Viome Oral Health Pro™ with CancerDetect®
Secondary care follow-up information if test is DETECTED
The Viome Oral Health Pro™ with CancerDetect is a detection test for salivary biomarkers associated with oral squamous cell carcinoma (OSCC) and/or oropharyngeal squamous cell carcinoma (OPSCC). The test has been validated to detect molecular features that are associated with OSCC and/or OPSCC. The specificity of the test is 95%, and the sensitivity 90% for subjects with OSCC and 90% for subjects with OPSCC1. The underlying cancer biomarker detection test has been granted FDA breakthrough device for accelerated review for the qualitative detection of OSCC and OPSCC. The device is intended as a diagnostic aid for clinicians with suspected OSCC or OPSCC who may benefit from follow-up diagnosis and treatment. The device is not intended for definitive diagnosis.
The information in this document is intended for patients who received a “DETECTED” result from the test, and have been referred to secondary care specialists for follow-up diagnosis and treatment.
A "DETECTED” result means that the CancerDetect test has detected molecular markers associated with OSCC and/or OPSCC in the patient’s saliva, whether or not lesions were visible in a patient’s oral cavity. A primary care provider, such as a dentist or hygienist, should have performed the CancerDetect test after evaluating the patient’s risk factors, and performing a visual & tactile oral examination. If the patient received a “DETECTED” result, the provider would have referred the patient immediately to a secondary care specialist, such as a head and neck oncologist, an oral and maxillofacial surgeon, or an otolaryngologist (ENT specialist).
No identifiable information about you is collected in this assessment and your dentist does not receive any direct compensation. We view this as a major public health initiative and the current data suggests that a few minutes of your time could save your life!
The secondary care specialist will follow the standard of care to confirm if cancer is present, by performing one or more of the following steps whether or not visible lesions were found by the primary care provider:
- A thorough examination of the mouth, throat, and neck
- An oral endoscopy if necessary
- Imaging procedures if necessary, such as computerized tomography (CT) scan, magnetic resonance imaging (MRI), radiography for jaw bones, or positron emission tomography (PET)
- A biopsy if a lesion is found in the oral cavity, or fine-needle aspiration if lump is found in the neck, to obtain a sample of tissue, and proceed with histopathology for definitive diagnosis
It is important to note that in a small number of cases, no lesion may be found in the oral cavity, or lump in the neck. This is due to the specificity of the CancerDetect test being 95%, which means that up to 5% of DETECTED test results may be false positives. In these cases, the patient should consult with their provider and continue testing regularly at the normal recommended visits to their provider.
Additional resources
- American Cancer Society (ACS): https://www.cancer.org/cancer/types/oral-cavity-and-oropharyngeal-cancer.html
- American Society of Clinical Oncology (ASCO) https://www.cancer.net/cancer-types/oral-and-oropharyngeal-cancer/introduction
- Centers for Disease Control and Prevention (CDC) https://www.cdc.gov/cancer/headneck/index.htm