OraSure Technologies, Inc. announced that its InteliSwab COVID-19 rapid tests detect the Omicron variant as effectively as they detect the original SARS-CoV-2 strain and other previous variants of concern, including Delta, Alpha, Beta and Gamma. The Omicron variant studies were conducted using live SARS-CoV-2 virus at an independent, third-party laboratory and showed InteliSwab detected the Omicron variant at the same viral load levels, or limit of detection, as previous variants that were tested. Testing with InteliSwab is simple: users swab their lower nostrils with the test stick, swirl it in a pre-measured solution, and see their result on the test stick in 30 minutes – with no instruments, batteries, smartphone or laboratory analysis needed to see the result.

With less than one minute of “hands-on time,” it is as simple as “Swab, Swirl, and See.” About InteliSwab: OraSure has received Emergency Use Authorizations (EUA) from the FDA for its InteliSwab COVID-19 rapid tests. The FDA has authorized the InteliSwab COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. The FDA has also authorized the InteliSwab COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and the InteliSwab COVID-19 Rapid Test Rx for Prescription Home Use.

These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. InteliSwab's unique design incorporates a built-in swab fully integrated into the end of the test stick. This product has not been FDA cleared or approved, but it has been authorized by the FDA under an EUA.

The emergency use of this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Multiple government agencies, including the U.S. Department of Defense (DoD) and Department of Health and Human Services (HHS) are working to address COVID-19 testing needs.

Development of the InteliSwab COVID-19 Rapid Test has been funded in whole or in part with federal funds from the HHS; the Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research, Innovation and Ventures under contract number 75A50120C00061, utilizing Health Care Enhancement Act (HCEA) funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the manufacturing expansion effort for the InteliSwab COVID-19 rapid test in coordination with the Department of the Air Force's Acquisition COVID-19 Task Force (DAF ACT). This effort was funded through the American Rescue Plan Act (ARPA) to enable and support domestic industrial base expansion for critical medical resources.