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![Two studies confirm a new variant in California is more contagious, but the scale of its threat is unclear.]()
Two studies confirm a new variant in California is more contagious, but the scale of its threat is unclear.
Written by Carl Zimmer RAD-x Rad Awardee Charles Chiu talks about the significance of the California variant. Read more
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![Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests Guidance for Test Developers and Food and Drug Administration Staff]()
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests Guidance for Test Developers and Food and Drug Administration Staff
Written by U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health (CDHR) Office of Product Evaluation and Quality (OPEQ) FDA is issuing this guidance to provide a policy and recommendations on evaluating the potential impact of emerging and future viral mutations of SARS-CoV-2 on COVID-19 tests for…
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![Editorial: U.S. FDA’s Experience with COVID-19 Antibody Tests]()
Editorial: U.S. FDA’s Experience with COVID-19 Antibody Tests
Precision Vaccinations: An editorial published by The New England Journal of Medicine (NEJM) highlights ‘establishing robust and coordinated national and international mechanisms for generating evidence and gathering, sharing, and disseminating information will be critical to ending the current pandemic and addressing future public health emergencies.’‘Moving forward, the US Food and Drug Administration (FDA) will continue to take…
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![VIC Foundry, Inc. Receives NIH RADx Funding for Development of an At-home Molecular Diagnostic Test for COVID-19]()
VIC Foundry, Inc. Receives NIH RADx Funding for Development of an At-home Molecular Diagnostic Test for COVID-19
Written by newsfeed VIC Foundry’s innovative designs for a low-cost at-home COVID-19 test Funding for the project is being provided by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program to support new approaches to nationwide COVID-19 testing and surveillance ALBUQUERQUE, N.M. (PRWEB) February 16, 2021 This diagnostic technology uses Sandia’s…
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![Luminostics Announces FDA Authorization and Production Scale-Up of US-Manufactured Smartphone-Based COVID-19 Rapid Test]()
Luminostics Announces FDA Authorization and Production Scale-Up of US-Manufactured Smartphone-Based COVID-19 Rapid Test
Written by newsfeed Components of the Clip COVID Test The reusable iPhone-based Clip Analyzer, the Clip COVID iOS app, and the single-use Cartridge, Swab, Extraction Tube, and Dropper Tip comprise the Clip COVID Rapid Antigen Test. Demo video of Clip COVID 3-minute video showing the simple end-to-end workflow of the Clip COVID Rapid Antigen Test.…
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![The FDA’s Experience with Covid-19 Antibody Tests]()
The FDA’s Experience with Covid-19 Antibody Tests
Written by newsfeed In January 2020, the Food and Drug Administration (FDA) began considering the U.S. response to Covid-19. On February 4, after the declaration of a public health emergency, we began authorizing tests to diagnose active infections. In such an emergency, the FDA can grant an emergency use authorization (EUA) for medical products on the…
