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To date, no studies have successfully shown that a highly specific, blood-based tumour marker to detect clinically relevant HPV-induced disease could be used for screening, monitoring therapy response or early detection of recurrence. This study aims to assess the clinical performance of a newly developed HPV16-L1 DRH1 epitope-specific serological assay. In a multi-centre study sera of 1486 patients (301 Head and Neck Squamous Cell Carcinoma (HNSCC) patients, 12 HIV+ anal cancer patients, 80 HIV-positive patients, 29 Gardasil-9-vaccinees, 1064 healthy controls) were tested for human HPV16-L1 DRH1 antibodies. Analytical specificity was determined using WHO reference-sera for HPV16/18 and 29 pre- and post-immune sera of Gardasil-9-vaccinees. Tumour-tissue was immunochemically stained for HPV-L1-capsidprotein-expression. The DRH1-competitive-serological-assay showed a sensitivity of 95% (95% CI, 77.2-99.9%) for HPV16-driven HNSCC, and 90% (95% CI, 55.5-99.7%) for HPV16-induced anal cancer in HIV-positives. Overall diagnostic specificity was 99.46% for men and 99.29% for women ≥ 30 years. After vaccination, antibody level increased from average 364 ng/ml to 37,500 ng/ml. During post-therapy-monitoring, HNSCC patients showing an antibody decrease in the range of 30-100% lived disease free over a period of up to 26 months. The increase of antibodies from 2750 to 12,000 ng/ml mirrored recurrent disease. We can also show that the L1-capsidprotein is expressed in HPV16-DNA positive tumour-tissue. HPV16-L1 DRH1 epitope-specific antibodies are linked to HPV16-induced malignant disease. As post-treatment biomarker, the assay allows independent post-therapy monitoring as well as early diagnosis of tumour recurrence. An AUC of 0.96 indicates high sensitivity and specificity for early detection of HPV16-induced disease. The manufacturer provided assays free of charge. Copyright © 2020 The Author(s). Published by Elsevier B.V. All rights reserved.


Thomas Weiland, Alexander Eckert, Peter Valentin Tomazic, Axel Wolf, Prisca Pondorfer, Sarah Vasicek, Matthias Graupp, Clemens Holzmeister, Ulrich Moser, Alexandros Andrianakis, Georg Kangler, Peter Kiss, Luka Brcic, Matthias Kappler, Claudia Wickenhauser, Anja Haak, Maximilian Krüger, Bilal Al-Nawas, Sebastian Blatt, Norbert Brockmeyer, Adriane Skaletz-Rorowski, Anja Potthoff, Lars E French, Sara Charnowski, Markus Reinholz, Andreas M Kaufmann, Sarah Thies, Hans-Georg Lambrecht, Barbara Seliger, Dominik C Wild, Dietmar Thurnher. DRH1 - a novel blood-based HPV tumour marker. EBioMedicine. 2020 Jun;56:102804

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PMID: 32535546

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