Breakthrough-Designated Cytology Test Supports Oral Cancer Risk Assessment

Suspicious white or red oral lesions may be monitored for months when clinicians lack objective tools to determine which cases require further evaluation. A newly designated investigational test now aims to provide quantitative cytology-based assessment of suspicious oral lesions.

OraLiva’s ORAL ONC-InCYT has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation. The investigational test is designed to help clinicians assess suspicious white or red oral lesions in adults, including lesions suspected to represent an oral potentially malignant disorder or an oral lichenoid condition.

The test analyzes cells collected from the lesion using a brush and evaluates cellular morphology together with biomarker-related features. These measurements are used to generate a quantitative Oral Cancer Numerical Index (OCNI), which is intended to be interpreted alongside the clinician’s overall assessment to support decisions such as specialist referral, biopsy, or escalation of care.

The FDA’s Breakthrough Devices Program is intended for medical devices that may provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions. Devices receiving the designation are eligible for prioritized interactions with FDA experts during development and prioritized review of marketing submissions. OraLiva plans to work with the agency as it pursues marketing authorization for ORAL ONC-InCYT.

OraLiva’s deep-learning cytology platform also supports a portfolio of oral lesion tests currently available to dentists and specialists as laboratory-developed tests. These tests are performed at the company’s Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory in Durham, North Carolina, and were first offered in spring 2026. ORAL ONC-InCYT remains investigational and is not available for clinical use. 

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