New scrutiny prompts withdrawal, re-evaluation of two rapid COVID-19 tests

A serological test withdrawal from BD and BioMedomics and reports of false negatives by Abbott’s point-of-care diagnostic highlight the need for regulatory oversight and independent validation in responses to the pandemic.

FDA’s May 4 update to its COVID-19 testing guidance led partners Becton Dickinson and Co. (NYSE:BDX) and BioMedomics Inc. to withdraw their rapid serological assay and develop a version of the test that meets the agency’s new standards...