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Utah company awaits state, federal approval for COVID-19 saliva test

Posted at 6:35 PM, Aug 18, 2020
and last updated 2020-08-18 20:47:00-04

SALT LAKE CITY — The Food and Drug Administration authorized the first saliva COVID-19 test in May which involved a Utah based company. Since then, the FDA has authorized four more saliva-based testing methods, including the Yale School of Public Health’s SalivaDirect COVID-19 diagnostic test.

In Utah, saliva testing has been going on during the pandemic, but it’s not supported by the state's department of health.

“We’re tangentially aware of a number of outfits that are doing saliva testing in Utah. It’s certainly here,” said Utah Department of Health spokesman Tom Hudachko. “We currently at the state lab are not processing any saliva tests, but we do see saliva testing as playing a significant role as we move forward.”

It’s recognized by UDOH that saliva testing is less invasive on patients than the PCR nasal swab and is typically faster to see results. Additionally, the University of Utah along with ARUB Laboratories have been conducting studies on other specimen types pertaining to COVID-19 testing.

“It’s quite often that people will get their results on the same day that they submit their sample,” said Lisa Justesen, Vice President of Regulatory at Soft Cell Laboratories in St. George. “There always has to be a physician between the laboratory and the patient, and then all results are given back to those physicians and all results — positive and negative results — are reported to the state health department on a daily basis.”

Justesen says Soft Cell intended to open as a chronic disease testing facility before COVID-19 altered their plans. Now they offer saliva testing for those with a doctor’s recommendation.

“As long as we’ve got a doctors referral, we can process the sample,” said Frank Spangler, Technical Supervisor at Soft Cell Laboratories. “We get them (patients) from Oregon, Washington, Texas, New York, basically anywhere in the nation.”

Soft Cell Laboratories told FOX 13 they submitted for an emergency use authorization from the FDA but have yet to receive a response. It is legal to administer and process tests without the authorization.

“Because we’re using Thermo Fisher’s assay that has the emergency use authorization — it looks for three targets on the RNA of the virus — and because we’re looking for three different targets and at least two targets have to come up, the test by itself confirms that the virus is there,” said Justesen.

As for the future of saliva testing in Utah, the state’s department of health recognizes the enticing factors of this specific diagnostic test.

“We’re certainly looking and working with partnersthat are testing throughout the state to get as many tests and as many different options in the state as possible,” said Hudachko. “It’s not uncommon for a new test to come online and for it to take a little bit longer to get to market just because you’ve got to go through the process of getting emergency use authorization.”