Chembio Diagnostics (NSDQ:CEMI) announced that it received a $12.7 million contract from BARDA for its rapid COVID-19 test. Hauppauge, N.Y.-based Chembio said in a news release that the contract will support the development of and pursuit of FDA emergency use authorization (EUA) for its rapid, multi-plex DPP respiratory antigen panel point-of-care testing system ahead of […]
Chembio Diagnostics
FDA revokes EUA for COVID-19 antibody test
The FDA announced that it revoked the emergency use authorization (EUA) of the Chembio DPP COVID-19 antibody test due to accuracy concerns. Chembio’s IgM/IgG SARS-CoV-2 serological antibody test received EUA in March as a fingerstick-style test designed to use the company’s MicroReader 1 and MicroReader 2 analyzers to detect IgM and IgG antibodies and offer […]
Are coronavirus antibody tests all they’re cracked up to be?
With pressure mounting to get Americans back to work, the new focus is on tests that purport to indicate antibodies to the SARS-CoV-2. These serological tests are supposed measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19. Many companies in China have […]
Chembio, Molecule Holdings launch fingerstick COVID-19 tests
Chembio Diagnostics and Molecule Holdings announced the launch of their separate COVID-19 serological point-of-care tests for detecting antibodies associated with coronavirus. Chembio’s fingerstick-style test using its MicroReader 1 and MicroReader 2 analyzers is designed to detect IgM and IgG antibodies and offer results within 15 minutes, according to a news release. Chembio (Medford, N.Y.) said […]
