FDA yanks emergency use authorization of Chembio COVID-19 blood test

Citing concerns with accuracy, the FDA has revoked the emergency use authorization of Chembio’s (NASDAQ:CEMI) DPP COVID-19 IgM/IgG System, its SARS-CoV-2 antibody test.

Data submitted by the company and results from an independent evaluation of the test showed a higher-than-expected rate of false results that was higher than the device’s labeling.

The FDA OK’d the emergency use of the test on April 15.

https://seekingalpha.com/news/3583676-fda-yanks-emergency-use-authorization-of-chembio-covidminus-19-blood-test