A partnership between BD, formally Becton, Dickinson and Co., and the Biomedical Advanced Research and Development Authority, part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response, was announced Thursday that will develop of a range of COVID-19 combo diagnostic tests for core laboratories, hospitals and at the point of care.
BARDA will award BD an initial $24.7 million with options to extend to $40.3 million for development and FDA 510(k) clearance of five new combination tests.
“We know that COVID-19 will be with us for a long time, and we share BARDA’s desire to help ensure the U.S. health care system is ready to diagnose and ultimately treat known and emerging respiratory viruses,” Dave Hickey, president of life sciences for BD, said in a prepared statement. “This collaboration will allow us to develop a comprehensive suite of FDA-cleared tests for use at all levels of the U.S. health care system to detect COVID-19, other respiratory pathogens and emerging coronaviruses in order to inform appropriate patient response and management.”
The five new combination tests include:
- A 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;
- A BD MAX System Respiratory Panel: A molecular PCR test that detects and distinguishes between SARS-CoV-2, Influenza A, Influenza B and respiratory syncytial virus for hospital or other moderate-throughput labs;
- A BD MAX System Respiratory Panel plus Pan-Coronavirus: A molecular PCR test to detect and distinguish between SARS-CoV-1, Middle East Respiratory Syndrome, seasonal coronaviruses and novel or emerging coronaviruses in order to address future outbreaks in hospital or other moderate-throughput labs;
- A BD COR System Respiratory Panel: A molecular PCR test that detects and distinguishes between SARS-CoV-2, Influenza A, Influenza B and respiratory syncytial virus for core, reference or other high-throughput labs; and
- A BD COR System Respiratory Panel plus Pan-Coronavirus: A molecular PCR test to detect and distinguish between SARS-CoV-1, Middle East Respiratory Syndrome, seasonal coronaviruses and novel or emerging coronaviruses in order to address future outbreaks in core, reference or other high-throughput labs.
In addition to providing the capability to better manage patient health and health care resources, 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.
