University researchers who developed the test said they don’t intend to commercialize it.
Federal officials have given emergency approval to a coronavirus saliva test that Yale University researchers used on NBA players and staff.
In a statement, Stephen Hahn, commissioner of the Food and Drug Administration, called the test “groundbreaking,” partly because it doesn’t need additional components, which have been prone to shortages, necessary with the standard nasal swab COVID-19 test.
The test, known as SalivaDirect, “is simpler, less expensive, and less invasive than the traditional method for such testing,” Yale said in a news release Saturday.
The authorization allows the test to bypass the FDA’s regular approval process.
SalivaDirect doesn’t rely on proprietary technology, and Yale researchers don’t intend to commercialize it, the university said. The researchers will provide protocols to other diagnostic laboratories that could use commercially available equipment to conduct the test, the agency said.
Nathan Grubaugh, one of the researchers who developed the test, said he expects labs to charge about $10 per sample.
“If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” Grubaugh said, according to the Yale news release.
Yale announced the study in June. The researchers partnered with the NBA because its players and on-court staff members are tested regularly, they’re in close contact with one another, and they don’t wear face coverings.
Yale said the accuracy of the results, which haven’t yet been peer-reviewed, was similar to that of nasal swab tests.