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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 […]

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U.S. FAA chief to testify at hearing on jet certification after 737 MAX crashes

The head of the Federal Aviation Administration is set to testify on Wednesday before a Senate committee on the safety certification of jetliners like Boeing Co’s 737 MAX, still grounded after fatal crashes. The Senate Commerce committee hearing at 10 a.m. EDT (1400 GMT) gives lawmakers a chance to question FAA Administrator Steve Dickson about bipartisan legislation introduced Tuesday that would grant the FAA more power over Boeing’s aircraft designs. …read more […]