Viome scores FDA breakthrough label for cancer-screening, microbiome-sequencing AI platform

green bacteria
Viome’s technology uses machine learning AI and mRNA analysis to screen the microbiome for the early detection of oral and throat cancer. (Gerd Altmann)

The secret to enabling early cancer detection could be hidden in the microbiome, and, now, gut-testing startup Viome has the backing of the FDA to prove it.

Viome was initially launched as a direct-to-consumer service that used an artificial intelligence-powered platform to sequence the RNA in an individual’s stool sample to produce insights into their overall health and provide accompanying diet and lifestyle recommendations. More recently, however, the startup has set its sights on using the technology to screen for cancer.

In a study published last August, Viome researchers used the platform to analyze saliva samples from oral cancer patients and discovered biomarkers in the resulting analysis that were directly linked to cancer signatures.

The diagnostic was able to spot early signs of oral cancer with a sensitivity of about 83%—and over 93% for stage 1 cancers—and a specificity of nearly 98%.

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As a result of that and other ongoing research, Viome’s saliva test has received the FDA’s breakthrough device designation for use in early screening for oral squamous cell carcinoma and oropharyngeal cancer, both of which are typically only diagnosed in a manual examination and are therefore often overlooked until their later stages.

“Today’s standard of care to detect oral and throat cancer is severely outdated.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

“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,” Jain said.

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Alongside accelerating the development of its early diagnostic for oral cancer, Viome will also continue its research into the links between microbiome sequencing data and other diseases.

The company said it has already identified more than 30 precision biomarkers associated with cancers, metabolic diseases, autoimmune diseases, neurodegenerative diseases and mental health conditions. Viome will pursue FDA breakthrough designations for each of these, with a goal of providing a whole host of diagnostic tests to detect chronic diseases as early as possible, when they’re still most treatable.

Beginning in July, that research will be led by Emmanuel Hanon, a 20-year veteran of GlaxoSmithKline who left his post as chief of vaccines research to join Viome as global head of R&D earlier this year. Hanon will oversee the Viome science team’s efforts to identify host/microbial interactions in the company’s database of metatranscriptome sequencing data and use that information to develop therapeutic drugs and vaccines.