Bethlehem-based OraSure gets emergency approval to bring over-the-counter COVID-19 test to market

Written by on June 8, 2021

Bethlehem-based OraSure gets emergency approval to bring over-the-counter COVID-19 test to market

By Hayden Mitman

June 8, 2021

The new over-the-counter COVID-19 test OraSure now has the approval to produce. Photo| Courtesy of OraSure Technologies.

Bethlehem-based OraSure Technologies has received emergency approval from the Food and Drug Administration for its long-awaited at-home coronavirus testing kits. 

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The over-the-counter test promises results in 30 minutes. 

After 15 months of work, the company is ready to bring its over-the-counter COVID-19 test to market.

Stephen Tang, Orasure’s president, chief executive officer and chairman of its board of directors, says it won’t be long before the tests are in stores. 

“I think it will be in the hands of the average person in the matter of a few weeks,” Tang says.  

The kits will be marketed under the name, InteliSwab, and will be available by prescription, in order to be covered by insurance. A version also will be sold in bulk for healthcare providers. 

Testing is still important, Tang says, even as more people get vaccinated.

“The more complacent people get, the better chance the virus has to recirculate. That’s why testing will continue to be a part of what we do,” he says.  

The swabs are easy to use and have only a 16% chance of a false positive, he says.

“We are as accurate as all the other tests out there, but we are easier to use,” Tang says.

The InteliSwab is the sixth over-the-counter COVID test on the market, he says. OraSure aims to produce 55 million units annually and plans to ramp up production to 70 million a year by the fall. 

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