FDA grants emergency use authorization for new COVID-19 diagnostic for use in U.S- BD + BioGX Inc.
-BD (Becton, Dickinson and Company) , a leading global medical technology company, and BioGX Inc., a molecular diagnostics company, announced that the FDA has granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen for COVID-19 (coronavirus) on site and get results in under three hours.
The test helps fill an urgent need across the U.S. for hospitals to access an easy-to-use, rapid diagnostic test to screen patients and health care workers for COVID-19. The test will be run on the BD MAX System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. Each unit is capable of analyzing hundreds of samples per day.