The federal government plans to pay up to up to $40.3 million to BD (Becton, Dickinson and Company) for the development of up to five combination COVID-19 tests.
The award is being made through the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. The funds will 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 will award BD an initial $24.7 million with options to extend to $40.3 million for development and 510(k) clearance from the U.S. Food and Drug Administration for five tests including:
- A BD Veritor Plus System Respiratory Panel, which is a rapid, antigen test that detects and distinguishes between SARS-CoV-2, Influenza A and Influenza B at the point-of-care
- A BD MAX System Respiratory, which is a molecular PCR test that detects and distinguishes between SARS-CoV-2, Influenza A, Influenza B and respiratory syncytial virus (RSV) for hospital or other moderate-throughput labs
- A BD MAX System Respiratory Panel plus Pan-Coronavirus, which is a molecular PCR test to detect and distinguish between SARS-CoV-1, Middle East Respiratory Syndrome (MERS), seasonal coronaviruses, and novel or emerging coronaviruses to address future outbreaks in hospital or other moderate-throughput labs
- A BD COR System Respiratory Panel, which is a molecular PCR test that detects and distinguishes between SARS-CoV-2, Influenza A, Influenza B and respiratory syncytial virus (RSV) for core, reference or other high-throughput labs
- A BD COR System Respiratory Panel plus Pan-Coronavirus, which is a molecular PCR test to detect and distinguish between SARS-CoV-1, Middle East Respiratory Syndrome (MERS), seasonal coronaviruses and novel or emerging coronaviruses in order to address future outbreaks in core, reference or other high-throughput labs.
The addition of Pan-Coronavirus tests on the BD MAX and BD COR Systems would also provide the capability to detect novel or emerging coronaviruses.
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 to help ensure availability and access to critical diagnostic tests even after the COVID-19 pandemic emergency is declared to be over.
