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This retrospective cohort study evaluated the performance of a commercially available tissue-informed circulating tumor DNA (ctDNA) assay in patients with head and neck squamous cell carcinoma (HNSCC) across both pretreatment and surveillance contexts. Key findings include: a 92.2% assay creation rate in pretreatment analysis, and in surveillance settings, per-test sensitivity of 95.2%, specificity and positive predictive value (PPV) of 100%, and negative predictive value (NPV) of 99.4%. These metrics were mirrored on a per-patient basis. The assay showed excellent potential for sensitive, specific monitoring of both HPV-positive and HPV-negative HNSCC, particularly overcoming challenges of tissue-agnostic approaches in HPV-negative cases.
