The FDA has issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
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The new assays are designed for qualitative and quantitative measurements of multiple antibody types.
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Zeeshan Ahmed, PhD, of the Rutgers Institute for Health, Health Care Policy and Aging Research, discusses the future of precision medicine and the role genetics play during the covid-19 pandemic.
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The CFX Opus 96 and CFX Opus 384 Real-Time PCR Systems represent the next generation of Bio-Rad’s CFX Real-Time PCR Systems that are used in research and genomic testing as well as in pathogen detection and infectious disease testing.
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The agency has issued cease-and-desist letters to laboratories conducting covid-19 testing without appropriate certification.
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