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BD collects full FDA clearance for ‘tripledemic’ infection test

August 6, 2023
Life sciences

After receiving one of a dwindling number of COVID-era FDA emergency authorizations earlier this year, BD has converted its combination respiratory virus test to a full regulatory green light.

The molecular panel—which screens for COVID-19, respiratory syncytial virus and influenza A and B from a single swab—is designed to deliver a result in two hours using the company’s automated BD MAX tabletop analyzer.

With the upcoming flu season this winter in the Northern Hemisphere, BD aims to provide a co-testing approach during a time that has seen rising cases of RSV while COVID continues to be endemic.

“Last year, we experienced a threat of a ‘tripledemic’ with COVID, flu and RSV circulating simultaneously, and that threat remains for the coming respiratory season,” Nikos Pavlidis, BD’s VP and general manager for diagnostics, said in the company’s announcement.

“As patient symptoms and clinical presentation can be nearly identical, a combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients, and help manage the spread of the infections,” Pavlidis said.

The panel previously received an Emergency Use Authorization in February; BD said it would discontinue the EUA version and replace it with one granted a full 510(k) clearance by the FDA, which allows it to be sold after the end of the agency’s public health emergency authority.

The company said there would be no gaps in the availability of the test. In the European market, the respiratory virus panel previously obtained a CE Mark in May 2022.

COVID-19 diagnostics revenue has dropped precipitously this year for testmakers across the industry—with sales drops taking a bite out of companies’ quarterly earnings and major players like Quest Diagnostics predicting an 80% drop in coronavirus-related income during 2023.

For the second quarter of BD’s fiscal calendar, which ended March 31, the company reported just $16 million in COVID-only test sales—after topping more than $400 million per quarter during the 2020 highs of the pandemic—and BD said it expects to only make a total of $50 million for the full year of 2023. The company’s third-quarter earnings release is scheduled for Aug. 3.

By Conor Hale


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