Viome, maker of at-home test kits for gut, immune and cellular health, has received FDA breakthrough device designation for its mRNA analysis technology and artificial intelligence platform that detect early signs of oral cancer and throat cancer.

The FDA designation validates the technology used in Viome’s at-home Health Intelligence Test that analyzes users’ microbial, human and mitochondrial gene expression to recommend personal nutrition plans.

Viome has adapted that same technology to search for the presence of oral squamous cell carcinoma and oropharyngeal cancer in users’ saliva samples. It examines the interactions between microbial activities and human gene expression to screen and predict the progression of these cancers.

WHY IT MATTERS

An estimated 54,010 new cases of oral cavity or oropharyngeal cancer will be diagnosed in the U.S. this year, according to the American Cancer Society. More than 10,800 deaths from this type of cancer are also expected to occur in 2021.

Despite these statistics, there has been no routine screening test or program for oral and throat cancers up until now, according to the American Cancer Society.

"Today's standard of care to detect oral and throat cancer is severely outdated,” Naveen Jain, the CEO and founder of Viome, said in a statement.

“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.”

Viome says it has developed more than 30 different biomarkers for the early detection of cancers, metabolic diseases, autoimmune diseases, neurodegenerative diseases and mental health conditions that it plans to get validated by the FDA.

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

THE LARGER TREND

While Viome has modified its gut health test for cancer screenings, others have kept their focus on nutrition support.

 ZOE, a newcomer to the space, creates a personalized dietary plan for its users based on the results of their gut health, blood sugar and blood fat at-home tests. The company recently raised $20 million in Series B funding.

DayTwo uses its gut microbiome test to help customers monitor how their food intake is affecting their nutrition. It raised $31 million in Series B financing in 2019.

There’s also Vivante Health, which scored $5.8 million last year for its digital digestive health program that includes an at-home microbiome testing kit, a breath-based food-sensitivity monitor, a 24-7 support line to a gastrointestinal care team and other tools.