FLC | At-home COVID-19 test from federal partner OraSure earns amended EUA for single use

At-home COVID-19 test from federal partner OraSure earns amended EUA for single use

November 2, 2021

Federal partner OraSure Technologies announced on November 2 that the emergency use authorization (EUA) for its InteliSwab™ COVID-19 rapid tests has been amended by the U.S. Food and Drug Administration (FDA) to only require one test for individuals with symptoms of COVID-19.

The at-home test, developed with funding support from the Biomedical Advanced Research and Development Authority (BARDA), previously was authorized for over-the-counter use in people with or without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests, which is called serial testing. Now, people with symptoms only need to test once; people without symptoms should still perform serial testing if they get a negative result on their first test.

In addition, OraSure conducted studies using live SARS-CoV-2 virus at independent laboratories that showed detection of all variants of concern, including the Delta variant. The FDA reviewed the data submitted by OraSure regarding the detection of the SARS-CoV-2 Delta variant and indicated that the data were adequate, and that no further data are required.

“These studies in independent labs clearly show the InteliSwab tests detect variants, including the Delta variant that roared through the country late this summer, and this should give people extra confidence in the accuracy of InteliSwab,” said OraSure President and CEO Stephen Tang, PhD. “Beyond that, the authorization of the InteliSwab COVID-19 Rapid Test to be used as a one-time, over-the-counter test for people with COVID-19 symptoms will help increase our nationwide availability of tests, ensuring people who want rapid tests have access to them.”

The EUA amendment comes less than a month after OraSure announced that it had been awarded a $109 million contract from the U.S. Department of Defense (DOD), in coordination with the Department of Health and Human Services (HHS), to build additional manufacturing capacity in the United States for InteliSwab™ COVID-19 rapid tests as part of the nation’s pandemic preparedness plan.

InteliSwab was granted three EUAs by the Food and Drug Administration (FDA) in June 2021 for professional point-of-care use, prescription (Rx) home use, and over-the-counter (OTC) use.