NEW YORK – OraSure Technologies announced Thursday it has been awarded $13.6 million in funding from the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response Biomedical Advanced Research Development Authority, or BARDA.
The funding will support OraSure in obtaining 510(k) clearance and CLIA waiver from the US Food and Drug Administration for its InteliSwab COVID-19 rapid SARS-CoV-2 antigen test.
The InteliSwab test uses a lower nostril swab with an integrated rapid antigen assay, providing results in 30 minutes. It received Emergency Use Authorization in June for professional point-of-care, prescription home, and over-the-counter uses.
"Once received, this full regulatory clearance will help ensure continued availability of the InteliSwab COVID-19 Rapid Test long-term," said OraSure CEO Stephen Tang in a statement.
To date, there are no COVID-19 rapid antigen tests with 510(k) clearance and the requirements for such designation are expected to be more stringent than the requirements for EUA. Following 510(k) clearance, OraSure will pursue CLIA waiver for InteliSwab, "ensuring the test can continue to be performed by an untrained user outside of the laboratory setting," the firm noted.