NEW YORK – Becton Dickinson and BioGX said on Monday that they have submitted a test to detect SARS-CoV-2, the virus that causes COVID-19, that runs on the BD Max system to the US Food and Drug Administration for Emergency Use Authorization. If authorized, the test could potentially increase screening capacity in the US.
The assay is part of a long-standing collaboration around developing BioGX assays for the BD Max system. The new COVID-19 test will also run on the BD Max, a fully automated system that can process 24 samples simultaneously.
In a statement, BD noted that the BD Max is already in use in hundreds of labs and in nearly every state.
"The collaboration with BioGX to deliver a COVID-19 diagnostic in the US is another example of BD's commitment to help with the global COVID-19 pandemic and combat the spread of infectious diseases," said Nikos Pavlidis, BD's VP and general manager, molecular diagnostics and women's health, in a statement.
Shazi Iqbal, CEO of BioGX, noted that "these are challenging times for all of us, more so for our laboratory partners who have an urgent need for an easy-to-use, reliable test to detect the SARS-CoV-2 to determine if patients have contracted COVID-19. ... Authorization to use our test would increase access across the US to an automated, highly reliable SARS-CoV-2 test."
Birmingham, Alabama-based BioGX received the CE mark for an influenza and respiratory syncytial virus test on the BD Max in 2016, followed in 2017 by CE marking for four other infectious disease assays — for mycoplasma and ureaplasma species, Pneumocystis jirovecii, Mycobacterium tuberculosis, and a Bordetella speciation and toxin test. In 2018, BioGX obtained the CE mark for six assays to detect meningitis and antibacterial resistance. Upon the CE marking of its expanded flu/RSV test in 2019, the firm noted that it had 23 tests CE marked on the BD Max system in total.