OraSure Receives Funding from BARDA to Support InteliSwab Clearance and CLIA Waiver

OraSure Technologies Inc., a leader in point-of-care and home diagnostic testing and sample collection technologies, has announced that the Biomedical Advanced Research Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), will provide up to $13.6 million in funding for the Company to obtain 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for OraSure’s 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.
 
“Rapid COVID-19 antigen tests can help to facilitate containment and minimize outbreaks by detecting those individuals infected with COVID-19. Testing with InteliSwab is expected to be an important component of governments’, private industries’ and communities’ response to the COVID-19 pandemic, along with vaccination and protection,” said OraSure president and CEO, Stephen Tang, Ph.D. “Once received, this full regulatory clearance will help ensure continued availability of the InteliSwab COVID-19 Rapid Test long-term.”

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.

Following 510(k) clearance, the company will pursue Clinical Laboratory Improvement Amendments (CLIA) waiver for InteliSwab, ensuring the test can continue to be performed by an untrained user outside of the laboratory setting.

This project has been funded in whole or in part with federal funds from BARDA, part of the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response under contract number 75A50120C00061.