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Author Archives: Kristen

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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