Roche (RHHBY) announced that its first point-of-care test for the diagnosis of whooping cough, or pertussis, and other Bordetella infections, has been granted U.S. Food and Drug Administration 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 waiver, in addition to CE IVDR certification. “The groundbreaking PCR test uses the cobas liat system to deliver results in just 15 minutes in GP practices and Emergency Rooms. This speed enables physicians to diagnose patients during their consultation and take immediate action to provide appropriate antibiotics that can prevent severe complications and onward transmission,” the company stated.
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