Bethlehem-based Orasure submits rapid at-home COVID test for FDA approval

Written by on March 31, 2021

Bethlehem-based Orasure submits rapid at-home COVID test for FDA approval

By Hayden Mitman

March 31, 2021

Photo | Brittany Sweeney / WLVR

Bethlehem-based OraSure Technologies has submitted its new rapid COVID home test for U.S Food and Drug Administration emergency approval. 

Listen to the story.

Company officials say it could be a game changer. 

Coronavirus testing is tricky. Not only is it time-consuming, but it also puts people at risk of transmitting or contracting the virus. 

Stephen Tang, Orasure’s chief executive officer, says their test could change that. 

 “You can do it in the comfort of your own home. It can be administered anywhere, anytime, by practically anybody. I think that’s the innovation we’ve engineered into the product,” Tang says.

The rapid antigen test will deliver results in about 40 minutes. Tang says they’re waiting for the FDA’s evaluation before disclosing the accuracy rate. 

Orasure received more than $600,000 in federal funding to develop the test. The company had hoped to make it available late last year. 

“This is a major threshold for us. We have a lot more work to do to bring this to the marketplace. But, we are confident of our chances and very proud of our people,” Tang says.

But, Tang says, the FDA requirements changed over the development process.  

If approved, Tang says OraSure plans to get the test on the market as soon as possible. 

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