> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Breakthrough Designation for Oral Cancer Detector
- URL: https://www.fdaweb.com/breakthrough-designation-for-oral-cancer-detector/
- Published: 2021-05-07T12:00:00.000Z
- Updated: 2026-09-14T16:58:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149277

FDA has granted Viome a breakthrough device designation for its proprietary mRNA analysis technology combined with its next-generation artificial intelligence (AI) platform for use in early detection of oral and throat cancer. The device uses saliva as a “liquid biopsy” to analyze samples for the presence of oral squamous cell carcinoma and oropharyngeal cancer, the company says. Viome uses mRNA machine learning techniques to “accurately discover the interactions between microbial activities and human gene expression in the progression of these cancers,” it says. The device was designed to improve traditional oral/throat cancer detection, which typically relies on a primary care clinician to examine patients’ mouths for lesions, Viome says.