The Middletown Press (Middletown, CT)
Feds OK use of new saliva-based COVID test developed by Yale
NEW HAVEN — A new saliva-based test for the coronavirus developed by Yale scientists has been granted an emergency-use authorization by the U.S. Food and Drug Administration, according to the agency.
The testing method, termed SalivaDirect, has been used so far to test asymptomatic players and staff from the National Basketball Association, Yale officials said.
Results have been similar to those obtained through the traditional nasal-based test, officials said, and it has been “validated with reagents and instruments from multiple vendors,” which could defray supply-chain issues that have limited testing across the country.
Through the authorization from the FDA, the tests are “immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation — and, perhaps, beyond — in the coming weeks,” researchers said.
“This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow who led the laboratory development and validation effort along with Doug Brackney, an adjunct assistant clinical professor.
“This started off as an idea in our lab soon after we found saliva to be a promising sample type ... and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus.”
Nathan Grubaugh and Anne Wyllie, assistant professor and associate research scientist, respectively, at Yale School of Public Health, led the development of the new test in recent months.
“With saliva being quick and easy to collect, we realized it could be a game-changer in COVID-19 diagnostics,” said Wyllie in a statement.
“Wide-spread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample,” said Grubaugh.
Grubaugh and Wyllie discussed the development of the new test with the Register earlier this week.