FDA authorizes first non-prescription test for COVID-19, flu, RSV
The Food and Drug Administration authorized the first non-prescription COVID-19 test that can also detect the flu and RSV, the agency announced on Monday.
Driving the news: In addition to COVID-19, the test can detect other respiratory viruses, including influenza A and B, commonly known as the flu, and respiratory syncytial virus, also known as RSV.
- With the newly authorized test from Labcorp, individuals can collect their own nasal swab at home and send the sample to Labcorp for testing. They can then access their results through an online portal, with a health care provider following up about positive or invalid results.
What they're saying: "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 health care professional," Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
- "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," he added.
The big picture: COVID-19 has sparked progress within the home diagnostics industry.
- Rapid at-home tests for COVID-19, such as Abbott's BinaxNow rapid test, are now widely available.
- Health tech company Detect received emergency authorization in October 2021 for its at-home COVID-19 test, which delivers PCR-quality results.
Go deeper: The at-home health testing boom