OraSure subsidiary’s saliva collection device now can be used in COVID-19 testing

Bethlehem’s OraSure Technologies Inc. got a stock boost Monday after it announced a Canadian subsidiary received federal authorization for a saliva-based collection device that could be used with approved COVID-19 tests.

With emergency use authorization from the U.S. Food and Drug Administration, the device can be used for self-collection of saliva specimens at home, which would then have to be taken to a lab for testing.

Some labs had already been using the device, OraSure spokesperson Jeanne Mell said, and the authorization paves the way for others to use it, as well.

“This is the first FDA EUA that allows for the unsupervised use of the device at-home or in a health care setting when used as part of an approved or validated at-home test kit, meaning patients can safely collect their own sample, without the presence of a health care professional,” OraSure said in a news release.

The OMNIgene ORAL device was developed by DNA Genotek and is used with molecular or polymerase chain reaction tests for COVID-19. There is no at-home test that the device can be used with at this time, Mell confirmed.

“The OMNigene ORAL is a component of a test that would be run in a lab,” Mell said.

The news was initially inaccurately reported in some news stories, which made it seem OraSure had gotten the permission it needed to release its rapid at-home COVID-19 test to the market.

In fact, the DNA Genotek test component is separate from OraSure’s ongoing efforts to develop a rapid antigen self-test that would detect a COVID-19 infection within minutes, and a lab-based antibody test that would detect prior infection.

Related to those efforts, OraSure is expanding in the Lehigh Valley, creating 177 full-time jobs and retaining 233 positions across three company locations in Bethlehem and one in Bethlehem Township.

On DNA Genotek’s news, shares of OraSure closed at $15.94 on Monday, up more than 15%.