Victoria Frankel

Viome Receives FDA Breakthrough Device Designation for its Unique mRNA Technology and AI Platform to Detect Cancers

Apr 30, 2021

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FDA Breakthrough Designation Validates Viome’s Proprietary mRNA Analyzing Technology and State of the Art AI Platform to Screen for Oral Cancer and Throat Cancer


The human body talks. It speaks in frequencies and through chemistry, and if you know how to listen - it can tell you remarkable things. But just as remarkable, it can also communicate when things are going awry. 

Inside each of us are complex mechanisms that signal to cells and to systems that something is wrong. These signals are often sent packaged in small molecules that interact with different types of cells - from our blood cells to our brain cells, or to our gut cells and beyond. Scientists refer to many of these small molecules as ‘biological markers’ - or biomarkers - which is a broad name for any biological compound that is connected to a specific health outcome or disease. Now Viome has created a new early screening tool that has received FDA Breakthrough Device designation to diagnose the earliest stage of Oral and Throat Cancer.

About The Food and Drug Administration’s Breakthrough Device Approval Process:

The FDA considers a technology worthy of breakthrough designation when it represents unparalleled innovation with no cleared alternatives, has the potential to be a more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions, and has the opportunity to benefit the lives of many patients. 


A Breakthrough in Diagnostics

When Viome set out to map the gut microbiome and examine the unique patterns and trends of microbes in our gut, we saw the potential for so much more. Our goals included analyzing them and comparing this data against many health conditions. And in our various studies, we have utilized the information from key biomarkers to determine how effective our recommendations were at improving health.

This has led us to one of our greatest endeavors: using our proprietary technology and AI platform to aid in screening for other conditions, like cancer. Focusing first on Oral and Throat Cancer, two life-threatening diseases typically diagnosed by a physical examination from primary care clinicians, we sought to reduce the number of cases that go undetected for too long. The truth is all too common: many individuals find out they may have cancer long after it has manifested. But now, with a saliva test, Viome is capable of analyzing samples for the presence of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Cancer (OPC).

Our ability to examine mRNA sequences (determining the level of expression from specific genes) and compare them against a database of biomarkers (not to mention utilizing our incredible machine learning techniques) makes determining your risk of disease faster than ever. Faster answers can mean better outcomes and get you the information you need to more rapidly seek clinical help.

And this is just one example of how Viome is working to prevent and reverse chronic diseases. So far, we’ve developed more than 30 precision biomarkers for the early detection of cancers, metabolic diseases, autoimmune diseases, neurodegenerative diseases, and mental health conditions. 

To do this, we looked no further than tapping into the same technology we employ to provide each Viome customer with their own individual assessment of their gut and cellular health. When you send in your sample through our Gut Intelligence Test or Health Intelligence Test, we examine the mRNA (or genetic expression) of your personal and microbial cells. This data helps provide a comprehensive snapshot of your health and gets integrated into our AI technology algorithm - with a little help from our Clinical Nutrition Team - to create the dietary and supplemental recommendations found on your app. It’s this same technology and expertise we’ve used to generate our new Oral and Throat Cancer diagnostics, so you can imagine there is still a ton of information that gets captured and sent back into the algorithm with every test. Just like us, our algorithm is constantly evolving and learning and making smarter and smarter decisions.


Up and Onward with Disease Research

In line with our mission to eradicate chronic diseases, we remain optimistic by the untapped potential of the gut microbiome. We have seen how connected the microbes that call us home are too many regions of the body. And how connected they are to each other!

Now, we’re employing the help of many other specialists to continue to develop and expand our knowledge in these various regions. For example, Viome has welcomed Dr. Emmanuel Hanon to our team. Dr. Hannon was the former Global Head of Vaccine Research and Development at GlaxoSmithKline (GSK) and brings his impressive research experience to our team. 

Together, we will continue to create innovative new methods for diagnosis and treatment for the many conditions that plague the world. And by using the impressive power behind our dietary choices, we can continue to break down the barriers of disease and treat our food with respect as the most potent form of preventative medicine.








The information on the Viome website is provided for informational purposes only and with the understanding that Viome is not engaged in rendering medical advice or recommendations. Viome provides this educational information to share the exciting developments being reported in the scientific literature about the human microbiome and your health. Viome products are not intended to diagnose, treat, or prevent any disease.







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Viome Receives FDA Breakthrough Device Designation for its Unique mRNA Technology and AI Platform to Detect Cancers

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