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Keep up-to-date with the latest trends in management and clinical operation, regulatory changes, and finance.

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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Thermo Fisher’s blood test for Ara h 6 approved

Jan. 28, 2019—Thermo Fisher’s ImmunoCAP Specific IgE blood test for Ara h 6, part of a line of assays for detecting specific peanut allergen components, has been cleared by the FDA for in vitro diagnostic use. The test is designed to help allergists and other medical providers better predict which patients may be at risk for life-threatening sensitization to Ara ...

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FDA clears DiaSorin Bordetella test

Jan. 16, 2019—DiaSorin Molecular has received FDA clearance for its new Simplexa Bordetella Direct test. This CLIA moderate-complexity assay is designed for use on the Liaison MDX to provide qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis. The assay is performed directly from nasopharyngeal swab samples without extraction and provides results in about an hour. “We are very ...

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