A COVID-19 test that processes saliva samples and doesn't require special swabs or collection devices received emergency-use authorization by the U.S. Food and Drug Administration (FDA) on Saturday (August 15, 2020).
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.
'Open-source' arrangement
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 the market with the ability to be pooled," Scott Gottlieb, former head of the U.S. Food and Drug Administration, said in a tweet on August 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.
Saliva test for cancer
It's not the first time saliva has been used to test for diseases. In 2010, Japanese and US universities had jointly developed a medical technique that can quickly detect various cancers using a simple saliva test.
Japan's Keio University and the University of California, Los Angeles, have developed the technology with which they detected high probabilities of pancreatic cancer, breast cancer and oral cancer.
The researchers analyzed saliva samples of 215 people, including cancer patients, and identified 54 substances whose presence can be used to detect the disease, Keio University said.
By further analyzing the substances, the test detected 99 percent of pancreatic cancer cases, 95 percent of breast cancer, and 80 percent of oral cancer cases among those taking part, it said. The cancer test using the technology would take half a day at the longest, the researchers said.
Source: Bloomberg
