First Coronavirus Saliva Testing Site Opens In U.S. After Emergency FDA Authorization
The first U.S. coronavirus saliva testing site opens Wednesday in New Jersey after the Food and Drug Administration granted emergency authorization for the method, which healthcare experts say is quicker, more scalable and safer to administer as the virus continues to spread across the country.
The saliva testing method was developed by a Rutgers University lab, NBC New York reported, and the FDA granted emergency authorization for it on Friday.
President Trump hailed the saliva test during his Tuesday press briefing: “I call it innovation under pressure.”
Patients take the test by spitting into a saliva collection device, which saves swabs used for nasal tests and decreases the amount of contact between healthcare workers and patients.
A proprietary solution detects the virus in the saliva, according to NBC, and the turnaround for results is 24 to 48 hours.
Thousands of saliva samples can be processed daily, said Stephen Fanning, president of Utah Spectrum Solutions, a biotech firm that worked on the saliva test.
It remains unclear if enough of the virus will be present in saliva to produce consistently reliable results, ABC News reported, but a Rutgers review of a small sample size submitted to the FDA showed the saliva test was just as reliable as nasal swab testing.
“We can preserve precious personal protective equipment for use in patient care instead of testing. We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections,” said Andrew Brooks, a senior official at the Rutgers lab, in a press release. “All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”
The saliva test developed by Rutgers is available in New Jersey’s RWJBarnabas healthcare system and a number of hospitals. The drive-thru testing site is located in Edison, New Jersey, at a local DMV inspection bay. As of Wednesday morning, Fanning saidhis firm could supply one million saliva tests per month, and could scale up to 5 million in the near future.
At least two other companies, Vault Health and BioIQ, have worked on producing saliva tests. Vault, a men’s health company that pivoted to making a saliva test, is working with Rutgers but also produced an at-home version of the test. FDA commissioner Stephen Hahn said in a Tuesday Fox appearancethat the test the agency authorized is “is not an at-home test. This still has to be performed with a provider, but it does provide great advantages moving forward and expands the opportunities for testing.”