27.09      2021

OraSure Getting Up To $13.6M From Feds for COVID-19 Rapid Test 510(k) Clearance

OraSure Technologies is getting up to $13.6 million from the federal Biomedical Advanced Research Development Authority (BARDA) to help it gain the FDA’s 510(k) clearance for its InteliSwab COVID-19 rapid test.

InteliSwab is a “swab, swirl and see” test used to self-collect a sample from the lower nostrils, according to the Bethlehem, Pa.-based company. The test delivers a result on the test stick within 30 minutes.

The InteliSwab COVID-19 rapid test already has three Emergency Use Authorizations from the FDA for professional point-of-care use, prescription home use and over-the-counter use.