Stock price of Chembio Diagnostics Inc (NASDAQ: CEMI) plummeted in pre-market hours after the Company announced that they received a letter from the U.S. Food and Drug Administration, or FDA, notifying them that the FDA was revoking the Emergency Use Authorization, or EUA, granted in April 2020 with respect to our DPP COVID-19 System, which consists of their serological test for COVID-19 and one of CEMI Micro Reader analyzers.
The DPP COVID-19 System was one of the first antibody tests authorized by the FDA during the COVID-19 public health emergency.
In its letter of June 16, 2020, the FDA stated that it had decided to revoke the EUA for the DPP COVID-19 System due to performance concerns regarding the sensitivity and specificity of our test system. According to the FDA, an independent evaluation of our test system by the National Institutes of Health’s National Cancer Institute, as well as other independent evaluations, showed
(a) test system generated a higher rate of false results than expected under our initial EUA request and our authorized labeling and
(b) it is not reasonable to believe that test system may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test system outweigh its known and potential risks.