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Author Archives: Kristen

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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