Going into the first winter of the pandemic, multiple companies introduced products that tested for both influenza and COVID-19 in the expectation that the winter flu season may cause a surge in people presenting with symptoms that could be caused by either pathogen. They pitched the products as a way to ensure the timely diagnosis and treatment of the right virus.
However, unusually low flu activity in the 2020-21 season meant the misdiagnosis risk was smaller than feared. Still, companies have continued to innovate, with Roche getting a CE mark for a rapid antigen test for influenza and COVID-19 in January.
LabCorp added a new product to the U.S. testing arsenal this week by securing an EUA for a home sample collection kit that can be bought online or in a store without a prescription. The kit allows consumers to collect nasal samples for sending to LabCorp for testing. The company will test the sample for influenza A and B, RSV and SARS -CoV -2 and provide results through an online portal.
Other businesses also have received EUAs for panels that test for a range of respiratory pathogens, including those covered by LabCorp’s kit. Luminex secured an EUA for its product more than a year ago and at least four other companies have received emergency authorizations for respiratory panels since then.
LabCorp’s kit is differentiated as it enables at-home sample collection without a prescription. However, Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, already is looking forward to the next advance.
“The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home,” Shuren said in a statement.
LabCorp’s new test will slot into its dwindling COVID-19 business. In the first quarter, LabCorp averaged about 70,000 PCR tests a day, well below its 300,000 daily capacity, and COVID-19 testing sales fell 43% compared to last year.
The company expects volumes to fall for the rest of the year, while it maintains the ability to process 300,000 samples a day “pending supplies and labor” in case a new wave happens.
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As it's typically safer to discontinue the use of a drug than an implant, it "might be reasonable" to hold some devices to higher standards, suggests Ariel Wampler, author and plastic and reconstructive surgery physician.
AdvaMed backed the nomination, noting a new Medicare rule that gives developers of FDA-designated breakthrough devices the potential to sell them and be reimbursed on the day of market approval.
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