As the pandemic coronavirus has morphed and changed in the last two and a half years on its way to becoming an endemic disease, it’s evolved to produce symptoms that look increasingly like those of other seasonal respiratory illnesses, making it difficult to distinguish between COVID-19, respiratory syncytial virus, the flu, the common cold and seasonal allergies.
The solution? Rather than taking a process-of-elimination approach and testing for each illness individually, many diagnostic developers have begun rolling out tests that can detect a handful of conditions at once—and they just became much more accessible, thanks to the FDA.
The agency handed out its first emergency authorization this week for a direct-to-consumer version of these combination diagnostics. The lucky recipient was Labcorp, with its non-prescription PCR test for catching COVID, RSV and influenza A and B.
Labcorp's Seasonal Respiratory Virus RT-PCR DTC Test requires only a single nasal swab to search for all four infections. The sample can be self-collected in a patient’s own home, then sent off to the diagnostic lab giant for processing.
Individuals will be able to buy the tests themselves online or in stores, without requiring a doctor’s orders. Once the results are delivered to Labcorp’s online portal, they’ll be offered a follow-up consultation with a healthcare provider if the results for any of the four illnesses come back positive.
The test is authorized for use by patients ages 2 and up. The samples should be collected by an adult for children between 2 and 14 and self-collected with adult supervision for those between 14 and 18.
“While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample and send it to the lab for testing, without consulting a healthcare professional,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
“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.
The authorization follows a handful of others for combination tests that do require a prescription, including offerings from Abbott, PerkinElmer, Cepheid and more.
The at-home testing win for Labcorp comes shortly after the company revamped its direct-to-consumer diagnostic options. In February, it unveiled the new Labcorp OnDemand platform, which replaces its Pixel by Labcorp service.
Through the OnDemand platform, individuals can choose between several dozen test kits that range in price from $29 to about $200. After ordering the tests themselves, they’ll either be asked to collect and send in their own sample or set up an appointment at a Labcorp patient service center to have it professionally collected.