Development of a high-performance multi-probe droplet digital PCR assay for high-sensitivity detection of human papillomavirus circulating tumor DNA from plasma

Emerging role of blood‐based biomarker testing in HPV‐mediated head and neck squamous cell carcinoma

“…HPV ctDNA testing has a sensitivity of 89%-95% and a specificity of 95%-100% in detecting patients with previously untreated HPV-positive oropharynx cancer, which may constitute superior diagnostic performance in comparison with standard tissue sampling. [4][5][6][7] There is accumulating evidence supporting the use of HPV ctDNA in prognosticating, predicting treatment response, detecting minimal residual disease, and identifying recurrence in HPV-mediated HNSCC. 4,5,8,9 Although results from observation cohorts are promising, HPV ctDNA assays have not undergone rigorous validation across institutions or in prospective clinical trials.…”

“…To determine the reliability of HPV ctDNA assays in detecting minimal residual disease, it is critically important to understand test performance characteristics and reproducibility. Variability in test performance is likely related to the DNA detection method, tumor biology, and patient factors affecting clearance 7 . Therefore, although postsurgical HPV ctDNA positivity may identify patients who require further treatment, prospective studies are needed to elucidate whether treatment can be adapted on the basis of ctDNA alone or histopathologic analyses will be needed for confirmation.…”

“…In recent years, it has been demonstrated that HPV circulating tumor DNA (ctDNA) can also be detected in the majority of patients with HPV‐mediated HNSCC. HPV ctDNA testing has a sensitivity of 89%–95% and a specificity of 95%–100% in detecting patients with previously untreated HPV‐positive oropharynx cancer, which may constitute superior diagnostic performance in comparison with standard tissue sampling 4–7 . There is accumulating evidence supporting the use of HPV ctDNA in prognosticating, predicting treatment response, detecting minimal residual disease, and identifying recurrence in HPV‐mediated HNSCC 4,5,8,9 …”