Dive Brief:
- The Food and Drug Administration has cleared the first over-the-counter COVID-19 antigen test via a traditional premarket review pathway.
- Acon Laboratories secured the 510(k) clearance for its Flowflex COVID-19 Antigen Home Test. The firm received emergency use authorization (EUA) in 2021 and, by following in the footsteps of Cue Health’s de novo molecular test, converted that approval into a conventional clearance.
- The clearance gives Americans another fully authorized test ahead of an infectious respiratory disease season in which testing volumes are forecast to be down compared to prior years.
Dive Insight:
The EUA program enabled the FDA to quickly make COVID-19 tests available in the U.S. during the public health emergency. Today, the administration maintains EUAs on 65 antigen tests and 276 molecular diagnostic tests for COVID-19. While the EUAs remain in effect, the FDA is encouraging manufacturers to transition to its normal pathways now that the acute phase of the crisis is over.
Cue received a full authorization for its molecular nucleic acid amplification test in June. As part of Cue’s de novo process, the FDA created special controls to enable other companies to bring tests to market via the 510(k) pathway. Acon is the second company to get FDA authorization of a home COVID-19 test through a traditional review process.
Acon received the FDA clearance after showing its Flowflex test correctly identified 89.8% of positive and 99.3% of negative samples in people with signs and symptoms of upper respiratory infection. The clearance covers testing in children aged two years and up, differentiating Acon from Cue, which is only authorized to test in adults.
Falling demand for COVID-19 tests raises questions about whether either Acon or Cue can generate significant sales. Cue, which sells a cartridge-based testing system, reported revenues of $17.5 million for the third quarter. Other companies are dialing down their sales forecasts, with Siemens Healthineers assuming its antigen tests will make no contribution to revenues over the coming year.