The past few months has shown that a team’s rapid response to expediting an assay globally, dedicated to the detection of SARS-CoV-2, is possible. BioGX, in a long-term partnership with Becton, Dickinson and Company, has submitted a test to the FDA for emergency use authorisation (EUA) in the US, in parallel to CE-IVD approval. In these challenging times, laboratories around the world have an urgent need for an easy-to-use, reliable test to detect SARS-CoV-2 to determine if patients have contracted COVID-19. Authorisation to use these tests worldwide would increase access to highly reliable results.
FRANKLIN LAKES, N.J. and BIRMINGHAM, Ala., April 3, 2020
BD (Becton, Dickinson and Company) a leading global medical technology company, and BioGX Inc., a molecular diagnostics company, today announced that the U.S. Food and Drug Administration (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. Read more
Becton Dickinson and BioGX announced Friday that they received Emergency Use Authorization from the US Food and Drug Administration for a hospital SARS-CoV-2 test. Read more