Chembio Sinks 59% In Pre-Market As FDA Revokes Its Covid-19 Test; Top Analyst Cuts Rating

Shares in Chembio Diagnostics (CEMI) sank 59% after the U.S. Food and Drug Administration revoked the Emergency Use Authorization (EUA) of its DPP (Dual Path Platform) COVID-19 serology test.The stock plunged to $4.10 in pre-market trading after the FDA said that there were performance concerns with the accuracy of Chembio’s SARS-CoV-2 antibody test. The U.S. regulator added that it made the decision to revoke the EUA authorization for the serology test as “benefits no longer outweigh its risks”.“This test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device,” …read more

Source:: Yahoo Finance

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