Tim Tai, Senior Photographer

SalivaDirect, Inc. — a spinoff nonprofit organization from the School of Public Health — received a new $3.2 million grant from the National Institutes of Health to increase the accessibility of their saliva-based diagnostic tests. The organization won the RADx Tech Award, which promotes the acceleration, development and commercialization of COVID-19 testing. 

During the pandemic, SPH researchers Anne Wyllie and Nathan Grubaugh developed the SalivaDirect test, an inexpensive and less invasive method of testing for COVID-19 that uses a patient’s saliva rather than a testing swab. Now, SalivaDirect hopes to develop tests with this saliva-based method for other diseases and to work with domestic and international labs to make the test more accessible. 

“The support that the NIH has provided is going to be monumental to the team,” said Steph Tan, a former assistant research lead at SalivaDirect. “There are so many brilliant ideas that emerge but are halted by insufficient funding, so this will certainly catalyze these efforts, and allow us to invest time into the science instead of trying to procure funding.”

According to Wyllie, the inception of this saliva-based protocol was coincidental. One night in 2020, she set up a Polymerase Chain Reaction, or PCR, test — a lab technique that rapidly amplifies copies of DNA segments — where she put saliva directly into gel wells. Even though only half of the wells successfully reproduced the DNA, the results inspired Wyllie and her team to explore the possibility of saliva-based testing.

“There was massive motivation just to help in any way possible and to increase access to affordable testing,” Wyllie told the News. “I have already been working with saliva for well over a decade and I champion its usage. And when we were seeing all the problems with nasopharyngeal swabs very early on in the pandemic response, I sort of wondered whether saliva could help us overcome those.”

After conducting research in 2020 and launching a final protocol in 2021, Wyllie and her team worked with the U.S. Food and Drug Administration, or FDA, to help grant it Emergency Use Authorization, or EUA. This made the test available in labs that meet governmental regulations. In these designated labs, SalivaDirect provided their protocol for doing saliva-based COVID-19 testing.

Even though COVID-19 cases have decreased, researchers at SalivaDirect are excited to expand the organization’s scope to include more infectious diseases. Tan noted that she is especially interested to see if saliva can help detect monkeypox. 

“We’re currently working on projects developing assays for a whole panel of respiratory viruses, as well as herpes viruses,” Claire Laxton, a postdoctoral associate at the School of Public Health and a member of the SalivaDirect team, said in an email to the News. “We’re also examining the potential for saliva in, for example, screening for diabetes, and mild traumatic brain injury.”

The SalivaDirect team pulled together evidence that saliva can be used not only to detect respiratory viruses and bacteria — which get washed into saliva while someone is infected — but also to help study people’s immunity and other disease states. Saliva contains antibodies and other analytes that can offer clues about someone’s health.

Wyllie also wants to develop tests that detect pathogens like the flu and RSV to replace traditional diagnostics, which are usually much more expensive and difficult to produce. Ultimately, Wyllie believes that SalivaDirect testing is useful in settings with few resources, as it is relatively easy to collect saliva without complex collection devices.

Wyllie and her team hope to increase SalivaDirect’s outreach in the upcoming months. Already, the nonprofit  has worked with over 200 labs across the country and they hope to expand even further. 

Each SalivaDirect test costs between $1 and $4.