Each year, 54,000 Americans are diagnosed with oral cancer, yet only 28% of cases are identified at an early stage, when the five-year survival rate exceeds 85%. Most diagnoses occur in later stages, when survival drops below 50% and treatment costs can soar. Over 10% of the U.S. population has an oral lesion, many of which may represent potentially malignant disorders that often go undetected or mischaracterized during routine dental visits. The lack of effective tools for early identification and monitoring of high-risk lesions in primary dental care creates a critical diagnostic gap. Now, a novel solution equips frontline dental providers with a faster, more accurate tool to detect and manage these lesions during routine care.

OraLiva (Durham, NC, USA\) has developed Onc In-Cyt, an artificial intelligence (AI)-powered “cytomics-on-a-chip” diagnostic platform for early detection and clinical management of oral potentially malignant disorders. This point-of-care platform uses minimally invasive brush biopsy samples and combines cytology with high-content imaging and deep learning to differentiate between benign and high-risk lesions. In earlier studies, the platform profiled over 13 million indexed cells from approximately 1,000 patients across a four-site international trial, revealing 128 novel cytological features that outperformed traditional markers in classifying oral epithelial dysplasia and squamous cell carcinoma.

The platform is currently offered as a laboratory-developed test (LDT) through OraLiva’s CLIA-certified lab. OraLiva is working on the design and assembly of stand-alone instrument units that integrate all platform features, along with finalizing specifications for future regulated point-of-care deployment. The company plans to accelerate development toward a regulated, commercially available point-of-care device, allowing frontline dental providers to detect and manage high-risk oral lesions during routine visits.

“By equipping frontline clinicians with smart, scalable tools, we aim to shift diagnosis earlier—when treatment is more effective, less invasive, and significantly less costly,” said Spencer Price, Chief Operating Officer at OraLiva.

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