NEW YORK — OraLiva announced that it has been awarded a two-year, $1.9 million grant from the National Institutes of Health to support the development and validation of its AI-powered diagnostic platform.
The grant, awarded by the National Institute of Dental and Craniofacial Research (NIDCR) under the NIH SBIR Phase II program, will support OraLiva’s work to advance a novel point-of-care platform for early detection and clinical management of oral potentially malignant disorders that affect millions of Americans but are often mischaracterized or overlooked in primary dental care.
The Durham, NC–based company will use the funding to further develop Onc In-Cyt, a “cytomics-on-a-chip” system that combines cytology with high-content imaging and deep learning to distinguish between benign and high-risk lesions using minimally invasive brush biopsy samples.
Each year, 54,000 Americans are diagnosed with oral cancer, yet only 28% of cases are detected early, when five-year survival exceeds 85%. Most are diagnosed late, when survival drops below 50% and treatment costs can exceed $100,000. Compounding the problem, over 10% of the U.S. population has an oral lesion, many of which may represent oral potentially malignant disorders that are precursors to cancer. OraLiva’s platform fills this critical gap by enabling dental providers to identify and monitor high-risk lesions more accurately and efficiently during routine care.
In earlier NIH-supported studies, OraLiva’s platform profiled over 13 million indexed cells from ~1000 patients across a 4-site international trial, uncovering 128 novel cytological features that outperform traditional markers in classifying oral epithelial dysplasia and squamous cell carcinoma.
OraLiva will use the grant to design and build instrument units combining all platform features into a stand-alone device suitable for both commercial use and clinical research. In addition, the company will finalize specifications for a future regulated point-of-care diagnostic system.
“This NIH award is an inflection point in our mission to deliver noninvasive oral cancer diagnostics directly into the hands of dental providers,” said Spencer Price, Chief Operating Officer at OraLiva. “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.”
OraLiva’s platform is currently offered as a laboratory-developed test (LDT) through its CLIA-certified lab. The NIH funding will help accelerate the company’s roadmap toward a regulated, widely distributed point-of-care diagnostic device, enabling frontline dental providers to detect and manage high-risk oral lesions during routine visits.