Validity of Viome's Oral/throat Cancer Test

Validity of Viome's Oral/throat Cancer Test Among Patients with a Suspicion of Cancer

A total of at least 1,000 participants with suspicion of cancer including at least 107 subjects who will be diagnosed with OSCC or OPSCC will be enrolled from either primary or secondary care centers in the U.S. Clinicians will use Viome collection kits to collect saliva samples from eligible patients.

This is a prospective, multi-center study. Subjects with OSCC or OPSCC will be enrolled from four primary and secondary care centers in the U.S. Study samples will be collected by the clinicians at the study sites using Viome saliva sample collection kits. Patients will continue with their current health plan and confirm diagnosis following the standard of care of surgical biopsy with histology if needed. If a biopsy is performed, the result of the biopsy will be compared with the result of the Viome kit. If no biopsy is performed, the Viome test result will be compared with the physician's assessment based on clinical judgment. Patients with a positive result from histology will not receive the results of the Viome kit, and it will not play any part in the clinical management of the patients.

Inclusion Criteria:

• Signed and dated informed consent prior to any study-specific procedures are performed
• Willing and able to follow the study instructions, as described in the recruitment letter
• Adults (18 years old or older)
• Suspicion of OSCC or OPSCC on clinical presentation by a clinician

Exclusion Criteria:

• Pregnancy
• Use of fertility enhancing medications