A Covid-19 test that processes saliva samples and does not require special swabs or collection devices received emergency-use authorization by the U.S. Food and Drug Administration on Saturday. SalivaDirect test is expected to be priced at $10 per sample. Cheap, fast saliva-based test could boost testing frequency.
Research for the test was done by Yale University’s School of Public Health and was partly funded by the National Basketball Association and the union representing NBA players.
The rapid detection test, known as SalivaDirect, “is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” FDA Commissioner Stephen Hahn said in a statement.
The FDA says while it has seen “variable performance” in tests using saliva, Yale’s test is accurate enough to meet the criteria for emergency authorization based on data submitted.
Yale plans to provide the test protocol to interested labs under an “open-source” arrangement that doesn’t rely on any proprietary equipment from Yale, according to the FDA. The Yale researchers said they aren’t seeking to commercialize the method, according to the university’s website.
While this is the fifth test that the FDA has authorized that uses saliva as a sample for testing, it may be the “lowest cost test to hit market with ability to be pooled,” Scott Gottlieb, former head of the U.S. Food and Drug Administration, said in a tweet on Aug. 8. The research team at the Yale School of Public Health expects labs to charge about $10 per sample. A low-cost test will make possible frequent testing of people, an important step as businesses, schools and companies plan to reopen.
By Yueqi Yang. Bloomberg
August 15, 2020, 5:40 PM EDT