FDA Grants Breakthrough Designation to OraLiva Oral Cancer Test
Investigational cytology test is designed to help clinicians assess suspicious oral lesions with a quantitative index. OraLiva, Inc., an early cancer detection company developing AI-enabled cytology diagnostics, recently 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 a 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 dia...
