BD receives FDA clearance for rapid point-of-care COVID-19 test

Published 30/07/2025, 12:44
BD receives FDA clearance for rapid point-of-care COVID-19 test

FRANKLIN LAKES, N.J. - BD (Becton, Dickinson and Company) (NYSE:BDX), a prominent player in the Healthcare Equipment & Supplies industry with a market capitalization of $52.27 billion, announced Wednesday it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its BD Veritor System for SARS-CoV-2, a digital antigen test that detects COVID-19 in symptomatic patients in approximately 15 minutes. According to InvestingPro analysis, the company currently trades below its Fair Value, suggesting potential upside opportunity.

The test, which has been available under Emergency Use Authorization since September 2020, will transition to the newly cleared version beginning in early fall 2025. The system is designed for use in CLIA-waived settings such as doctors’ offices, urgent care centers, and retail clinics.

According to the company’s press release, the BD Veritor System uses chromatographic digital lateral flow immunoassay technology to provide objective results through the BD Veritor Plus Analyzer. The test processes nasal swab specimens from patients within six days of symptom onset.

"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, in the statement.

The test joins BD’s portfolio of diagnostic solutions. BD employs more than 70,000 people globally and provides various medical technologies and services across healthcare sectors.

The FDA clearance represents a regulatory milestone for a test that transitions from emergency authorization to standard clearance as COVID-19 testing remains part of clinical diagnostic protocols.

In other recent news, BD (Becton, Dickinson and Company) announced the start of the first pharmaceutical-sponsored clinical trial using its BD Libertas Wearable Injector for subcutaneous delivery. This follows more than 50 pre-clinical and clinical studies conducted by BD. Additionally, the company declared a quarterly dividend of $1.04 per share, with an annual rate of $4.16 per share, payable on September 30, 2025. In a major development, BD plans to separate its Biosciences & Diagnostics Solutions division through a merger with Waters Corporation, valued at $17.5 billion. BD will receive approximately $4 billion in cash from the transaction, intending to use half for share repurchases and the rest for debt reduction. Analyst firm TD Cowen maintained its Hold rating for BD, with a price target of $183, following the strategic realignment announcement. Furthermore, BD appointed Bilal Muhsin as executive vice president and president of its new Connected Care segment, focusing on integrating advanced analytics and AI with smart devices to improve patient care.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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