Gut health startup Viome gets breakthrough device designatio

Gut health startup Viome gets breakthrough device designation for mRNA analysis tool


Courtesy of Viome
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.

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