To support the development of a range of COVID-19 diagnostics, BD (Becton, Dickinson and Company), a global medical technology company, has entered into a strategic, public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response. The tests will be intended for core labs, hospitals, and point-of-care locations.
As part of the collaboration, BARDA will award BD an initial $24.7 million under contract number 75A50121C00025 with options to extend to $40.3 million for development and U.S. Food and Drug Administration (FDA) 510(k) clearance of five new COVID-19 diagnostics including:
- 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 (RSV) 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 (MERS), 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 RSV 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, MERS, seasonal coronaviruses, and novel or emerging coronaviruses in order to address future outbreaks in core, reference, or other high-throughput labs.
Covering testing in point-of-care, acute-care, and high-throughput laboratory settings, these COVID-19 diagnostics aim to provide the ability to screen for multiple pathogens in a single sample taken from a person with the signs and symptoms of a respiratory illness. By determining the causative virus, the company notes, these tests would aid health care providers in making more informed decisions about treating patients, the management of health care resources, and provide information on epidemiologic trends or new emerging viruses. These tests would also enable decisions on whether a person with COVID-19, influenza, or another respiratory illness should be admitted to a hospital, receive treatments as an outpatient, or simply be sent home to recuperate.
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. The development and clearance of BD MAX System and BD COR System tests with and without pan-coronavirus provides health care providers with options that best suit their patients, according to the company.
“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. healthcare system is ready to diagnose and ultimately treat known and emerging respiratory viruses,” says Dave Hickey, president of Life Sciences for BD. “This collaboration will allow us to develop a comprehensive suite of FDA-cleared tests for use at all levels of the U.S. healthcare system to detect COVID-19, other respiratory pathogens, and emerging coronaviruses in order to inform appropriate patient response and management.”
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.
For more information, visit BD.
Featured Image: BD has announced the formation of a strategic, public-private partnership with BARDA to support the development of a range of COVID-19 combination diagnostic tests for core laboratories, hospitals, and at the point of care. Devices pictured include the BD COR System (top), the BD Veritor Plus System (bottom left) and the BD MAX System (bottom right). Photo: BD