BARDA and Becton, Dickinson are collaborating to develop and achieve FDA 510(k) clearance on a range of combination COVID-19-related diagnostics that span the U.S. healthcare system.
BD (Becton, Dickinson and Company) has announced the formation of 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, 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 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:
- 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 respiratory syncytial virus (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, 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.
Covering testing in point-of-care, acute-care and high-throughput laboratory settings, these diagnostic tests 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, 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, helping to enable the right care.
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.
