Frequently Asked Questions

Most oral cancer is discovered late resulting in just a 60% survival rate at 5 years. When caught, late stage treatment is disfiguring and incredibly expensive. Even with routine visual exams, subtle dysplastic lesions are often mistaken for benign conditions or ignored until they become malignant.

OraLiva is a reimbursable, accurate and actionable test to support clinical decisions. Our simple brush test takes less than a minute to collect and helps the provider remove the uncertainty about whether to refer a patient or not to a specialist.

No. Most oral cancers are diagnosed too late despite visual exams. Even oral pathologists disagree about 70%, of the time on what they diagnose as mild oral dysplasia. OraLiva' test helps dental providers triage lesions to catch oral disease earlier, improving patient outcomes and reducing unnecessary biopsies.

Yes! Many dental plans cover the collection under CDT D7288 although D7287 may be used for some plans. Coverage varies by plan so please confirm with the patient dental plan.

After receiving the sample OraLiva will bill the patient’s medical insurance for the analysis.

OraLiva’s test is built on cytology enhanced by advanced imaging and AI-driven diagnostic models. Using a soft-bristle brush, the test collects a transepithelial cell sample that includes surface and basal layers where dysplasia typically arises. The sample is processed in a CLIA-certified laboratory and analyzed with proprietary algorithms that evaluate nuclear morphology, biomarker expression, and cellular phenotype frequencies. Results are compared against the largest oral cytomics databases ever assembled, which allows OraLiva to generate a reproducible risk index for each lesion.

Yes. OraLiva’s technology and diagnostic models have been documented in multiple peer-reviewed publications in oncology and dental research journals. These studies have undergone independent review and replication, ensuring that the science is transparent and credible. A full list of publications is available on OraLiva’s website.

If a patient presents a lesion in the mouth, answering yes to any of the following questions should immediately test:

• Is the lesion larger than a 10mm?
• Is the lesion red or red and white in color?
• Is the patient a smoker?
• Is the patient over 60?

Any dental or medical provider. Hygienists should make sure to coordinate care with the dentist as the dentist will ultimately order the test but they are able to collect the samples with a few turns of the brush.

See resources page for instructions on collecting sample.

After identifying a lesion, discuss testing with the patient, collect consent, and use the kit’s simple instructions to obtain a sample. The sample is mailed to our lab with prepaid shipping, and results typically returned within 7 days.

The brush is soft and feels like firm toothbrushing. Most patients tolerate it well, and topical anesthetic may be used for sensitive lesions without affecting the test results.

OraLiva’s test report includes the Oral Cancer Numerical Index (OCNI). The OCNI is like a thermometer for cancer. Results from primary care of above 36.5 suggest an immediate referral for follow up care may be necessary.

No OraLiva has not yet received FDA clearance. OraLiva’s test is currently approved for use as a CLIA Certified Laboratory Developed Test (LDT). The test has been validated through large international prospective studies as documented in numerous peer reviewed publications (insert link to our publications page). However, OraLiva is committed to moving toward the development and release of the first quantitative AI linked cytology tool for use chairside. These powerful capabilities will be available immediately through the ship in service.

The test is 97% accurate, 94% sensitive and 92% specific in detecting cancer at the earliest stage (dysplasia). The high sensitivity means more patients are caught as early as possible. The high specificity means fewer patients are referred to specialists unnecessarily.

Failure to diagnose oral cancer is the leading cause of dental malpractice claims. OraLiva provides objective support for referral decisions, reducing risk while improving patient care. Documented use of adjunctive tools like OraLiva strengthens your clinical record by showing you took reasonable steps to assess a suspicious lesion. Because OraLiva is an adjunctive aid, not a replacement for biopsy or your clinical judgment, it does not create additional liability. Instead, it provides defensible support for your decision to monitor or refer.

Dentists currently report referring an average of ~9.5 patients per year for suspicious oral lesions representing less than 1% of those they see. Yet, studies show that more than 10% of the adult population has an oral mucosal lesion.

This gap means too many cases are detected at a late stage, when outcomes are far worse. To change that, dentists need a simple way to evaluate more lesions earlier. With OraLiva’s accurate, non-invasive test, widespread screening and earlier intervention are finally within reach.

Light-based devices can highlight areas of abnormal tissue but do not demonstrate sufficient diagnostic test accuracy to support their routine use as triage tool during the evaluation of lesions in the oral cavity. OraLiva goes deeper by analyzing the cells themselves and providing a numerical risk score quantifying the risk. This makes it more specific and actionable when determining whether to monitor or refer patients. However, light-based findings and OraLiva testing can also be used together to enhance detection and triage.