Viome's mRNA technology and AI platform powers its at-home Health Intelligence Test

FDA device

The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Bioscience company Viome has secured breakthrough device designation from the US FDA for its advanced mRNA analysis technology combined with its advanced artificial intelligence (AI) platform to detect oral and throat cancers.

The company’s advanced mRNA technology and AI platform is claimed to be the first-of-its-kind screening tool for the two life-threatening diseases.

Traditionally, the diseases are diagnosed manually by a primary care clinician by visual or tactile senses in a subjective way.

By using saliva as the new liquid biopsy, Viome carries out the analysis of samples to identify the presence of oral squamous cell carcinoma (OSCC) and oropharyngeal cancer (OPC).

To precisely detect the interactions between microbial activities and human gene expression in the progression of these cancers, Viome has used advanced mRNA analysis technology and breakthrough machine learning techniques.

Viome founder and CEO Naveen Jain said: “Today’s standard of care to detect oral and throat cancer is severely outdated.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.

“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 life-saving treatments.

“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.”

The FDA approval validates Viome’s mRNA analysis technology and AI platform, which powers the firm’s at-home Health Intelligence Test.

Viome’s Health Intelligence Test is designed to offer health insights to consumers about their own gut microbiome health, cellular health, immune system health, stress response, and even biological aging.

Viome’s AI platform has the potential to analyse an individual’s unique microbial and human gene expressions to deliver them with personalised food recommendations and relevant supplements.

The company claims to have already developed over 30 precision biomarkers for the early detection of cancers, metabolic diseases, autoimmune diseases, neurodegenerative diseases, and mental health.