" class="no-js "lang="en-US"> Viome Receives FDA Approval for its Unique mRNA Technology and AI Platform to Detect Cancers - Medtech Alert
Saturday, December 02, 2023

Viome Receives FDA Approval for its Unique mRNA Technology and AI Platform to Detect Cancers

Viome, a mission-driven bioscience company focused on helping individuals improve their health, today announced its proprietary mRNA analysis technology combined with its next-generation AI platform has been designated a Breakthrough Device by The Food and Drug Administration (FDA) for early detection oforal cancer and throat cancer.

Viome’s proprietary technology and AI platform is a first-of-its-kind screening tool for oral cancer and throat cancer, two life-threatening diseases that are traditionally diagnosed manually by a primary care clinician by visual or tactile senses in a subjective way, often going undiscovered. Making saliva the new liquid biopsy, Viome analyzes samples for the presence of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Cancer (OPC). Viome has employed unique mRNA analysis technology and breakthrough machine learning techniques to accurately discover the interactions between microbial activities and human gene expression in the progression of these cancers.

As a part of its mission to prevent and reverse chronic diseases, Viome has already developed more than 30 precision biomarkers for the early detection of cancers, metabolic diseases, autoimmune diseases, neurodegenerative diseases, and mental health. The company plans to take each of these biomarkers 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 disease early on when they can still be reversed with precision nutrition or medicine.

“Today’s standard of care to detect oral and throat cancer is severely outdated.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

This FDA approval validates Viome’s mRNA analysis technology and state of the art AI platform that powers Viome’s at-home Health Intelligence Test designed to offer consumers deeper health insights about their own gut microbiome health, cellular health, immune system health, stress response, and even biological aging. Viome’s 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.

This news comes on the heels of Viome hiring Dr. Emmanuel Hanon, the former Global Head of Vaccine Research and Development at GlaxoSmithKline (GSK). Through this new FDA approval and Dr. Hanon’s hiring, Viome is well-positioned to advance its precision diagnostic and therapeutics platform intended to prevent, diagnose and treat chronic diseases and cancers leading to healthy aging. To learn more, visit www.viome.com.

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