Pa. company working on rapid DIY COVID-19 test
OraSure Technologies, a medical device company based in Bethlehem, plans to have a quick COVID-19 test you can do yourself by the end of the year.
The idea is to have a test that someone would be able to do themselves and get results quickly, without the need for medical training, access to a machine to interpret results, or time to transport testing materials to a lab. It would tell whether someone had the new coronavirus by testing for antigens, small structures on the surface of viruses.
“Essentially, it’s a lab on a swab,” said OraSure president and CEO Stephen Tang at a press conference.
Tang said the test is in clinical trials now, and the company plans to file for emergency use authorization from the Food and Drug Administration and get it ready by the end of the year. The company is also working on a COVID-19 antibody test that would be done at labs.
The company will get slightly more than a million dollars in state funding because they will expand manufacturing in the Lehigh Valley and create 177 jobs.
A shortage of testing machines and supplies has held up COVID-19 testing in the U.S. Last week, the Pennsylvania Department of Health said the state averaged more than 22,000 test results per day. An NPR collaboration with the Harvard Global Health Institute estimated in late June that Pennsylvania needs to be doing more than 46,000 tests per day to suppress the spread of the virus, keeping infections low enough to open public life again.
Therefore, if the OraSure rapid antigen test works as intended, it “would be a game changer,” said Pennsylvania Health Secretary Dr. Rachel Levine at a press conference.
Pennsylvania Governor Tom Wolf said “we still are looking for that holy grail of fast turnaround time and easy application” and that contact tracing and testing are key for the state.
Stephen Tang of OraSure said the company is aware of how big of a difference a reliable, quick COVID-19 test could make to places like inuring homes, schools, and prisons. He said he has an elderly uncle with special needs in a nursing home who got COVID-19 and has not been able to have visitors.
This would not be the first rapid antigen test for COVID-19. The Food and Drug Administration gave the first emergency use authorization to another rapid antigen test from the San Diego-based company Quidel back in May, but noted that antigen tests have a higher chance of false negatives, so negative results do not rule out infection and might need to be confirmed with another test. Quidel notes that their test does not distinguish between the 2003 SARS coronavirus and the new coronavirus, though there have not been any known SARS cases since 2004.
When asked why OraSure’s test would be different, Tang pointed to the company’s history of making an FDA-approved rapid home test for HIV, and a rapid test for Ebola that the FDA has allowed OraSure to market.
“Unlike most companies who are just getting started in this area of rapid tests, we have products that have been performing for years,” Tang said.
“We’re probably best known as the spit collector company used by companies like 23andMe,” Tang told WHYY’s The Pulse back in May.
Tang said OraSure plans to make the COVID-19 test something affordable that people can buy at drug stores or online, as well as use at medical providers and other places. He noted their HIV test is sold in drug stores for around $40.