External Validation of Straticyte™, a Quantitative Biomarker-Based Risk Assay in Predicting Oral Cancer

Current management of oral potentially malignant disorders (OPMDs) based on dysplasia grading is controversial. The malignant transformation rate of OPMDs does not correlate well with dysplasia grading, resulting in non-standardized treatment for patients. A quantitative biomarker-based risk score (qBRS; trade name StraticyteTM) was previously developed to address shortcomings related to the current standard of care. A multicenter, retrospective cohort study consisting of biopsied OPMDs was used to validate qBRS for predicting transformation of OPMDs to OSCC.

Three hundred and two cases were immunostained, imaged, and analyzed via qBRS. A binary prognostic risk was determined using a receiver operating characteristic curve optimizing sensitivity and specificity. Kaplan-Meier analysis was used to estimate the cumulative probability of lack of malignant transformation for patients with elevated or normal biomarker-based risk.

The results demonstrated very high sensitivity (96.2%) and negative predictive value (96.2%) for qBRS. Elevated risk scores had higher predicted probabilities of transformation to cancer, independent of dysplasia grade.

qBRS can be a useful clinical adjunct tool to dysplasia grading for the assessment of malignant transformation potential, providing a quantitative metric in OPMDs. The addition of qBRS to current histological techniques should improve early detection rates of OSCC, enhancing the effectiveness of treatment.