NEW YORK – A 15-minute diagnostic test from Becton Dickinson to detect antigens of the SARS-CoV-2 virus has received Emergency Use Authorization by the US Food and Drug Administration.
The test, called the BD Veritor Plus SARS-CoV-2 assay, operates on the portable BD Veritor Plus Analyzer Instrument. It is authorized for high, moderate, and waived settings, which means that it can be used in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, FDA noted in a statement issued on Monday.
The BD antigen test, which the firm officially launched on Monday after securing EUA on July 2, is the second coronavirus antigen test that FDA has granted EUA, following Quidel's Sofia 2 SARS Antigen FIA in May.
Other antigen tests in development include an oral fluid test from OraSure tracking for a fall 2020 launch. The World Health Organization is also seeking $6 billion to support viral antigen test research, development, and scale-up for global use.
Stephen Hahn, FDA's commissioner, commented in a statement on Monday that expanding US testing capabilities is the result of a partnership between the federal government, the private sector, and academia. "Today’s authorization is another achievement of that work," Hahn said, noting that antigen tests play an important role in the overall response against COVID-19, "including as a point-of-care test that can potentially scale up to test millions of Americans quickly."
BD said in a statement that the Veritor antigen test is critical for improving access to COVID-19 diagnostics because it enables real-time results and decision making while a patient is still onsite.
The Veritor System is slightly larger than a cell phone, the firm said, and is currently in use at more than 25,000 hospitals, clinician offices, urgent care centers, and retail pharmacies in all 50 US states.
BD expects to produce up to 10 million tests from July through September and is scaling up to produce 2 million tests per week by the end of September.
The new assay joins three other COVID-19 tests that have been registered for use with the BD MAX Molecular System, including two with EUAs and two with the CE mark.
BD said it intends to pursue 510(k) clearance for the BD Veritor Plus SARS-CoV-2 assay from the FDA at a later time.
Brian Weinstein, an analyst at William Blair, said in a note to investors that the stated sensitivity of the BD test was 84 percent and its specificity 100 percent, "which we believe is sufficient for broad use and is a touch below that of Quidel."
The demand for antigen testing is "building very quickly," Weinstein said, adding that this type of testing "should gain significant traction in coming weeks and months given the rapid nature of the testing, decentralized capabilities, adequate sensitivity — in line with the roughly 40 million influenza tests done in the United States every year — and data management capabilities that allow for real-time monitoring of outbreaks."
Vijay Kumar, an Evercore ISI analyst, wrote that despite the test's low sensitivity — albeit still above the 80 percent threshold set by FDA for antigen tests — "we think the new antigen test will play a big role in the coming flu season as a rapid, rule-out test [due to the] 100 percent specificity." He added that the ease of use and location advantages differentiate the system "and will provide another tool kit for managing COVID cases without burdening the hospital system."
BD's stock on the Nasdaq was fairly flat following the launch, closing at $79.40 on Monday, but jumped nearly 38 percent to open at $109.38 Tuesday morning.