Dear Colleagues,

The extraordinary advances in Human Papillomavirus (HPV) molecular diagnostics underpin equally remarkable advances in the prevention, management, and understanding of HPV-associated diseases. The implementation of high-risk HPV testing in cervical cancer screening programs represents an excellent example of how a molecular test has contributed to reduce the burden of an HPV-associated disease. Direct and indirect HPV tests have also become fundamental in the routine clinical work up of oropharyngeal cancer patients.

HPV molecular tests have an equally determining role in research settings. They are of prime importance in elucidating the natural history of HPV infection at genital and non-genital sites, and in investigating possible type replacement upon implementation of prophylactic HPV vaccines. Although HPV is not a clinically significant biomarker for patients with non melanoma skin cancer, HPV detection methods were key to the dissection of the role of cutaneous HPVs in this neoplasia.

In spite of a plethora of well-consolidated applications, the field of development and utilization of HPV-based molecular assays is continuously evolving. The availability of new technologies, the expanding number of newly discovered HPV types, as well as the expanding role of HPV infection in human disease are fuelling new efforts in this field. The new technologies, such as Next Generation Sequencing, have the ability to provide a previously unthinkable level of information, being able to characterize the analyzed samples in terms of viral load, HPV physical status, possible integration sites, and host genome alterations at such sites.

However, new fields of HPV research, possible novel clinical applications, and the increasingly wide number of HPV-based assays pose new challenges to laboratory approaches and to the standardization and clinical validation of pre-analytical and analytical phases. At the same time, a precise characterization and understanding of the analytical and/or clinical characteristics of the methods is needed to ensure the appropriate utilization by researchers and clinicians.

In order to broaden our knowledge of HPV infection and associated diseases, and to expand future applications of HPV testing methods for screening, diagnostic, and prognostic purposes, this Special Issue will focus on the laboratory, research, and clinical aspects of HPV molecular diagnostics. We welcome the submission of reviews and original articles regarding the use of tests for HPV-related biomarkers (DNA, mRNA, viral and cellular proteins, e.g., p16ink4A), in order to better understand HPV infection (e.g., lifecycle, natural history, virus-host interaction) and characterize HPV-induced lesions. Moreover, the Special Issue will focus on new technologies, such as Next Generation Sequencing and single-cell sequencing, in order to underline the contribution of such innovative technologies in the HPV field.

Dr. Anna Rosa Garbuglia
Dr. Maria Gabriella Donà
Guest Editors

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• Human papillomavirus
• High and Low risk HPV genotypes
• cancer
• molecular diagnostic
• Next generation sequencing