DRH1 – Evaluating a blood-based marker for HPV16-induced tumors

Introduction In the USA, the incidence of HPV16-induced oropharyngeal carcinoma has recently surpassed that of cervical cancer. In this study, we assessed the performance of a novel blood-based assay in the detection and post-treatment monitoring of HPV16-induced oropharyngeal carcinoma.

Methods This non-interventional, prospective study included 34 head and neck cancer patients and 1064 CRP-negative controls. Patient sera were obtained at diagnosis and over a 28-month follow-up period after treatment initiation, resulting in a total of 166 samples for analysis. Samples were analyzed for the presence of anti-HPV16 L1antibodies using a newly developed rapid test based on the HPV16-L1-specific monoclonal antibody clone DRH1at diagnosis and during follow-up. To confirm HPV status, tumor specimens were checked for the presence of HPV DNA and p16expression. CRP-negative control sera were used to establish diagnostic specificity of the assay.

Conclusions A total of 20 tumors were found to be positive for HPV16 DNA. 19 of these 20 were also tested positive with the immuno-assay used here resulting in a sensitivity of 95 %. The diagnostic specificity of the assay was found to be 99.36 % in men and 99.29 % in women over 30 years. The majority with confirmed HPV16-induced carcinoma showed a decrease in DRH1 antibody levels of 30-100 % after treatment. A rise in DRH1 antibody levels from 2,750 ng/mL to 12,000 ng/mL was observed in one patient during follow-up, later tumor recurrence in the lung was diagnosed.

Conclusion The presence of HPV16 L1 DRH1 epitope-specific antibodies in patient blood is an indicator for HPV16-induced malignant growth. The immuno-assay used here provides a promising tool to track treatment response and may be used for the early detection of disease recurrence.

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Publication History

Article published online:
10 June 2020