Tag: Antibody Test

FDA, Regulations

FDA clears a ‘new generation’ of Covid antibody test designed to tell how well someone is protected against the virus

November 25, 2020


The FDA on Wednesday authorized one of the first Covid-19 tests that measures the amount of neutralizing antibodies produced by the body’s immune system after exposure to the virus — a “new generation” of coronavirus test that is designed to […]

FDA, Regulations

COVID-19 Update: FDA Shares Antibody Test Performance Data

June 5, 2020

Via: Contract Pharma

The U.S. FDA posted test performance data from four more antibody, or serology, test kits on from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI). These results are among the […]


Genalyte Launches High-Speed COVID-19 Antibody Test

April 28, 2020

Via: Contract Pharma

Genalyte Inc. has made available its rapid COVID-19 serology panel on its Maverick platform. The panel tests for the detection of IgG and IgM antibodies that the body produces in response to the novel coronavirus (SARS-CoV-2). Genalyte’s U.S. Food and […]