A Groundbreaking Stand-Alone Diagnostic Kit to Predict Human Papilloma Virus Infections Evolving into Cervical Cancer

Cervical cancer (CC) kills a 250,000 people annually, frequently affecting young women, and requires persistent infection with high-risk Human Papillomavirus (hrHPV) for its development. It is preventable, by HPV vaccination and the implementation of population screening programmes, and it is curable if detected and treated early. Despite overwhelming evidence that detection of viral nucleic acids (HPV testing) in cervical cellular samples allows earlier detection of CC as compared to cytology (Pap smear), it is feared that its use as a stand-alone test in CC screening would be responsible for over-diagnosis and over-treatment.HPV OncoPredict is an innovative diagnostic device (IVD) capable of detecting all oncogenic hrHPV genotypes frequently causing cervical infection as well as allowing to accurate identification those 10% of infected women who are truly at risk of developing cervical cancer. With the use of novel viral biomarkers, HPV OncoPredict, starting from a single self- or clinician-collected cellular sample, will enable women to undergo both primary cervical screening and, if HPV-positive, subsequent triage. HPV OncoPredict will allow HPV testing to reliably replace Pap smears in cervical cancer prevention, as recently recommended by European guidelines, being based on a disruptive technology ahead of any competitor’s product and supported by key opinion leaders. The HPV testing market is huge (€315 M) with around 100 million tests performed each year. The consortium formed by GeneFirst and Hiantis, both highly innovative companies with patented technologies, has the capacity to bring HPV OncoPredict to success. HPV OncoPredict will not only shape the manner in which we stratify women at risk of developing cervical cancer, but also provide an accurate and cost effective test of disease to benefit patients. More importantly, it will feed into how healthcare systems implement screening strategies to benefit patient pathways.