Frequently Asked Questions
Why perform OraLiva's ORAL ONC In-CYT test?
OraLiva provides an objective, accurate and actionable test to support clinical decisions, helping providers triage lesions, expand to new revenue streams, improve referral efficiency, reduce unnecessary biopsies, and catch high-risk oral lesions earlier to save lives.
How does the OraLiva test work?
OraLiva uses a soft cytology brush to collect epithelial cells, which are analyzed using AI-powered cytology. OraLiva’s ORAL ONC In-CYT test delivers accurate and clinically actionable analysis for suspicious oral lesions regarding the risk levels for oral lichenoid conditions, oral epithelial dysplasia and oral cavity cancer.
Who can use the test, and who is it for?
Any dental provider — including general dentists, dental hygienists, periodontists, oral and maxillofacial surgeons (OMS) can use the OraLiva test. ORAL ONC In-CYT is intended for patients who present with unknown or suspicious oral lesions or who are at elevated risk for oral cavity cancer, such as tobacco users or those patients with oral lesions associated with persistent red, white, or mixed red and white patches.
What’s the workflow like for OraLiva in a clinic?
The provider collects a brush biopsy sample from the suspicious lesion, sends the specimen via a prelabeled envelope to OraLiva’s LDT Testing Facility in Durham, NC, and receives an informative test report which categorizes the risk and recommends a course of action.
Does the brush hurt?
The brush used is soft and designed for comfort. Most patients report only mild pressure similar to firmly brushing your teeth. Some patients that present with tended oral lesions may be offered topic anesthetic to help manage the discomfort of these sensitive oral lesions.
What codes should be used for billing, and is the test reimbursable?
Use CDT code D7288 for dental billing. Patient medical insurance is billed for lab processing. In some states and with some dental insurance providers the reimbursement is not guaranteed; prior authorization or patient-pay models may be necessary in these circumstances.
What are the results from the OraLiva test and what are the next steps?
OraLiva’s ORAL ONC In-CYT test results in an Oral Cancer Numerical Index (OCNI) score with associated threshold to recommend patients be monitored or referred to a specialist. The test report includes the actionable recommendation for primary care and the detailed analysis for specialists. With the use of this test the non expert provider is empowered to deliver expert level referral recommendations that will allow for selected high risk patients to seek follow up care including histology analysis of tissue as completed by OMS.
What does a positive OraLiva result mean?
The ORAL ONC In-CYT test identifies cellular changes linked to early-stage oral diseases like dysplasia, CIS, or OSCC. It supports, but does not replace, a definitive diagnosis — follow-up with a biopsy or specialist is recommended for positive results. While general dentists see most patients with suspicious lesions, only 1 in 8 are referred, leading to late-stage diagnoses. This test aims to shift detection earlier and support routine surveillance of high-risk patients.
Is the OraLiva test FDA-approved?
No, the OraLiva test is currently for use as a CLIA Certified Laboratory Developed Test (LDT) and has not yet received FDA clearance. The test has been validated through large international prospective studies as documented in numerous peer reviewed publications. OraLiva is committed to delivering these capabilities chairside after the regulatory approval process is completed in the next few years.
How accurate is the test?
The test is 97% accurate, 94% sensitive and 92% specific in detecting cancer at the earliest stage (dysplasia)*. OraLiva’s diagnostic models match expert-level accuracy, with machine learning trained on over 13 million cells.
What are the liability implications of using the test?
Oral cancer misdiagnosis is the leading cause of malpractice litigation among dentists today. In fact, studies have shown that failure to diagnose oral cancer accounts for over 30% of dental malpractice claims in the United States. A significant contributing factor is the lack of trusted, accessible tools to evaluate suspicious lesions during routine exams.
OraLiva addresses this critical gap by equipping dentists with advanced diagnostic support that enhances clinical decision-making and streamlines referral management for oral lesions. As an adjunctive tool—not a replacement for scalpel or punch biopsy and histopathology—OraLiva empowers providers to identify high-risk cases more accurately and refer appropriately, ultimately reducing liability and improving patient outcomes.
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How common are suspicious red, white or mixed spots?
Over 10% of the population may present with red, white, or mixed oral lesions at any given time—findings that warrant further evaluation to rule out oral cavity cancer or oral epithelial dysplasia. However, distinguishing between common benign oral lesions and early-stage oral dysplasia—particularly mild or moderate dysplasia—can be extremely challenging, even for experienced specialists. These oral lesions often share similar clinical appearances, making visual inspection alone an unreliable method for risk stratification. This diagnostic ambiguity underscores the need for adjunctive tools like ORAL ONC In-CYT that can support more accurate assessment and guide timely, appropriate intervention.
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 ORAL ONC In-CYT 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.
What percent of suspicious lesions are considered oral potentially malignant lesions that require referral to expert care?
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 more careful evaluation. 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. Unfortunately, only 1 in 8 of the OPMDs are referred today for expert care and these patients that are referred are often very late stage disease.
Some practices use a light to screen for oral cancer. How is the OraLiva different from light-based tests?
Light-based screening tools highlight abnormal tissue, but don’t assess cellular changes. OraLiva ORAL ONC In-CYT test analyzes the actual cyto-signatures using carefully selected biomarkers, nuclear expression profiles, cell phenotype frequency, lesion appearance and risk factors. Using large one of a kind cytomics databases, OraLiva and partners have pioneered the development of what may be described as a ‘thermometer for oral cancer’. That is, a simple numerical index that reliably profiles oral lesion disease severity and offers a direct and specific assessment of patient risk. Providers using light-base solutions are encouraged to use OraLiva’s test on any lesions highlighted by the light-base tool.
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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.