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Becton Dickinson, BARDA Ink $40.3M Contract for Five Combo Assays

NEW YORK – Becton Dickinson announced Thursday that it has formed a public-private partnership with the Biomedical Advanced Research and Development Authority supporting the development of combination diagnostic tests for core laboratories, hospitals, and the point of care that include COVID-19 targets.

The initial award from BARDA — a division of the US Health and Human Services' Office of the Assistant Secretary for Preparedness and Response — is for $24.7 million with options to extend up to $40.3 million.

In a statement Franklin Lakes, New Jersey-based BD said the BARDA collaboration is for the development and US Food and Drug Administration 510(k) clearance of five combination tests.

These tests could be used to make treatment and management decisions, help better allocate resources in hospitals, and inform on epidemiologic trends or new and emerging viruses, BD further noted.

Dave Hickey, president of BD's Life Sciences division, commented that COVID-19 will be "with us for a long time," and the collaboration with BARDA will allow the firm to "develop a comprehensive suite of FDA-cleared tests for use at all levels of the US healthcare system."

Specifically, BD will develop a rapid point-of-care antigen test on its BD Veritor system to detect and distinguish SARS-CoV-2, influenza A, and influenza B, called the BD Veritor Plus System Respiratory Panel.

On the molecular side, BD will develop two assays on the BD Max system and two assays on the BD Cor system.

The BD Max assays are intended for use in hospitals and moderate throughput labs. The BD Max System Respiratory Panel will detect and distinguish SARS-CoV-2, flu A and B, and respiratory syncytial virus, while the BD Max System Respiratory Panel plus Pan-Coronavirus will detect and distinguish between SARS-CoV-1, Middle East Respiratory Syndrome, seasonal coronaviruses, and novel or emerging coronaviruses. The latter panel will help to address future coronavirus outbreaks, BD said.

The firm will also develop a BD Cor System Respiratory Panel and BD Cor System Respiratory Panel plus Pan-Coronavirus, which will detect and distinguish the same targets as the Max system panels but are intended for use by reference labs or high-throughput diagnostic settings.

BD has Emergency Use Authorizations for COVID-19, flu A, and flu B combination tests on both the BD Max and the BD Veritor Plus, but the firm specified that 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 to add additional targets and novel assays for the other systems.