alt=Jasen LeeDRAPER — A Utah company says it has developed a test that may allow virtually anyone to find out whether they have the new coronavirus.
Scientists at Spectrum DNA have repurposed technology initially created to help users trace their ancestral lineage through saliva to now be used to detect COVID-19. Until recently, testing for the coronavirus required individuals to undergo invasive and often painful nasal and throat swabbing to gathering biologic material necessary for examination.
The company said saliva testing is a new development that, when administered under the direction of a qualified medical professional, will allow for self-administered sample collection by individuals who may be in quarantine or self-isolation or for those showing no outward signs of illness.
“We ran a study side by side, taking the swabs — either nasal swabs or throat swabs — and we looked at those versus looking at the saliva test, and it was 100% accurate in predicting if you had the virus or not,” said Stephen Fanning, CEO of Spectrum Solutions, which is headquartered in Draper.
“This is a significant improvement in a couple of ways. Obviously, putting a very long swab in your nose is not easy (and) it’s rather painful, so with ours, there’s less pain,” he said. “No. 2, to do the swab method, you need to have a professional person stand there to insert the swab into the nasal cavity. Obviously, that potentially puts the professional at risk of getting the virus.”
The new method, which involves using a proprietary preservative solution, eliminates the risk to those handling the samples, Fanning said.
“You take the top off (the testing device) and spit into it. You get rid of that and you take the top of the device and you turn it, then it punctures the saliva into the tube,” he explained. “Our proprietary preservative basically does a couple things. First and foremost, it actually kills the coronavirus but it leaves behind what are called the (ribonucleic acid, or RNA) markers.
“By killing the virus, when the person who is in the lab looks to test it, there’s not the issue that they can potentially become infected as a result of opening that up. Then more importantly, the preservative really (maintains) the RNA markers to determine if you in fact have the virus.”
RNA is a nucleic acid that exists in all living cells whose primary function is to behave as a messenger that carries instructions from DNA for controlling the synthesis of proteins. However, in some viruses, RNA conveys genetic information rather than DNA.
The new validation of the saliva testing method came after researchers in New Jersey were able to confirm the reliability of the results during a comprehensive trial.
“We did a clinical study to look whether or not saliva could replace and or be used in place of nasal pharyngeal oral pharyngeal swabs for detecting COVID-19 in both symptomatic and asymptomatic patients,” said Andrew Brooks, chief operating officer of RUCDR Infinite Biologics and professor of Genetics at Rutgers University.
“So the standard of care is to take this really long Q-tip and stick it up your nose down and the back of your throat almost, which is very uncomfortable, in order to swab that area because that’s where the virus likes to live — and it requires a health care professional do it.”
He noted that they were able to demonstrate that saliva actually is more sensitive than the swab and has a higher concentration of virus for those infected.
“Now what that does is make testing more globally available,” Brooks said.
“Now imagine you pull up, you roll down your window, they give you a lot of the collection device, it takes a minute to spit into it. You put the cap on, which releases the preservation solution into the vial,” he said. “You wipe it with a little alcohol pad and you hand it back to the person at the window and you go off on your way. Twenty-four hours later, you get your test results without exposing anybody or without wasting any other (resources).”
The study was conducted last month and immediately submitted to the Food and Drug Administration. For now, the saliva testing method is being used by individual health care providers under an emergency use authorization from the FDA, Brooks explained. Each health care provider must submit an application for their own authorization, he said.
New York and New Jersey have already accepted the new parameters Spectrum has put forth in its application to the FDA, he said. Currently, no laboratories in Utah are authorized for the new testing, but providers anywhere in the country using the Spectrum test device can send their samples to RUCDR Infinite Biologics for results until more providers are added, he said.
Fanning noted that the tests would be in the cost range of approximately $55 and likely be covered by standard health insurance, making it affordable and readily accessible to the vast majority of people. He added that the company will soon be able to produce over 1 million tests per month.
Brooks said one other company is also developing a saliva test, which will help create greater accessibility for more people nationwide.
“Having more testing available for people will get people that are sick and need testing quicker, and will also get us to where we can test people who are asymptomatic that are spreading the virus and not know it,” he said.