New Chairside Oral Swab Test Could Guide Biopsy Decisions in Oral Cancer

Oral squamous cell carcinoma can be difficult to triage at the point of care, resulting in frequent biopsies of lesions that ultimately prove benign. Limited access to pathology services in many communities can further delay diagnosis and treatment decisions. A rapid, noninvasive chairside assay could help clinicians identify lesions that warrant immediate biopsy and provide timely counseling. An academic–industry collaboration is now developing such a test for routine dental and primary care settings.

Case Western Reserve University is leading development of a noninvasive chairside assay, the beta-defensin index (BDI) fluorescence immunoassay (BDI-FIA), to evaluate oral squamous cell carcinoma (OSCC) using an oral swab. The test measures human beta-defensin-3 (hBD-3) and human beta-defensin-2 (hBD-2) and calculates their ratio, known as the BDI. Designed to provide results within minutes, the assay could help clinicians determine in real time whether a suspicious lesion warrants biopsy and support screening in settings with limited access to pathology.

The initiative brings together discovery research from the university’s School of Dental Medicine, device engineering and microfabrication expertise from the Case School of Engineering, and the commercialization capabilities of Hemex Health Inc. The project is supported by a five-year, USD 2.93 million National Cancer Institute (NCI) award structured as an academic-industrial partnership through the National Institutes of Health (NIH). Development plans include manufacturing the assay, analytically validating its precision and accuracy, and conducting clinical validation in patients, followed by efforts to pursue regulatory approval and commercialization in the United States and India.

The test builds on earlier university research examining human beta-defensins in the oral cavity. Investigators found that hBD-3 is overexpressed while hBD-2 declines in early OSCC, providing the biological basis for the BDI. The clinical need is substantial: the American Cancer Society estimates 60,480 new cases of oral and throat cancers and 13,150 deaths in the United States this year. In higher-income settings, about 90% of biopsied oral lesions ultimately prove benign, adding cost and patient anxiety. A rapid chairside triage test could help reduce unnecessary procedures while directing biopsy and pathology resources toward lesions most likely to be malignant.

“Our goal is to take a sophisticated laboratory measurement and engineer it into a simple, affordable device that works reliably at the chairside. Manufacturing and validating that device to a commercial standard is exactly the kind of translational engineering challenge our collaboration was built to solve,” said Aaron Weinberg, professor and chair of the Department of Biological Sciences at the School of Dental Medicine.

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