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Viome gets FDA breakthrough device designation for its cancer screening tool

May 13, 2021

The preventive health industry continues to see major breakthroughs, so much so that it’s sometimes tough to keep track of all major developments transforming the space. But this particular breakthrough stands out for its truly revolutionary potential. Viome, the US-based maker of at-home test kits for gut, immune, and cell health, just received FDA breakthrough device designation for its mRNA analysis tool for early detection of oral and throat cancer. Just like its competitors, Viome began its journey with test kits analyzing gene expression to recommend personalized meal plans for improved health. By tweaking the same technology. Viome can now search for throat and oral cancer cells in saliva, thus detecting and tracking the progression of these cancers. Viome’s innovation tackles the clinic’s outdated screening process, the subjective nature of which leads to a higher chance of late detection that often prevents life-saving treatment. With up to 10,000 yearly fatalities from oral and throat cancer in the US alone, Viome’s early screening tool may save countless lives.

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