HHS Announces Actions to Expand Access to OTC COVID-19 Tests

The U.S. Department of Health and Human Services (HHS) is taking several new actions to help reduce costs for COVID-19 testing, expand access to tests, and bring more tests to market in the U.S.

The National Institutes of Health (NIH) is investing $70 million from the American Rescue Plan Act (ARPA) to bring more high-quality, at-home COVID-19 tests onto the market in the U.S., in coordination with the U.S. Food and Drug Administration (FDA). NIH’s new Independent Test Assessment Program (ITAP) will establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing. The program is an extension of the NIH Rapid Acceleration of Diagnostics (RADx) initiative.

Under the new program, NIH, FDA, and other CDC and HHS experts will assess and conduct studies on over-the-counter (OTC) tests and work with companies to compile proper data, work toward benchmarks for performance, and support other needs to ensure successful regulatory review submissions to the FDA. According to HHS, the goal of this initiative is to accelerate the availability of more high-quality, accurate, and reliable OTC tests to the public as quickly as possible.

Separately, the FDA is streamlining the regulatory pathway for manufacturers to develop OTC at-home tests. FDA has issued recommendations for labeling updates to facilitate OTC single-use testing for symptomatic individuals for tests currently authorized only for serial testing. Developers of these specific tests will now be able to request authorization to add single-use testing for symptomatic individuals without submitting additional data.

Additionally, FDA announced it has authorized another OTC rapid antigen test. The FDA has granted an emergency use authorization (EUA) to Celltrion Diatrust for its COVID-19 Home Ag Test for OTC single-use testing for symptomatic adults and OTC serial testing for all adults. The latest EUA issued brings the total count to 10 at-home COVID-19 tests authorized by the FDA.

Additional information from HHS is available here.