FDA Grants Breakthrough Device Designation for a Viome Device for the Proposed Intended Use

FDA has granted breakthrough device designation to a Viome device with the following proposed intended use:

The OralViome Cancer Testing System is intended for the qualitative detection of molecular features (human genes, microbial species and functions) associated with Oral Squamous Cell Carcinoma (OSCC) or OroPharyngeal Cancer (OPC) in saliva samples from adults either, (i) 50 years or older; OR (ii) who have a history of tobacco use. A positive result from the OralViome Cancer Testing System may indicate the presence of OSCC or OPC. The device is intended as a screening tool to aid clinicians in identifying patients with suspected OSCC or OPC who may benefit from follow-up diagnosis and treatment. The device is not intended for diagnosis.

This device has not been cleared or approved by the FDA. Please refer to the FDA guidance document entitled "Breakthrough Devices Program", for more information regarding the program, available at https://www.fda.gov/media/108135/download.