BARDA and BD (Becton, Dickinson and Company) are collaborating to develop and achieve US Food and Drug Administration (FDA) 510(k) clearance on a range of combination COVID-19-related diagnostics that span the U.S. healthcare system.
These diagnostics include the BD Veritor Plus System Respiratory Panel, the BD MAX System Respiratory Panel, the BD MAX System Respiratory Panel plus Pan-Coronavirus, the BD COR System Respiratory Panel, and the BD COR System Respiratory Panel plus Pan-Coronavirus. These diagnostic panels cover testing in point-of-care, acute-care, and high-throughput laboratory settings.
Each test provides the ability to screen for multiple pathogens in a single sample taken from a person with the signs and symptoms of a respiratory illness. The BD Veritor Plus System Respiratory Panel detects and distinguishes between antigens of SARS-CoV-2, Influenza A, and Influenza B at the point-of-care. The BD MAX System Respiratory Panel and the BD COR System Respiratory Panel have broader coverage, detecting and distinguishing between the nucleic acid of SARS-CoV-2, Influenza A, Influenza B, and respiratory syncytial virus (RSV). The BD MAX System Respiratory Panel plus Pan-Coronavirus and BD COR System Respiratory Panel plus Pan-Coronavirus tests add the capability 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. The BD MAX and BD COR Systems are for use in moderate-throughput and high-throughput settings, respectively.
By determining the causative agent, the tests can aid health care providers in making more informed decisions about patient health management, as well as the management of health care resources. These tests can enable decisions on whether a person with COVID-19, influenza, or another respiratory illness should be admitted to a hospital, receive COVID-19 antibody therapeutic 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 also provide the capability to detect novel or emerging coronaviruses that may lead to the next pandemic. The development and clearance of the BD MAX and COR Systems tests with and without Pan-Coronavirus provides end-users with options that best fit their use-case.
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit www.bd.com or connect with us on LinkedIn at http://www.linkedin.com/company/bd1/ and Twitter bdandco.