No prospective study has been done. The NavDx blood test is a blood test for cancers associated with human papillomavirus (HPV) infection. These results demonstrate that NavDx accurately and reproducibly detects circulating TTMV-HPV DNA. The assay is associated with a certain degree of false negatives—approximately 5 percent based on their data. he appropriate interval for surveillance testing remains unclear. Ferrandino et al state that a prospective clinical validation study is needed.
Gunning A, Kumar S, Williams CK, Berger BM, Naber SP, Gupta PB, Del Vecchio Fitz C, Kuperwasser C. Analytical Validation of NavDx, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Cancers. Diagnostics (Basel). 2023 Feb 14;13(4):725. doi: 10.3390/diagnostics13040725. PMID: 36832208; PMCID: PMC9955790.
M. L. Lango, Circulating Human Papillomavirus Tumor DNA—Ready for Prime Time?
JAMA Otolaryngology–Head & Neck Surgery Vol. 149, No. 11
Chera BS, Kumar S, Shen C, et al. Plasma circulating tumor HPV DNA for the surveillance of cancer recurrence in HPV-associated oropharyngeal cancer. J Clin Oncol. 2020;38(10):1050-1058. doi:10.1200/JCO.19.02444PubMedGoogle ScholarCrossref
Ferrandino RM, Chen S, Kappauf C, et al. Performance of liquid biopsy for diagnosis and surveillance of human papillomavirus–associated oropharyngeal cancer. JAMA Otolaryngol Head Neck Surg. Published online July 9, 2023. doi:10.1001/jamaoto.2023.1937