Review of COVID-19 tests remains top priority -acting U.S. FDA chief
January 11, 2022 at 10:40 am EST
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WASHINGTON, Jan 11 (Reuters) - The U.S. Food and Drug
Administration is focused on reviewing at-home and other
COVID-19 tests, particularly those that can be manufactured at
scale, Acting FDA Commissioner Janet Woodcock said at a Senate
hearing on Tuesday.
(Reporting by Susan Heavey)
OraSure Technologies, Inc. provides point-of-care and home diagnostic tests, sample management solutions, and microbiome laboratory and analytical services. The Company's product portfolio is divided into diagnostics products and sample management solutions. Its business consists of the development, manufacture, marketing and sale of diagnostic products and specimen collection devices using its technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Its diagnostic products include tests for diseases including COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs of abuse that are processed in a laboratory. Its business also includes molecular sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers.