FDA Names AI Oral Cancer Detection Technology a Breakthrough Device

Dentistry Today


The Food and Drug Administration (FDA) has designated Viome’s proprietary mRNA analysis technology, combined with its next generation artificial intelligence (AI) platform, a Breakthrough Device for the early detection of oral and throat cancer.

The technology analyzes saliva samples for the presence of oral squamous cell carcinoma and oropharyngeal cancer, using unique mRNA analysis technology and machine learning techniques to discover the interactions between microbial activities and human gene progression in these cancers’ progression, Viome said.

Viome has developed more than 30 precision biomarkers for the early detection of cancers, metabolic diseases, autoimmune diseases, neurogenerative diseases, and mental health, the company said. It plans to take each biomarker to the FDA for similar breakthrough device approval and quickly bring them to market.

These efforts are a culmination of Viome’s goal to enable anyone to easily detect chronic diseases early when they can still be reversed with precision nutrition or medicine, the company said.

“Today’s standard of care to detect oral and throat cancer is severely outdated. Everyone relies on a primary care clinician to examine their mouths and look for lesions,” said Naveen Jain, CEO and founder of Viome.

“This subjective and qualitative approach is a key reason why oral and throat cancer are detected at stage three or four, when many people cannot receive lifesaving treatments,” said Jain.

“At Viome, we believe in the power of technology to help everyone stay healthier, do more, and live longer. This FDA approval of our technology and approach for early diagnosis of diseases when they are still treatable further cements our mission,” said Jain.

The approval validates the mRNA analysis technology and AI platform that powers Viome’s at-home Health Intelligence Test, which offers consumers deeper health insights about their own gut microbiome health, cellular health, immune system health, stress response, and biological aging, the company said.

The AI platform analyzes an individual’s unique microbial and human gene expressions to provide them with personalized food recommendations and tailor-made, precision supplements designed to address the root cause of low-grade inflammation and improve these health metrics over time, Viome said.

The technology is based on the work of Chamindie Punyadeera, an associate professor at the Queensland University of Technology (QUT) who has spent a decade researching saliva as an optimum diagnostic liquid for the early detection of oral and throat cancer.

Punyadeera began this research after her young brother-in-law passed away within six months of being diagnosed with oral cancer.

Punyadeera’s systematic collection of saliva samples from oral and throat cancer patients, establishment of saliva collection and optimization protocols, identification of a key unmet need, and work with clinicians provided the foundations for the commercialization of the technology.

“This test could save many lives because until now, early stage oral cancer has been hard to detect because effective diagnostic tools have not been available,” Punyadeera said. “This has led to late diagnosis, poor prognosis, and low survival rates.”

The risk of oral cancer increases with age and increases more rapidly after the age of 50, Punyadeera said.

Punyadeera’s latest study, “The Salivary Metatranscriptome as an Accurate Diagnostic Indicator of Oral Cancer,” has been published by Genomic Medicine.

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