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Viome News

Viome Oral and Throat Cancer detection test designated Breakthrough Device for accelerated Review by FDA

FDA approval

BELLEVUE, Wash., May 6, 2021 /PRNewswire/ -- Viome, a mission-driven bioscience company focused on helping individuals improve their health, today announced its Oral and Throat Cancer detection test built on Viome’s metatranscriptomics and AI platform was designated Breakthrough Device for accelerated Review by The Food and Drug Administration (FDA).

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 RNA 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 and request similar breakthrough device designation 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"Today's standard of care to detect oral and throat cancer is severely outdated.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 test powered by our technology and approach for early diagnosis of diseases when they are still treatable further cements our mission."

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

About The Food and Drug Administration’s Breakthrough Device Program:
Viome successfully demonstrated to the FDA that it met the very strict criteria the administration uses to designate a technology as a breakthrough for accelerated review by FDA, including:

  • It provides a more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions;

  • for which no approved or cleared alternatives exist;

  • that offer significant advantages over existing approved or cleared alternatives;

  • the availability of which is in the best interest of patients

About Viome
Viome was founded in 2016 with a mission to make illness optional by predicting and preventing chronic diseases through a deeper understanding of an individual's biology at a molecular level. Viome is the industry's only direct-to-consumer healthcare company that analyzes microbial and human gene expressions (RNA), with technology exclusively licensed from Los Alamos National Lab, to provide individuals with health insights and the nutrition they need.

Today, Viome has become a global healthcare company, developing precision nutrition, precision drugs, and precision vaccines to help people live a disease-free life. Viome has developed a state-of-the art artificial intelligence platform that analyzes the data from the world's largest and richest gene expression database to identify the root causes of chronic diseases and the mechanisms of action to be able to prevent and reverse these diseases.



Viome’s CancerDetect Test is not an FDA-approved or cleared test.