siemens Healthineers. The ELF Test would support clinicians, in conjunction with additional clinical evidence, in assessing the fibrosis stage of chronic liver disease through a blood test. The test is designed to analyze data regarding three serum biomarkers—hyaluronic acid, procollagen III ...

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Hologic adds Open Access functionality to Panther Fusion

Nov. 13, 2018—Hologic announced the availability of Open Access functionality for its Panther Fusion system. The enhanced functionality will allow CLIA-certified laboratories to develop laboratory-developed tests to run on the fully automated Fusion platform. Laboratories will be able to run their LDTs simultaneously with commercially available IVD assays, and results will release automatically to laboratory information systems. “We know that ...

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NeuMoDx launches molecular systems at AMP

Nov. 12, 2018—NeuMoDx Molecular announced the U.S. launch of its FDA 510(k)-cleared NeuMoDx 288 Molecular System and its FDA-listed NeuMoDx 96 Molecular System at the Association for Molecular Pathology annual meeting in San Antonio. The fully automated systems integrate the molecular diagnostic process, from extraction to detection, with the first result available in approximately one hour. The analyzers offer operators ...

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MediPath selects NovoPath as its AP LIS

Nov. 8, 2018—NovoPath announced that its anatomic pathology software platform has been selected by MediPath as its laboratory information system. “During the thorough selection process, MediPath had an opportunity to survey the capabilities of several vendors,” Sandra Aponte, MD, medical director and lead pathologist for MediPath, said in a statement. “NovoPath’s solution best aligned with MediPath’s needs and offered the ...

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Illumina to buy PacBio for $1.2 billion

Nov. 7, 2018—Illumina announced it will acquire Pacific Biosciences for approximately $1.2 billion. With this acquisition, Illumina will be positioned to provide integrated workflows and novel innovations that bring together both Illumina’s short-read sequencing platforms with PacBio’s long-read sequencing capabilities to help researchers advance their discoveries faster and clinicians offer new tests economically. “PacBio’s unmatched accuracy mirrors that of Illumina’s ...

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FDA clears Ortho’s Vitros XT 7600 Integrated System

Nov. 5, 2018—Ortho Clinical Diagnostics received FDA clearance for its Vitros XT 7600 Integrated System. The Vitros XT 7600 uses the company’s Digital Chemistry technology, which combines microslide technology, digital imaging, and dry slide technology. “It’s an exciting time for clinical labs, and today’s clearance of Ortho’s Vitros XT 7600 System represents a fundamental improvement in the way labs can ...

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Illumina launches TruSight Oncology 500

Nov. 1, 2018—Illumina  launched its TruSight Oncology 500, a comprehensive next-generation sequencing assay. TSO 500 uses DNA and RNA to identify multiple variant types, including small nucleotide variants, indels, splice variants, fusions, and tumor mutational burden and microsatellite instability from the same formalin-fixed, paraffin-embedded tumor sample. The panel contains 1.94 Mb of genomic content to measure TMB and offers sophisticated variant ...

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Abbott next-gen influenza A & B, strep A assays

Oct. 29, 2018—Abbott announced FDA clearance and CLIA waiver of its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. The Influenza A & B 2 assay detects and differentiates influenza A and B virus in 13 minutes or less, with early call out of positive results in as few as five minutes. The ...

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NeoGenomics to acquire Genoptix

Oct. 26, 2018—NeoGenomics has entered into a definitive agreement to acquire Genoptix for $125 million in cash and 1 million shares of NeoGenomics common stock. “The acquisition of Genoptix enhances NeoGenomics’ leadership in the oncology test market, significantly expanding our coverage of oncology practices, increasing our customer reach, and leaving us better positioned for growth,” Douglas M. VanOort, NeoGenomics’ chairman ...

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Xifin rolls out RPM 10

Oct. 24, 2018—Xifin unveiled its Xifin Revenue Performance Management 10 to help diagnostic providers improve revenue, performance, and client and patient engagement. Xifin RPM 10 is a machine learning-enabled diagnostic revenue cycle management system that delivers an FASB-, GAAP-, and SOX-compliant and GL-ready financial package. Its new business intelligence capabilities include subject-oriented and aggregated data, data visualization, and analytics to ...

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BRACAnalysis CDx approved as Talzena companion dx

Oct. 22, 2018—Myriad Genetics announced that the FDA has approved its BRACAnalysis CDx to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are eligible for treatment with Pfizer’s PARP inhibitor, Talzena (talazoparib). Talzena is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast ...

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Therascreen EGFR RGQ PCR kit approved as CDx

Oct. 1, 2018—Qiagen announced that the FDA has approved a PMA supplement expanding the labeling claim of the Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or an exon 21 L858R mutation.

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Roche announces availability of FoundationOne Liquid

Sept. 27, 2018—Roche announced that its FoundationOne Liquid, a blood-based genomic profiling test, is available worldwide. FoundationOne Liquid can identify circulating tumor DNA in the blood of people with cancer and can identify 70 of the most commonly mutated genes in solid tumors, including microsatellite instability.

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Beckman releases new version of middleware

Sept. 12, 2018–Beckman Coulter launched version 1.10 of its Remisol Advance middleware system for mid- to high-volume laboratories. Enhancements include a centralized dashboard that combines sample status information (pending, stat, validated, and processed), turnaround time data, and quality control alerts in an intuitive format. “By providing a snapshot display of important analytics in a single location, we are enabling technologists ...

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Fingerstick Sofia 2 Lyme FIA gets FDA clearance, CLIA waiver

Sept. 6, 2018—Quidel has received 510(k) clearance and Clinical Laboratory Improvement Amendments waiver from the FDA to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from fingerstick whole blood specimens from patients suspected of B. burgdorferi infection. The test is ...

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Study: SelectMDx cost-effective in four European countries

Aug. 30, 2018—MDxHealth announced that a study validating the cost-effectiveness of SelectMDx for Prostate Cancer has been published in Prostate Cancer and Prostatic Diseases (Govers TM, et al. Epub ahead of print Aug. 20, 2018. doi:10.1038/s41391-018-0076-3). The study evaluates the potential cost-effectiveness of SelectMDx, a noninvasive liquid biopsy test to identify patients at increased risk of aggressive prostate cancer, in a ...

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Techlab gets FDA clearance for H. pylori tests

Aug. 22, 2018—Techlab received FDA 510(k) clearance for its H. Pylori Quik Chek and H. Pylori Chek tests. The tests aim to offer quick and reliable detection of Helicobacter pylori–specific antigen in human fecal specimens. The H. Pylori Quik Chek test is a rapid diagnostic test that detects H. pylori in 30 minutes. The H. Pylori Chek test is a 96-well plate ...

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Study: DCISionRT predicts radiation therapy benefit

Aug. 9, 2018—Prelude Corp. announced that Clinical Cancer Research published results from a large cross-validation study of DCISionRT in patients with ductal carcinoma in situ (Bremer T, et al. Epub ahead of print July 27, 2018. doi:10.1158/1078-0432.CCR-18-0842). The multisite study demonstrated that DCISionRT was a strong predictor of radiation benefit and was able to identify patients with significantly elevated recurrence ...

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Beckman releases DxM MicroScan

Aug. 7, 2018—Beckman Coulter announced commercialization of its DxM MicroScan WalkAway system, a diagnostic solution for bacterial identification and antibiotic susceptibility testing that uses direct minimum inhibitory concentrations for detection of antimicrobial resistance. The system’s delivery of gold-standard MIC accuracy helps laboratories achieve their operational goals by reducing costs associated with confirmatory testing, the company says. Added workflow enhancements include ...

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Sysmex, Advanced Instruments offer CSF cell counter

Aug. 6, 2018—Sysmex America and Advanced Instruments announced a partnership that will broaden the Sysmex portfolio with Advanced Instruments’ automated GloCyte cell counter system. The GloCyte system uses a combination of fluorescence, microscopy with digital image analysis, highly specific reagents, and an intelligent counting algorithm to provide accurate counts down to zero for both red blood cell and total nucleated ...

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FDA approves Cobas HPV Test with SurePath

Aug. 3, 2018—Roche has received FDA approval for the Cobas HPV Test to be used as the first-line screening test for cervical cancer in women 25 and older using specimens collected in SurePath preservative fluid. The Roche test is now the only HPV test approved for use as a primary screening test with both SurePath and ThinPrep PreservCyt Solution. It ...

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MedTest chem assays, hematology analyzer

Aug. 2, 2018—MedTest Dx introduced its BA-800M Clinical Analyzer for general chemistry with a full line of reagents and launched its BC-5390 5-Part Differential Hematology Analyzer at the 2018 American Association for Clinical Chemistry Annual Scientific Meeting, in Chicago. The MedTest Dx BA-800M is a fully automated, discrete random-access chemistry analyzer designed for mid- to large-volume clinical testing laboratories now ...

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Beckman Coulter, Arkray launch iQ Workcell

Aug. 1, 2018—Beckman Coulter and U.S. Arkray announced a partnership and the launch of the iQ Urinalysis Workcell, which pairs Beckman’s Iris iQ200 Digital Flow Morphology system with the Arkray Aution Max AX-4030 fully automated urine analyzer. The iQ Urinalysis Workcell will be available in the U.S. exclusively through Beckman Coulter; the company will also offer the Aution Max AX-4030 ...

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FDA clears Siemens’ TnIH assays

July 30, 2018—Siemens Healthineers announced FDA clearance of its High-Sensitivity Troponin I assays (TnIH) for its Atellica IM and Advia Centaur XP/XPT in vitro diagnostic analyzers to aid in the early diagnosis of myocardial infarctions. The high sensitivity of the TnIH assays “offers the ability to detect lower levels of troponin at significantly improved precision at the 99th percentile and ...

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Qiagen broadens GeneReader applications

July 27, 2018—Qiagen has introduced next-generation sequencing solutions for a range of hereditary diseases on its GeneReader NGS System. The customizable QIAact target enrichment panels enable the analysis of more than 13 hereditary disease groups, including inherited cancers, cystic fibrosis, inherited cardiovascular diseases, and universal carrier screening. The solutions integrate the company’s QCI analysis, which includes the Human Gene Mutation ...

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Leica rolls out next-gen research stainer

July 26, 2018—Leica Biosystems introduced the Bond Rx next-generation research stainer. The new system offers greater flexibility when optimizing conditions for a variety of test types including immunofluorescence, immunohistochemistry, fluorescence in situ hybridization, tyramide signal amplification, multiplexing, and other emerging tests. Bond Rx allows users to customize dewax options, choose from six probe application and removal protocols, and select the ...

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Elecsys CSF assays get breakthrough approval

July 25, 2018—The Food and Drug Administration granted breakthrough device designation to Roche’s Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the ß-amyloid (1-42) and phospho-tau concentrations in cerebrospinal fluid in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of dementia. Measuring ...

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Qiagen offers AdnaTest for lung, prostate cancers

April 20, 2018—Qiagen launched two liquid biopsy panels to evaluate circulating tumor cells in prostate and lung cancers. The AdnaTest ProstateCancerPanel AR-V7 Kit and AdnaTest LungCancer Kit were introduced at the American Association for Cancer Research annual meeting, April 14–18, in Chicago. The AdnaTest ProstateCancerPanel AR-V7 Kit detects the androgen receptor splice variant 7 in CTCs of prostate tumor origin ...

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Meridian launches TruBlock Ready

April 19, 2018—Meridian Life Science launched TruBlock Ready, a broad-acting HAMA blocker that is ready to use within a single dilution step. TruBlock Ready employs an active blocking technology that results in higher blocking efficiency than conventional blockers and provides broad coverage against human anti-mouse antibody, rheumatoid factor, and heterophilic antibodies. The blocking effectiveness has been proven in ELISA and ...

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Sakura launches Tissue-Tek Prisma Plus

April 13, 2018—Sakura Finetek USA launched its Tissue-Tek Prisma Plus Automated Slide Stainer, a second-generation Prisma platform with a throughput of 530 slides per hour. “Like its predecessor, the Tissue-Tek Prisma Automated Slide Stainer, with several thousand units installed worldwide, Tissue-Tek Prisma Plus continues to be the slide stainer of choice for large commercial laboratories and hospitals,” George R. Kennedy, ...

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Beckman introduces Access Sensitive Estradiol

April 11, 2018—Beckman Coulter Diagnostics announced the launch of its Access Sensitive Estradiol assay in the U.S. and in a majority of markets worldwide. The test is commonly ordered for detecting estradiol levels in women, children, and men. The assay aims to help laboratories deliver more accurate results for patients seeking answers to reproductive health questions. It has a broad ...

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DiaSorin gets FDA clearance for PCT assay

April 6, 2018—DiaSorin received clearance from the Food and Drug Administration to market the Liaison Brahms PCT II Gen assay for the quantitative determination of procalcitonin. “I am pleased to announce the addition of the Brahms PCT II Gen assay to our growing specialty menu in the U.S. market”, John Walter, president of DiaSorin, said in a statement. “I’m proud ...

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FDA authorizes DexcomG6 CGM system

March 30, 2018—The FDA has granted a de novo request to Dexcom for its Dexcom G6 integrated continuous glucose monitoring system for determining blood glucose levels for people with diabetes ages two and up. This is the first type of CGM system permitted by the agency to be used as part of an integrated system with other compatible medical devices ...

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Roche launches digital pathology slide scanner

March 28, 2018—Roche launched the Ventana DP 200 high-speed slide scanner for digital pathology. The scanner features a tray-based design that enables no-touch slide processing for reduced workflow and a scan speed of less than 49 seconds for a 15-by-15 millimeter scan area. It is Digital Imaging and Communications in Medicine (DICOM) standard compatible and integrates with image management servers, ...

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CAP TODAY webinar on BRCA mutation testing

March 26, 2018—CAP TODAY is hosting a webinar titled “Developing Perspectives on BRCA Testing: New Horizons for Breast Cancer” on Thursday, March 29, 1:30 PM ET. Tabetha Sundin, PhD, HCLD(ABB), MB(ASCP)CM, and Leigha Senter-Jamieson, MS, LGC, will discuss the rationale for BRCA mutation testing in breast cancer, the key highlights of the BRCA testing and interpretation process, and reconsidering multidisciplinary ...

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Webinar: NGS in NSCLC biomarker testing

March 23, 2018—CAP TODAY is hosting a webinar titled “Endeavor to leave no patient behind: next-generation sequencing (NGS) in routine NSCLC biomarker testing” on Wednesday, March 28, 1 PM ET. Boaz Kurtis, MD, medical director of Cancer Genetics, Inc., will discuss how to practice precision oncology based on fast-changing guidelines and to ensure even challenging samples get tested to achieve best ...

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FDA clears first DTC genetic test on cancer risk

March 16, 2018—23andMe received the first FDA authorization for a direct-to-consumer genetic test for cancer risk. The authorization allows 23andMe to provide customers, without a prescription, information on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population. ...

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FDA clears POC Sofia Lyme FIA for Sofia 2

March 15, 2018—Quidel received 510(k) clearance from the FDA to market its Sofia Lyme FIA to be used with the Sofia 2 fluorescent immunoassay analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection, which causes Lyme disease. “The Sofia Lyme Assay’s 510(k) ...

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Randox teams up with Bosch

March 14, 2018—Randox Laboratories and Bosch Healthcare Solutions will unveil Vivalytic, a fully automated molecular diagnostics platform, at the 28th European Congress of Clinical Microbiology and Infectious Diseases, April 21–24, in Madrid. Vivalytic supports end-point PCR, quantitative real-time PCR, melting curve analysis, and microarray technology, enabling singleplex, low-plex, and high multiplex testing on the same device. Depending on the test ...

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FDA OKs Imfinzi for unresectable stage III NSCLC

March 13, 2018—AstraZeneca and MedImmune, its biologics research and development arm, announced the FDA has approved Imfinzi (durvalumab) for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. “This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the ...

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Diaceutics teams up with Lenovo and Intel

March 9, 2018—Diaceutics, based in Dundalk, Ireland, will collaborate with tech companies Lenovo and Intel to leverage their vast proprietary database of patient testing data. Diaceutics will use artificial intelligence to see whether patients can be grouped according to diagnostic test information in hopes the data can help identify ways to improve diagnosis, treatment, and outcomes for patients with similar ...

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BD HPV assay gets premarket approval

March 8, 2018—Becton Dickinson received premarket approval from the FDA for the BD Onclarity HPV assay. The test detects 14 types of high-risk human papillomavirus from specimens collected for cervical cancer screening in the BD SurePath liquid based cytology vial. The assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers and ...

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CAP TODAY webinar on molecular testing in AML

March 6, 2018—CAP TODAY is hosting a webinar titled “Molecular Testing in AML: From Today to Tomorrow” on Wednesday, March 7, 1 PM ET. This hourlong webinar is presented by Pritish K. Bhattacharyya, MD, and moderated by CAP TODAY publisher Bob McGonnagle. The webinar will allow you to understand the complexities of acute myeloid leukemia, learn the common mutations tested ...

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Helmer Scientific launches next-gen cell washer

March 2, 2018—Helmer Scientific has announced the release of its FDA 510(k)-cleared, next-generation automatic cell washing system, the UltraCW II, for hospital blood banks and clinical laboratories. The UltraCW II automates steps within typical tube testing blood bank workflows. It removes plasma and unwanted antibodies from blood cells for pretransfusion testing procedures—ABO and Rh grouping, antibody identification, and cross-matching. The ...

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CDC to use IGRAs for immigration TB screening

Feb. 28, 2018—The U.S. Centers for Disease Control and Prevention issued a notification to U.S. civil surgeons stating it will require the use of FDA-approved interferon gamma release assays for tuberculosis screening. The CDC plans for the change to go into effect Oct. 1. The use of the tuberculin skin test will no longer be allowed for use in immigration screening, ...

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Respiratory bacterial panel gets CE-IVD mark

Feb. 28, 2018—ElitechGroup Molecular Diagnostics launched its Respiratory Bacterial Elite MGB Panel, a high-performance multiplex assay for the diagnosis of bacterial respiratory infections and validated with the Elite InGenius fully automated sample-to-result system. The panel detects and differentiates in a single reaction M. pneumoniae, C. pneumoniae, and L. pneumophila. A clinical study has demonstrated a performance of 100 percent diagnostic sensitivity ...

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FDA clears QuickVue Influenza A+B test

Feb. 27, 2018—Quidel announced it has received FDA 510(k) clearance for its CLIA-waived QuickVue Influenza A+B assay. The assay allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients in approximately 10 minutes. In a clinical study, the QuickVue Influenza A+B test was shown to ...

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FDA clears Sebia Hydrashift 2/4 daratumumab assay

Feb. 26, 2018—Sebia announced it has received FDA 510(k) clearance for its Hydrashift 2/4 daratumumab assay, intended to be used with Hydragel IF, for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. This in vitro diagnostic reagent mitigates the daratumumab-mediated interference seen in immunofixation results for patients with multiple myeloma treated with Darzalex (daratumumab), a fully ...

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CAP TODAY webinar on influenza testing

Feb. 22, 2018—CAP TODAY is hosting a webinar titled “Diagnostic Accuracy of Novel and Traditional Rapid Tests for Influenza Compared with Reverse Transcriptase PCR” on Tuesday, Feb. 27, 1 PM ET. Presented by Jesse Papenburg, MD, MSc, FRCPC, and moderated by CAP TODAY publisher Bob McGonnagle, this hourlong webinar will empower you to understand new approaches to influenza testing and ...

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Qiagen to buy Stat-Dx

Feb. 20, 2018—Qiagen has entered into an agreement to acquire Stat-Dx, a developer of molecular diagnostics systems, for $147 million. Once the transaction is completed, which is expected later this year, Qiagen will launch the QIAstat-Dx system, a next-generation, fully integrated multiplex platform for syndromic disease testing. QIAstat-Dx enables scalable sample-to-insight processing of up to 48 molecular targets simultaneously and ...

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Qiagen launches Therascreen PITX2 test in Europe

Feb. 14, 2018—Qiagen announced the European launch of its novel Therascreen PITX2 RGQ PCR Kit, a clinically validated DNA methylation assay that helps predict the response of certain high-risk breast cancer patients to anthracycline-based chemotherapy. The CE-IVD marked assay is Qiagen’s first epigenetic test in breast cancer. “We are very pleased to introduce this important test for personalized health care ...

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Inspirata buys digital pathology company Omnyx

Feb. 13, 2018—Inspirata, a biotechnology and software company, announced it has acquired Pittsburgh-based Omnyx from GE Healthcare. Omnyx’s flagship digital pathology software, Dynamyx, aims to enhance the pathology workflow by providing new channels for collaboration and tools to boost efficiency. The software is CE-marked in Europe and licensed by Health Canada for in vitro diagnostic use. “The acquisition of Omnyx ...

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Alcor Scientific’s iSED at the Winter Olympics

Feb. 9, 2018—Alcor Scientific announced its iSED Analyzer will be used by the laboratory at the Korean Medicine Center at the Pyeongchang 2018 Olympic Winter Games and Paralympic Winter Games. The iSED is a fully automated erythrocyte sedimentation rate analyzer that analyzes red blood cells to diagnose bacterial infections and inflammation as well as to monitor patients’ responses to medications ...

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Advanced Instruments single-sample osmometer

Feb. 8, 2018—Advanced Instruments announced its Osmo1 Single-Sample Micro-Osmometer. It is suited for clinical laboratories that directly draw and test small sample volumes and was designed specifically to improve efficiency and reduce sample turnaround time. The instrument measures the osmolality of body fluids, such as whole blood, serum, plasma, urine, feces, sweat, and tissue homogenate, using the freezing point depression ...

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FDA: Rethink how diagnostics are regulated

Feb. 6, 2018—U.S. Food and Drug Administration commissioner Scott Gottlieb, MD, said we need to think differently about how we regulate diagnostics. “It’s been a little bit more challenging to define a pathway on how to get regulatory approval for the diagnostic at the same time you get regulatory approval for the drug, in part because a lot of these ...

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Houston Methodist cytopathology symposium

Jan. 15, 2018—The Department of Pathology and Genomic Medicine at Houston Methodist Hospital will be presenting a symposium, “Cytopathology and Small Biopsy: Update in the Texas Medical Center at Houston Methodist Hospital,” at the Houston Methodist Research Institute on Saturday, March 3. Through didactic lectures, panel discussions, and poster presentations, symposium attendees will learn how the new Bethesda System for ...

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Perjeta OK’d for neoadjuvant use

Jan. 3, 2018—Genentech announced Dec. 20 the FDA’s approval of Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. People should receive the adjuvant Perjeta-based regimen for one year (up to 18 cycles). The FDA has also converted the previously granted accelerated approval of ...

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