The U.S. Food and Drug Administration (FDA) has announced emergency approval of a COVID-19 saliva test that was used by the researchers of the Yale University on NBA players and staff.
FDA Commissioner Dr. Stephen Hahn called the coronavirus saliva test “groundbreaking,” partly because it does not require any additional components that are needed with the standard nasal swab test.
In a news release Saturday, Yale said, “The test, called SalivaDirect, is simpler, less expensive, and less invasive than the traditional method for such testing.”
The emergency authorization allows SalivaDirect to bypass the regular approval process of the FDA.
The COVID-19 saliva test does not rely on proprietary technology, the university said, adding that the researchers do not intend to commercialize it.
The FDA said, “The researchers will provide protocols to other diagnostic laboratories that could use commercially available equipment to conduct the test.”
Prof. Nathan Grubaugh of Yale School of Public Health said he expects labs to charge around $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,” said Prof. Grubaugh, one of the researchers who developed the saliva test.
In June, Yale announced the trial of the new test. The university teamed up with the NBA because its players and staff are tested regularly. Also, the players and staff are in close contact with each other and they do not wear facemasks.
The accuracy of the results of SalivaDirect, which has not yet been peer-reviewed, was similar to the results of nasal swab COVID-19 tests.
Worldwide, the virus has affected more than 21 million people and killed over 773,000 so far. The United States health officials have reported over 5 million confirmed cases, with more than 173,000 deaths.
