Dive Brief:
- LabCorp has become the first company to receive emergency use authorization for a direct-to-consumer multi-analyte COVID-19 test from the Food and Drug Administration.
- The kit allows individuals to self-collect nasal swab samples at home to send to LabCorp, which will test for the presence of influenza A and B, respiratory syncytial virus and SARS-CoV-2. As the pathogens cause similar symptoms, a firm diagnosis can only be made by testing for the viruses.
- The FDA shared details of the emergency use authorization on the same day that LabCorp disclosed the launch of an at-home sample collection device for diabetes-risk testing. The products advance a multiyear push into direct-to-consumer testing that began in 2015.
Dive Insight:
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.
