U.S. consumers may already be familiar with Roche’s rapid antigen test for COVID-19. The mass-produced, at-home screener was distributed to tens of millions of people through the mail this year via the government’s free testing initiative.
Now, people will be seeing the Roche tests on pharmacy shelves. Rebranded as the Pilot test, the new name carries added meaning: it’s Roche’s first over-the-counter diagnostic to enter the U.S. market. Produced by the Korean test manufacturer SD Biosensor, it has also been available through digital storefronts from Amazon and Optum, but now it will also be stocked at CVS Pharmacy locations nationwide.
The FDA first issued an emergency authorization for the 20-minute test in December 2021. Designed for users 14 years and up to self-test, the nasal swab can also be adopted for children as young as 2 when an adult performs the test, the company explained in its press release announcing the Pilot brand launch.
At the top of this year, the Biden administration expanded its home testing push to include 1 billion diagnostic kits—sourced from multiple manufacturers including Roche, Abbott and iHealth among others—all offered free upon request through the government’s COVID website and delivered by the U.S. Postal Service. But after federal dollars and the stockpile of tests dried up, the program was suspended in early September.
Still, the CDC still recommends an at-home COVID test when a person is showing symptoms or after a known exposure to the coronavirus. A negative result should be followed up within 48 hours by a second test for a more solid confirmation, according to the FDA.
According to Roche, the Pilot test demonstrated a false-negative rate of 6.8% in a clinical study, alongside zero false-positive results. The company has sold more than 1.8 billion COVID-19 tests worldwide since the start of the pandemic, including lab-based molecular diagnostics and antibody tests.