In-home saliva test detects cancer with more than 90% accuracy

[Dec. 28, 2023: JJ Shavit, The Brighter Side of News]

An AI-based home screening test to detect oral and throat cancers from saliva samples is now available in the United States with the hope of transforming oral and throat cancer detection.

Based on a technology approved by the US Food and Drug Administration (FDA) as a "breakthrough device," the saliva test can detect early symptoms of oral and throat cancer with more than 90 percent accuracy.

Due to a lack of effective diagnostic tools, these cancers often go undiagnosed until they have reached an advanced stage, resulting in low survival rates.

In a previous study, Maria Soledad Sosa from the Icahn School of Medicine at Mount Sinai and Julio A. Aguirre-Ghiso, now at Albert Einstein College of Medicine, discovered that the ability of cancer cells to remain dormant is controlled by a protein called NR2F1.

This receptor protein can enter the cell nucleus and turn numerous genes on or off to activate a program that prevents the cancer cells from proliferating. NR2F1 levels are usually low in primary tumors but are elevated in dormant disseminated cancer cells. Levels of the NR2F1 protein then decline once more when cancer cells start proliferating again and form recurrent or metastatic tumors.

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“We therefore thought that activating NR2F1 using a small molecule could be an attractive clinical strategy to induce cancer cell dormancy and prevent recurrence and metastasis,” Aguirre-Ghiso explains.

In the new JEM study, Sosa and Aguirre-Ghiso’s teams used a computer-based screening approach to identify a drug, named C26, that activates NR2F1. The researchers found that treating patient-derived HNSCC cells with C26 boosted the levels of NR2F1 and arrested cell proliferation.

CancerDetect™, produced by Viome Life Sciences, brings unprecedented accuracy to early cancer detection and prevention as the only oral and throat cancer test to offer detection with 95% specificity and 90% sensitivity. Oral and throat cancer is notoriously difficult to detect. Until now, it can often go undiagnosed until it has reached an advanced stage due to a lack of effective diagnostics tools, leading to low survival rates.

Only 28% of patients receive an early diagnosis, and those receiving a late diagnosis face a prolonged battle with oral cancer. (National Library of Medicine). Early detection directly increases the 5-year survival rate for oral cancer patients, from 50% to 84%. With CancerDetect™, Viome has developed a much-needed aid to detect early-stage cancer, leading to more successful treatment outcomes when confirmed with a biopsy.

"Despite all the innovations across the health landscape, oral and throat cancer has remained life-threatening diseases with few options for early detection," said Naveen Jain, Founder and CEO of Viome Life Sciences.

"As an industry leader on a mission to identify and address the roots of chronic disease, we have been working for years to bring to market clinically-backed diagnostics solutions for cancer detection and other life-threatening and debilitating diseases. With the launch of CancerDetect™ for Oral and Throat Cancer, we have achieved this goal and plan to follow this in rapid succession with detection tools for additional life-threatening chronic diseases and cancers.", he continued.

In order to develop a more accurate diagnostic tool for cancer patients, researchers at Viome began studying how the microbiome changed, a collection of all microbes that naturally exist on our bodies and within us, as well as their genes. As a result of earlier research, people with oral or throat cancers have a different oral flora to those without cancer.

Guruduth Bavanar, head of Discovery, AI & Engineering at Viome explained, “We collected saliva samples from people who were 50 years or older, or adults who had a history of tobacco use – both risk factors for oral and throat cancers. From each sample, we extracted genetic material from bacteria, fungi, and skin cells."

In order to train a machine-learning model, the scientists used genetic data from 945 samples, 80 of which came from people with oral cancer and 12 from people with throat cancer.

"A major advantage of machine learning is that the more data we collect, the more accurate the tool becomes," Bavanar told reporters.

88 specific changes in gene expression were identified in people with oral and throat cancer, as well as 182 unique genetic features in their bacteria.

The researchers then tested their model with the remaining 230 study samples, 82 of which came from people with cancer.

Tests correctly identified 90% of samples from people with cancer and 95% of samples from people without cancer, indicating very low false negative or false positive rates.

"With CancerDetect, Viome has developed a much-needed aid to detect early-stage cancer, leading to more successful treatment outcomes when confirmed with a biopsy," Bavanar added.

People at high risk for oral or throat cancer can now buy the test online after filling out a questionnaire with Viome and get results within two weeks.

"A telehealth provider actually reviews the information provided by the customer before ordering the test. Licensed healthcare providers will contact the customer if there is a positive result and the customer can also contact a Viome telehealth partner to ask any questions they may have about the test," explained Banavar.

According to the company, it will continue to seek FDA approval, which would allow the test to be covered by health insurance providers.

"Despite all the innovations across the health landscape, oral and throat cancer has remained life-threatening diseases with few options for early detection," said Naveen Jain, founder and CEO of Viome Life Sciences.

"As an industry leader on a mission to identify and address the roots of chronic disease, we have been working for years to bring to market clinically-backed diagnostics solutions for cancer detection and other life-threatening and debilitating diseases".

"With the launch of CancerDetect for Oral and Throat Cancer, we have achieved this goal and plan to follow this in rapid succession with detection tools for additional life-threatening chronic diseases and cancers".

Note: Materials provided above by The Brighter Side of News. Content may be edited for style and length.

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