BARDA renews collaboration with OraSure Technologies to support InteliSwab™ COVID-19 Rapid Test 510(k) Clearance and CLIA Waiver
BARDA and OraSure Technologies, Inc. are partnering again, this time to advance their rapid antigen test for SARS-CoV-2 to U.S. Food and Drug Administration (FDA) 510(k) clearance.
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.
BARDA supported development of the OraSure InteliSwab test from inception through Emergency Use Authorization (EUA) for over-the-counter (InteliSwab COVID-19 Rapid Test), prescription home use (InteliSwab COVID-19 Rapid Test Rx), and professional point-of-care use (InteliSwab COVID-19 Rapid Test Pro). These tests received EUA in June 2021.
The 510(k) clearance and CLIA waiver for this test will ensure InteliSwab continues to be available on the market even after the public health emergency is declared over.
The InteliSwab test targets the detection of all clinically relevant SARS-CoV-2 variants of concern, as qualified by the U.S. Centers for Disease Control and Prevention (CDC). Currently there are no rapid point-of-care antigen tests available with 510(k) clearance.
DoD Procures InteliSwab COVID-19 Rapid Tests for Nearly 25,000 Sites
The Defense Logistics Agency earlier this month awarded OraSure a procurement contract for its InteliSwab™ COVID-19 Rapid Test for over-the-counter use, which the Defense Logistics Agency estimated to have a value of $205 million.
Under the terms of the contract, OraSure will provide its InteliSwab™ COVID-19 Rapid Test to up to 25,000 sites throughout the United States as part of the National pandemic response and the tests will be funded by the U.S. federal government. The contract will run from October 2021 through September 2022.