At-home diagnostics startup Viome Life Sciences has launched a new test to help detect oral and throat cancers.
Oral Health Pro with CancerDetect can detect biomarkers associated with oral and throat cancers with a specificity of 95% and sensitivity of 90%, according to clinical validation data recently published by the company. A highly sensitive test means there are few false negatives, while a highly specific test means there are few false positives.
The test is "the most advanced oral and throat cancer screening test available" on the market, per Viome. Patients 50 years or older, or 18 and older who use or have used tobacco products, are eligible for the test.
The vast majority of oral cancers in the U.S. are attributable to tobacco use and alcohol consumption. The average survival rate of oropharynx cancer is 52%, and there is no routine screening test or program for these types of cancers. While the exact survival rate from early detection is hard to pinpoint, it is well established that early detection of cancer saves lives.
“Viome’s holistic and scientific approach to health will transform how people approach oral hygiene and care,” Ed Zuckerberg, Viome’s chief dental officer, said in a press release. “The current standard of oral care is extremely outdated, relying heavily on visual and tactile examinations. Viome is setting a new standard that uncovers the intricate interplay between microbial activities and human gene expression in the development of oral diseases and cancers.”
The new offering relies on Viome’s proprietary RNA sequencing technology and AI to measure gene expression of the oral microbiome and human cells in each patient’s saliva, which are used to identify early biomarkers associated with oral and throat cancers.
The product's underlying test has received an FDA breakthrough device designation for accelerated review, the company said. It is not currently cleared by the FDA. Because the company owns and operates a CLIA-certified lab, the test is sold as a Laboratory Developed Test, which is ordered by a dentist, physician or qualified healthcare provider.
The test is priced at $599. Oral Health Pro is a cloud-based, no-cost software that can be integrated into any practice, according to Viome.
Patients must fill out an eligibility form to access the test, which is reviewed by a provider with Viome partner PWNHealth, a national clinician network. Then, the saliva sample collected at home is sent to Viome's lab. The results are available in a digital report. If cancer is detected, the same PWNHealth provider will call the patient for a review of the results and best next steps.
The company’s broader goal with the test is to change the way dental professionals and consumers think about oral health, highlighting the link between oral health and overall physical health. The biomarkers the test can detect are associated with symptoms like poor gum health, cavities, bad breath and more, many of which are associated with systemic health risks, per Viome.
“Viome’s unique technology can see a lot deeper than other tests since we detect the gene expression activity of a wide range of microbial as well as human cells,” Guru Banavar, Ph.D., Viome’s founding chief technology officer, said in the announcement. “We further quantify the molecular pathways associated with oral health issues by applying machine learning on a very large dataset, trillions of nucleotides derived from tens of thousands of saliva samples. These analyses are translated into a simple report that helps dental professionals and patients understand their oral and systemic health risks.”