Performance of an Oral Rinse Point-Of-Care Assay to aid in the diagnosis of Head and Neck Squamous Cell Carcinoma (HNSCC) in a High-Risk Danish Ear-Nose Throat (ENT) Clinic

Objectives: Oral examination and biopsy are established methods for early detection of oral/oropharyngeal squamous cell carcinoma (OOSCC). The aim of the current study was to evaluate performance of a point-of-care (POC) assay to aid in the diagnosis of head and neck cancer. Materials and methods: 150 consecutive patients were enrolled from a high-risk ear nose and throat clinic at the Rigshospitalet in Copenhagen, Denmark. A positive POC test represented as a CD44 band or elevated level of total protein (TP) was correlated with biopsy results and then evaluated with sensitivity (Se), specificity (Sp), PPV, NPV and multivariate models. Results: 119 patients enrolled between January 2016 and April 2017. Presence of a CD44 band or TP ≥3: Se of 73% (95% CI 57.0–84.6%), Sp of 50% (95% CI 39.4–60.5%), and NPV of 94.77% (95% CI 84.12–98.33%). CD44 band or TP of ≥ 2 for non-smkers and ≥ 3 for smokers improved performance: Se 81% (95%CI 66–90%) and Sp 33% (95%CI 24–44%), NPV of 94%. Multivariate models with male gender and ≥ 60 years: Se of 84% (95%CI 67–92%) and Sp of 37% (95%CI 27–47%), NPV of 95%. Non-biopsied, healthy, non-smoking, females (n = 17): Sp of 78%. Conclusions: POC assay performed well for identifying OOSCC in a prospective clinical trial. Clinical features such as age, smoking status and gender are important variables in assessing risk. Additional studies are underway to further confirm these results including the incorporation of a version 2 POC device.