“Essentially, it’s a lab on a swab,” said Stephen Tang, president and CEO of OraSure Technologies in Bethlehem. “(It) would quickly detect active COVID-19 infection at the point of sample collection.”
Unlike other rapid antigen tests available, Tang said OraSure’s test can be done without any other equipment or without sending a sample to a lab, ensuring immediate results.
Other antigen tests on the market have been criticized for unreliable results, but Tang said his company has a history of developing dependable tests.
“Our HIV in-home test is the only FDA-approved test for an infectious disease that you could buy in a drugstore or online,” he noted. “The sensitivity or specificity of that test is in the high 90s.”
Tang didn’t offer a specific price for the coronavirus test, but he said it will be affordable. They’re working on qualifying the test for reimbursement from health insurance providers to help with the cost.
If the FDA approval goes as he hopes, Tang said they could produce 55 million total tests by the end of the first quarter of 2021. With state grants and tax credits, they could ramp up significantly — up to 70 million — by the end of the second quarter.
Tang joined Pennsylvania Gov. Tom Wolf and state Health Secretary Dr. Rachel Levine on Tuesday, who said the rapid at-home tests could be a game-changer for all parts of the economy, but especially for nursing homes and schools.
“Pending regulatory approvals and launch, individuals would be able to obtain the test, take on their own, and read their own results in a short time,” said Tang. “It will come to the market in very attractive ways.”