Frequently Asked Questions

Why perform OraLiva's test?

Most oral cancer is discovered late resulting in only a 45% 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.

 

Is a visual-tactile exam enough?

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 helps dental providers catch oral disease earlier, improving patient outcomes and reducing unnecessary biopsies.

 

Is OraLiva’s test covered?

Yes! Most dental plans cover the collection under CDT D7288 although D7287 may be used for some plans. OraLiva will bill the patient’s medical insurance for the analysis.

 

How does the OraLiva test work?

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.

 

Are the results validated, published and peer-reviewed?

Yes. OraLiva’s validation studies 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.

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Which patients should I test?

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?

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Who can use the test?

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

 

What’s the workflow?

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.

 

Does the brush hurt?

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.

 

What are the results from the OraLiva test and what are the next steps?

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. 

 

Is the OraLiva test FDA-approved?

OraLiva’s test is currently approved for use as a CLIA Certified Laboratory Developed Test (LDT) but has not yet received FDA clearance. 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.

 

How accurate is the test?

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. 

 

What are the liability implications of using the test?

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.

 

How many patients should I be testing?

In the US, about 10% of adults have an oral lesion at a given time. Further, one in four of these adults has an oral potentially malignant disorder (OPMD) that warrants testing. Putting this into the context of a typical GP dentist which covers about 3000 patient visits each year, there are typically about 300 patient visits with oral lesions and about 75 patients presenting with OPMDs. 

 

Does OraLiva detect dysplasia, leukoplakia and lichen planus?

Yes. All of the above with strong clinical validation as acquired through larger prospective clinical studies. OraLiva’s test is designed to detect cellular features associated with oral dysplasia, and the supporting validated diagnostic models help to distinguish between benign oral lesions like leukoplakia and oral lichen planus from more severe oral lesion disease harboring stronger malignant potential.

 

Some practices use a light to screen for oral cancer. How is the OraLiva different from light-based tests?

Light-based devices can highlight areas of abnormal tissue but do not evaluate cellular changes and don’t provide actionable insights. 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 accuracy.

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*Peer-reviewed publications supporting accuracy reporting:

McRae, McDevitt, Journal of Dental Research, 2021, 100, 479-486.

McRae, McDevitt, Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 2024, 138(1): 88-98.

Abram, McDevitt, Oral Oncology 2016, 92:6-11.

Speight, McDevitt, Oral Surgery Oral Medicine Oral Pathology and Oral Radiology 2015, 120 (4), 474-482.

McRae, McDevitt, Cancer Cytopathology 2020, 128(3): 207-220, Wiley Top Cited Award.