On Sept. 23, 2021, OraSure Technologies and the Biomedical Advanced Research Development Authority (BARDA) announced up to $13.6 million in funding for the Company to obtain 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for OraSures InteliSwab COVID-19 rapid test from the Food and Drug Administration (FDA).

InteliSwab™ is a simple “swab, swirl, and see” test that uses an integrated swab to self-collect a sample from the lower nostrils. The result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed. It has three Emergency Use Authorizations from the Food and Drug Administration for professional point-of-care use, prescription (Rx) home use, and over-the-counter (OTC) use.

The InteliSwab™ COVID-19 Rapid Test is authorized for emergency use for the duration of the public health declaration. With FDA 510(k) clearance, InteliSwab™ can continue to be marketed without a public health emergency declaration from the Secretary of the Department of Health and Human Services (HHS). To date, there are no COVID-19 rapid antigen tests with 510(k) clearance and the requirements for 510(k) clearance are expected to be more stringent than the requirements for EUA.