October 28, 2021 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) announced the formation of a strategic, public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of a range of COVID-19 combination diagnostic tests for core laboratories, hospitals and at the point of care.
As part of the collaboration, BARDA, a part of the U.S. HHS Office of the Assistant Secretary for Preparedness and Response, will award BD an initial $24.7 million under contract number 75A50121C00025 with options to extend to $40.3 million for development and FDA 510(k) clearance of five new combination tests including:
- BD Veritor Plus System Respiratory Panel – A rapid, antigen test that detects and distinguishes between SARS-CoV-2, Influenza A, and Influenza B at the point-of-care
- BD MAX System Respiratory Panel – A molecular PCR test that detects and distinguishes between SARS-CoV-2, Influenza A / B, and respiratory syncytial virus (RSV) for hospital or other moderate-throughput labs
- BD MAX System Respiratory Panel plus Pan-Coronavirus – A molecular PCR test to detect and distinguish between SARS-CoV-1, MERS, seasonal coronaviruses, and novel or emerging coronaviruses in order to address future outbreaks in hospital or other moderate-throughput labs
- BD COR System Respiratory Panel – A molecular PCR test that detects and distinguishes between SARS-CoV-2, Influenza A / B and respiratory syncytial virus (RSV) for core, reference or other high-throughput labs
- BD COR System Respiratory Panel plus Pan-Coronavirus – A molecular PCR test to detect and distinguish between SARS-CoV-1, MERS, seasonal coronaviruses, and novel or emerging coronaviruses in order to address future outbreaks in core, reference, or other high-throughput labs.
While BD has a COVID-19 and Influenza A+B combination test available under FDA emergency use authorization on both the BD MAX System and the BD Veritor Plus System, the collaboration with BARDA is designed to achieve full 510(k) clearance of the BD Veritor SARS-CoV-2 and Flu A+B — as well as develop new combination tests on other BD diagnostic platforms.