FDA

FDA Issues EUA for GenScript’s Test Detecting Neutralizing Antibodies from COVID-19

By MedTech Intelligence Staff
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FDA

The serology test is the first of its kind to detect neutralizing antibodies from a recent or prior SARS-CoV-2 infection.

The first serology test that detects neutralizing antibodies from a COVID-19 infection has received an EUA from FDA. Provided by GenScript USA, Inc., the cPass SARS-CoV-2 Neutralization Antibody Detection Kit is intended to identify people who have an adaptive immune response to SARS-CoV-2, which can suggest a recent or previous infection.

“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in CDRH in an agency news release. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus. Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus.”

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