FDA authorizes Covid-19 saliva test for emergency use

The US Food and Drug Administration has authorized a saliva test for “emergency use” for diagnosing Covid-19. Rutgers University, where the test was developed in collaboration with other groups, announced the FDA authorization on Tuesday after formally receiving it over the weekend.

Using saliva to diagnose novel coronavirus infections could expand testing capacities across the United States. So far testing for Covid-19 has usually involved nose or throat swabs.

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“It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections,” Andrew Brooks, chief operating officer and director of technology development at the university’s RUCDR Infinite Biologics lab, said in a news release on Tuesday.

“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,” Brooks said. “All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”

According to Rutgers University’s news release, this is the first such saliva test to receive emergency use authorization from the FDA. Brooks, a professor at the university, called the impact of the authorization “significant.”

Rutgers University has partnered with the RWJBarnabas Health network and Middlesex County in New Jersey to make the saliva tests available beginning on Wednesday to residents through a drive-thru testing facility in Edison, New Jersey.

A health worker handles a coronavirus swab test at a drive-thru testing center for COVID-19 at Lehman College on March 28, 2020 in the Bronx, New York City. The center, opened March 23 at Lehman College, can test up to 500 people per day for COVID-19. (Photo by John Moore/Getty Images)

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US Food and Drug Administration Commissioner Dr. Stephen Hahn, emphasized on “Fox & Friends” Tuesday morning that the new saliva-based Covid-19 test that received an emergency use authorization is not a test that can be done at home.

“This 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,” Hahn said.

“It highlights the great innovation that we’ve seen around the country in response to the outbreak,” he aid. “You can use saliva rather than the swab in the nose. It’s more comfortable for the patient. Obviously, it can be repeated multiple times and it’s actually safer for the health care provider in terms of collection.”

This is a picture of CDC's laboratory test kit for the 2019 novel coronavirus (2019-nCoV). CDC is shipping the test kits to laboratories CDC has designated as qualified, including U.S. state and local public health laboratories, Department of Defense (DOD) laboratories and select international laboratories. The test kits are bolstering global laboratory capacity for detecting 2019-nCov.

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One company, Vault Health, is selling the Rutgers saliva test kit for $150 and responded in an email to CNN that the saliva for the test could be collected at home during a telehealth doctor’s appointment. According to the company, that would meet the requirement of the test being performed with a provider

“It is no different than if a patient was standing in front of a medical professional in a physical office,” Vault Health Founder and CEO Jason Feldman said in the email.

“In the uncertain times we find ourselves, with social distancing showing real results of flattening the curve, plus the scarcity of PPE, Vault believes this is an effective method to maintain the safety of medical professionals and the patients to whom they provide care,” he said in part.

Yet there still appears to be a regulatory gray area in this evolving landscape of testing.

In a written statement emailed to CNN on Sunday, FDA spokesperson Stephanie Caccomo said that “at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19.”

She added, “The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”

Across the United States, which has faced a shortage of tests, several other laboratories have been working on developing saliva tests and other types of diagnostic testing for Covid-19.

So far, during the coronavirus pandemic, the FDA has worked with more than 300 test developers who have said they plan to submit emergency use authorization requests to the agency for their diagnostic tests, the agency announced on Monday.

According to the FDA, 34 emergency use authorizations have been issued for diagnostic tests to date.

CNN’s Arman Azad contributed to this report.