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Are you developing a test for COVID-19? Check out these important resources from the FDA.
- FDA’s Guidance for COVID-19 Diagnostic Tests during the Public Health Emergency.
- FDA FAQs on Diagnostic Testing for SARS-CoV-2 (typically updated daily)
- FDA List for Current Emergency Use Authorization (EUA)s for COVID-19
Also, tune into the FDA’s virtual Town Hall every Wednesday from 12:15 – 1:15 p.m. est. The agency answers technical questions about the development and validation of tests for SARS-CoV-2 and the recently issued guidance.
Looking for COVID-19 samples? Check out BEI Resources.
BEI Resources was established by the National Institute of Allergy and Infectious Diseases (NIAID) to provide reagents, tools and information for studying Category A, B, and C priority pathogens, emerging infectious disease agents, non-pathogenic microbes and other microbiological materials of relevance to the research community.
BEI Resources has coronavirus strains and reagents currently available and is prioritizing and fast tracking all SARS-CoV-2 orders.
Biodesix deployed its first COVID-19 ddPCR tests last week. The test reduces false negatives, requires only a nasal and throat swab, and provides results in 48 hours. Initial plans are to support the Colorado healthcare system with up to 1,000 tests daily. Biodesix deployed its first COVID-19 ddPCR tests last week. The test reduces false negatives, requires only a nasal and throat swab, and provides results in 48 hours. Initial plans are to support the Colorado healthcare system with up to 1,000 tests daily. If there are needs for testing for employers, factory workers, first responders, please send information to CovidTesting@Biodesix.com
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