BD Wins FDA Nod for Rapid, Point-of-Care COVID-19 Test

BD (Becton, Dickinson and Company) has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Veritor system for SARS-CoV-2.

The digital test was designed to spot COVID-19 antigens in symptomatic people in about 15 minutes at doctors’ offices, urgent care centers, retail clinics, and other convenient points of care. Veritor for SARS-CoV-2 has been available under Emergency Use Authorization (EUA) from the FDA since September 2020.

The 510(k) clearance will eventually replace the current EUA version of the test beginning in early fall 2025.

The test is a chromatographic, digital lateral flow immunoassay that the company said generates objective, easy-to-read results using the Veritor Plus analyzer. It’s meant for use in CLIA-waived environments and provides results from patient nasal swab specimens within six days of the onset of symptoms.

“This FDA clearance is part of our ongoing commitment to support health care providers with reliable, rapid diagnostic tools,” said Nikos Pavlidis, worldwide president of BD Diagnostic Solutions. “The BD Veritor System for SARS-CoV-2 has proven to be a reliable COVID-19 test with a streamlined workflow and clear digital results, helping clinicians make confident and timely decisions that can help improve patient outcomes.”

Earlier this month, the company began a $17.5 billion merger deal to combine its Biosciences & Diagnostic Solutions business with Waters Corp.