20/20 BioResponse to Launch Rapid Coronavirus Test Kits in U.S. following "Green Light" from FDA

ROCKVILLE, Md.--(BUSINESS WIRE)-- 20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc. announced today that it will begin taking orders for its CoronaCheck ™ COVID-19 Rapid Antibody Test Kit. (The test is intended to identify persons having an immune response against SARS-CoV-2.) The company’s action follows discussions with officials from the U.S. Food & Drug Administration (FDA) this week after the agency’s March 16 Guidance issued to “expand the number and variety of diagnostic tests” as the “severity and scope of the current COVID-19 situation around the globe necessitates greater testing capacity than is currently available.”

The test kits are rapid chromatographic immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to COVID-19 SARS-CoV-2 in blood, which is the cause of COVID-19. IgM antibody generally begins to rise within 1 week of initial infection. IgG appears about 14 days after infection. According to the March 16 FDA Guidance, antibody blood tests of this nature are “less complex” than the nucleic acid testing that the CDC and laboratories throughout the U.S. have been running since the start of this emergency.

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https://www.biospace.com/article/releases/20-20-bioresponse-to-launch-rapid-coronavirus-test-kits-in-u-s-following-green-light-from-fda/