NEW YORK – OraSure Technologies said on Monday it has been awarded a contract from the US Department of Defense valued at $109 million. The contract supports manufacturing scale-up for the Bethlehem, Pennsylvania firm's InteliSwab rapid SARS-CoV-2 antigen assays.
The contract, which also involved coordination with the US Department of Health and Human Services, is intended to build manufacturing capacity as part of a national pandemic preparedness plan.
In a statement, OraSure said the federal funding will expand its production capacity by 100 million tests per year by March 2024.
An existing OraSure site in Bethlehem will be retrofitted to accommodate the increased manufacturing, the firm said, and OraSure will add another US location as well. The company has also internally funded expansion plans to achieve 120 million tests annually by the second quarter of 2022.
The InteliSwab rapid antigen test — which uses a self-collected lower nostril swab sample and provides results on the test stick within 30 minutes — was granted Emergency Use Authorization from the US Food and Drug Administration in June for professional point-of-care use, prescription home use, and over-the-counter use.
"As a company, we stand ready to aid in the government's efforts to allow individuals to return to work and school safely," said Stephen Tang, OraSure's president and CEO. "Beyond that, this funding will allow OraSure to respond to future public health crises," Tang added.
OraSure was awarded a $205.2 million procurement contract from the DoD last month to purchase 20.6 million InteliSwab test kits. It was also awarded $13.6 million by the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response Biomedical Advanced Research Development Authority, or BARDA, to support the firm's efforts to obtain 510(k) clearance and CLIA waiver for the test.