ANNOUNCEMENT 28 Oct 2021

In October 2021, BARDA announced collaborating with BD (Becton, Dickinson and Company) to advance COVID-19 related diagnostics.

NUMBER OF INTERVENTIONS

1

  • 1 harmful
  • 0 neutral
  • 0 liberalising

SOURCE

U.S. Medical Countermeasures, Newsroom, “BARDA and BD collaborate on diagnostic testing to address COVID-19, influenza, and novel and emerging coronaviruses”. Available at: https://www.medicalcountermeasures.gov/newsroom/2021/bd/

Inception date: 28 Oct 2021 | Removal date: open ended

State aid, unspecified

On 28 October 2021, Biomedical Advanced Research and Development Authority (BARDA) announced collaborating with BD (Becton, Dickinson and Company) to obtain 510(k) clearance on a range of COVID-19-related diagnostics from U.S. Food and Drug Administration (FDA). For this purpose, BARDA provided USD 24.8 million.

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 tests enable to diagnose multiple pathogens in a single sample taken from a person showing symptoms of a respiratory illness.

In order to legally market a device in the US, several types of premarket submissions shall be made to the FDA. 510(k) submission is one of the submissions made to the FDA for those who want to market Class I/II/III devices in the U.S.

Part of the U.S. Department of Health and Human Services (HHS), BARDA supports the development of medical countermeasures such as vaccines, drugs, and diagnostics from research to advanced development through public-private partnerships. Support from BARDA to companies can be in various forms including funding, technical assistance and other core services. The present announcement didn’t include the type of contribution from BARDA, “state aid, unspecified” is selected as the intervention type.

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