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FDA Grants Breakthrough Designation to OraLiva Oral Cancer Test
- Source
- Dentistry Today
- Author
- Dentistry Today
- Originally at
- dentistrytoday.com(opens in a new tab)
Summary and scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol. Not the original publisher.
Why it matters for dental
FDA Breakthrough Device Designation for an investigational cytology test gives dental clinicians a future pathway for objective triage of suspicious oral lesions, potentially streamlining referral and biopsy decisions.
Key points
- 01
FDA granted Breakthrough Device Designation to OraLiva’s ORAL ONC-InCYT test, which produces an Oral Cancer Numerical Index from brush-collected cells.
- 02
OraLiva’s LDTs using the same platform are already available to dentists and specialists through its CLIA-certified lab in Durham, N.C., and have been offered since spring 2026.
- 03
ORAL ONC-InCYT is still investigational and has not been cleared or approved by the FDA; the designation provides a framework for closer agency interaction during clinical evidence generation.
- 04
OraLiva is exploring applications of its AI-enabled cytology platform in other epithelial cancers beyond oral lesions.
Who should care
- Owner
- Specialist
- Associate
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