In April 2020, the company’s COVID-19 antibody test was one of the first to be granted Emergency Use Authorization (“EUA”) by the U.S. Food and Drug Administration (“FDA”). Then, before the market opened on June 17, 2020, the EUA for Chembio’s Dual Path Platform COVID-19 serology test was revoked by the FDA due to concerns regarding the test’s accuracy. Specifically, the FDA found that the “benefits no longer outweigh its risks” and that “it is not reasonable to believe that the test may be effective” because it “generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device.” The company’s share price fell $6.04 on this news, or nearly 60%, to close at $3.89 per share on June 17, 2020.
Chembio Diagnostic System, Inc.
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