The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the early detection of oral and throat cancer through their proprietary mRNA technology in combination with Viome’s next-gen AI platform. The first-of-its-kind tool screens saliva liquid biopsy for the presence of Oropharyngeal Cancer (OPC) and Oral Squamous Cell Carcinoma (OSCC), using unique mRNA analysis technology and machine learning techniques. Naveen Jain, CEO and Founder of Viome, stated, “Today’s standard of care to detect oral and throat cancer is severely outdated.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.”

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