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DRH1 - a novel blood-based HPV tumour marker
Thomas Weiland1, Alexander Eckert2, Peter Valentin Tomazic1
1Department of Otorhinolaryngology-Head&Neck Surgery, Medical University of Graz, Auenbruggerplatz 26, 8036 Graz, Austria.
Ebiomedicine
|June 15, 2020
Summary
A new serological assay detects human papillomavirus type 16 (HPV16)-L1 DRH1 antibodies, showing high sensitivity and specificity for HPV16-induced cancers. This assay aids in post-therapy monitoring and early detection of tumor recurrence.
Area of Science:
- Oncology
- Virology
- Immunology
Background:
- No validated blood-based tumor marker exists for HPV-induced diseases.
- Human papillomavirus type 16 (HPV16) is implicated in various cancers.
Purpose of the Study:
- To evaluate the clinical performance of a novel HPV16-L1 DRH1 epitope-specific serological assay.
- To assess its utility in screening, therapy monitoring, and recurrence detection.
Main Methods:
- Multi-center study involving 1486 participants, including Head and Neck Squamous Cell Carcinoma (HNSCC) patients, HIV-positive anal cancer patients, and healthy controls.
- Serological testing for HPV16-L1 DRH1 antibodies.
- Immunochemical staining of tumor tissue for HPV-L1 capsid protein expression.
Main Results:
- The assay demonstrated 95% sensitivity for HPV16-driven HNSCC and 90% for HPV16-induced anal cancer in HIV-positives.
- High diagnostic specificity (99.46% for men, 99.29% for women ≥30 years).
- Antibody levels correlated with disease status, enabling post-therapy monitoring and early recurrence detection.
Conclusions:
- HPV16-L1 DRH1 epitope-specific antibodies are biomarkers for HPV16-induced malignancies.
- The assay is a valuable tool for independent post-therapy monitoring and early tumor recurrence diagnosis.
- High AUC (0.96) confirms excellent sensitivity and specificity for early HPV16-induced disease detection.

