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Chembio Diagnostics, Inc.

Company NameChembio Diagnostics, Inc.
Stock SymbolCEMI
Class PeriodApril 01, 2020 to June 16, 2020
Lead Plaintiff Motion DeadlineAugust 17, 2020

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, on June 17, 2020, before the market opened, the FDA revoked the EUA for Chembio’s Dual Path Platform COVID-19 serology test 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.” 

On this news, the Company’s share price fell $6.04, or nearly 60%, to close at $3.89 per share on June 17, 2020.

 

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