Cervical cancer is the fourth most frequent cancer in women, estimated to kill 250,000 women annually. With the identification of the human papillomavirus (HPV) as the causative agent of essentially all cervical cancer cases, HPV molecular tests have been developed to allow screening for early disease detection. HPV is the most commonly acquired sexually transmitted virus, with around four out of five people contracting this infection at some point during their lifetime. Available HPV tests are unable to discriminate HPV infections regressing spontaneously from those turning into cancer. Screening refusal is also an important problem in several countries, resulting from social, economic and/or ethnic barriers, hindering cervical cancer prevention in these women. This, together with failure in many countries to implement gender-neutral HPV vaccination, has resulted in IARC’s projections showing that, unless innovative preventive measures are implemented, the burden is expected to increase to almost 460.000 deaths per year by 2040, an increase of nearly 50% over the number of deaths in 2018.
HPV OncoPredict is unique in its power to discriminate clinically relevant from irrelevant HPV infections by means of a high-throughput molecular reflex testing algorithm: 1) screening assay able to detect all oncogenic HPV infections, 2) triage assays for HPV positive samples comprising of two second line biomarkers as indicators of risk, normalized hrHPV viral load and viral-induced cellular oncogenic transcripts. This innovative diagnostic device will allow reliable testing on self-collected vaginal or urine samples, maximising screening uptake. HPV OncoPredict IVDs developed and validated as part of this project will help identify those women at true risk of developing cervical cancer. Risk-stratification will prevent unnecessary costly and stressful investigations and overtreatment of women with clinically irrelevant infections. Moreover, HPV OncoPredict assays will be clinically validated to ensure reliable results on both clinician-collected and self-collected samples, representing an important public health achievement as recent studies have shown that self-sampling improves adhesion of “non-responders” to screening programs, contributing to improved prevention and costs reduction for the health system.
