HPV infections play a crucial role in the aetiology of cervical lesions. Various molecular assays have been developed to detect HPV. HPV DNA testing is already being used for the management of cervical disease. While it is generally accepted that HPV DNA testing is more sensitive for detection of cervical disease compared with cytology, it is less specific in particular in younger age groups, largely due to the high prevalence of transient HPV infections. As a consequence, the appropriate framework for HPV testing is paramount to avoid unnecessary testing and follow up. There is a clear need to improve the specificity of HPV DNA testing, and this can be achieved at various levels, including HPV genotyping and viral load assessment. An alternative approach is to triage with some form of secondary biomarkers. Several biomarker options exists for this including (1) measuring HPV E6 and E7 mRNA transcripts, (2) alterations to methylation patterns of several genes, (3) alterations of viral and host genomes (4) detection of cellular proteins overexpressed in HPV infected cells.
Within this project, CERVIVA aims to address the need for additional triage markers for cervical screening through evaluation of a combined approach of HPV DNA, HPV mRNA, p16INK4A/ki67 and a novel panel of 20 mRNA biomarkers developed as part of an FP7 funded programme grant "AutoCast" in a colposcopy controlled study. The data generated from this colposcopy controlled study will support a primary screening algorithm of primary HPV testing followed by biomarker triage.
This will be the first study to evaluate all three biomarker sets in a single population.