DURHAM, N.C., October 30, 2026 – OraLiva, Inc., an early cancer detection company developing AI-enabled cytology diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to ORAL ONC-InCYT, an investigational test designed to help clinicians assess suspicious white or red oral lesions.
ORAL ONC-InCYT analyzes cells collected from the lesion with a brush, evaluating cellular morphology and biomarker-related features to generate a quantitative Oral Cancer Numerical Index (OCNI). The OCNI is designed to be interpreted alongside a clinician’s overall evaluation to support decisions such as specialist referral, biopsy, or escalation of care. The designation covers use in adults with lesions suspected to represent an oral potentially malignant disorder or an oral lichenoid condition.
More than 60,000 Americans will be diagnosed with oral cavity or oropharyngeal cancer in 2026, and more than 13,000 will die from it, according to the American Cancer Society. Too many cases are still caught late, often after a lesion has been watched for months because clinicians have lacked objective tools to help determine which lesions warrant escalation.
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. Designated devices are eligible for prioritized interaction with FDA experts during development and prioritized review of marketing submissions, with the goal of getting important innovations to patients sooner.
“Cancer is, at its core, a disease of cellular dysregulation, so the cells collected from a suspicious lesion carry some of the most direct evidence of what is happening in that tissue,” said John T. McDevitt, Ph.D., Chief Scientist at OraLiva. “ORAL ONC-InCYT is designed to capture those cellular signatures, combining cell morphology and biomarker-related features with deep learning to produce a quantitative index. We see cytosignatures as a distinct class of biomarker, complementary to the nucleic acid, protein and microbiome approaches the field has pursued for years, where reaching robust clinical validation has proven difficult. FDA brings rigor to that challenge, and Breakthrough Device Designation gives us a framework to work closely with the agency as we generate the clinical evidence needed to support marketing authorization.”
OraLiva’s Laboratory-Developed Tests Available Today
OraLiva’s deep-learning cytology platform powers a portfolio of oral lesion tests available today to dentists and specialists as laboratory-developed tests (LDTs), performed in the company’s CLIA-certified laboratory in Durham, N.C. OraLiva began offering its LDTs in spring 2026. With Breakthrough designation, OraLiva will work closely with the FDA as it pursues marketing authorization for ORAL ONC-InCYT.
“Clinicians are already using our laboratory tests to help evaluate suspicious oral lesions,” said Spencer Price, CEO of OraLiva. “Pursuing FDA marketing authorization for ORAL ONC-InCYT is how we aim to make this kind of cytology-based assessment available more broadly, and Breakthrough designation lets us work closely with the agency as we do it.”
Beyond oral lesions, OraLiva is exploring applications of its AI-cytology platform in other epithelial cancers.
ORAL ONC-InCYT is an investigational device, is not available for clinical use, and has not been cleared, approved, or otherwise authorized by the FDA. OraLiva’s laboratory-developed tests are performed under CLIA, have not been cleared, approved, or otherwise authorized by the FDA, and are not covered by the Breakthrough Device Designation. Breakthrough Device Designation does not change FDA’s requirements for marketing authorization or guarantee that authorization will be granted.
About OraLiva
OraLiva is empowering providers with tools for the future of early cancer detection. Its AI-enabled cytology laboratory-developed tests analyze simple, minimally invasive brush samples to generate a quantitative index that helps dentists and specialists evaluate suspicious oral lesions. OraLiva’s mission is to make early cancer detection possible at every level of care. Learn more at www.oraliva.com.
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Spencer Price
