OraLiva, Inc. announced the commercial launch of its AI-powered oral cancer and oral lesion test, a powerful non-invasive test designed to empower dentists and clinicians to detect and monitor lesions of concern earlier, when outcomes are most favorable. OraLiva has partnered with Delta Dental Plan of Michigan, Inc., Delta Dental Plan of Ohio, Inc., Delta Dental Plan of Indiana, Inc. (collectively “DDMI”), and Delta Dental of North Carolina (“DDNC”)1 on the launch to make the test available as a covered procedure.
The test, a “thermometer for cancer,” is intended for use by dentists, periodontists, oral and maxillofacial surgeons, and ENTs. Samples are collected quickly with a simple brush of the lesion during a routine clinical visit by hygienists or dentists. OraLiva’s test can also be used in surveillance testing of high-risk or recurrent patients and similarly be collected by nurses, trained assistants, or specialists.
Built on one of the largest NIH-sponsored prospective studies of oral potentially malignant disorders ever completed, with 999 patients and more than 13 million analyzed cells, OraLiva has developed and clinically validated one of the most advanced cytology models for the early detection and monitoring of oral cancer, uniquely capable of accurately distinguishing mild, moderate, and severe oral epithelial dysplasia (i.e., pre-cancer).2
Oral Cancer: Hiding in Plain Sight
Despite being visible in routine dental examinations, oral cancer remains one of the most difficult cancers to detect early because many benign oral lesions share features with oral epithelial dysplasia. This diagnostic challenge is compounded by the lack of effective, readily available tools to guide front-line clinicians when evaluating suspicious lesions.
In 2025, an estimated 59,660 Americans will be diagnosed with oral cancer, and approximately 12,770 will die from the disease.3 Unfortunately, only one in four cases of oral cancer are detected at an early stage, where five-year survival approaches 88%. Most cases are diagnosed at later stages of disease, when survival drops to approximately 37%, underscoring the urgent need for better early-identification tools.4
OraLiva’s test is designed not only to support the proactive detection of cancerous lesions but also to intercept disease earlier at the stage of precancerous dysplasia, when treatment is less invasive, survival prospects are higher, and healthcare costs are significantly lower.
A New Cytomics Platform for Early Detection
OraLiva’s test is powered by a novel cytomics platform that combines advanced microfluidics, high-resolution cellular imaging, and artificial intelligence to analyze cellular changes associated with early cancer development.
After collection by the provider, samples are shipped to OraLiva’s lab, where a proprietary microfluidic cartridge prepares the sample for digital cytology analysis. Once processed, the system generates high-resolution cellular images using OraLiva’s proprietary cellular imaging device, designed to capture detailed morphological and biomarker information from individual epithelial cells.
These images are analyzed by AI models trained on millions of oral epithelial cells and mapped to gold-standard adjudicated stages defined by leading oral pathologists. The models evaluate subtle cellular patterns associated with dysplasia and malignancy, enabling the system to detect abnormalities beyond the detection of the human eye.
The resulting test report, reviewed and approved by a pathologist, includes both a quantitative risk score, which measures the risk of the lesion, and an actionable recommendation to the provider on whether to rule out, monitor, or refer patients.
The technology was developed through more than a decade of translational research led by Dr. John T. McDevitt at the NYU College of Dentistry, in collaboration with experts in oncology, pathology, and biomedical engineering.
Access to Early Detection
OraLiva has partnered with Delta Dental of Michigan, Indiana, Ohio, and North Carolina to make the test available to providers in those states as a covered procedure under CDT code D7288 (brush biopsy, transepithelial sample collection). OraLiva expects to expand availability to additional states throughout the year as the program grows.
Dental providers interested in evaluating the technology in their practice can sign up for clinical evaluation kits here.
About OraLiva, Inc.
OraLiva develops AI-powered cytology diagnostics for early detection across epithelial tissues. Its oral lesion test combines microfluidic cytology collection, digital imaging, and artificial intelligence to generate clinically validated, risk-stratified reports and actionable recommendations that support clinical decision-making.
REFERENCES
- Delta Dental is a trademark of the Delta Dental Plans Association. The Delta Dental Plans Association does not make any representations, warranties or endorsements with respect to OraLiva or its products
- McRae, McDevitt, Journal of Dental Research, 2021, 100, 479-486.
- https://www.cancer.org/cancer/types/oral-cavity-and-oropharyngeal-cancer/about/key-statistics.html
- https://www.cancer.org/cancer/types/oral-cavity-and-oropharyngeal-cancer/detection-diagnosis-staging/survival-rates.html