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

With funding support from European Commissions, Hiantis and GeneFirst team up to develop an innovative solution for screening and triaging women at risk of developing cervical cancer
The Problem

Cervical cancer is the fourth most frequently occurring cancer in women around the world, also affecting young women during their reproductive years, and estimated to kill 250,000 women annually.  Since the development of the Papanicolaou (Pap) test, screening has been essential in identifying cervical cancer at a treatable stage. With the identification of the human papillomavirus (HPV) as the causative agent of essentially all cervical cancer cases, HPV molecular screening tests and HPV vaccines for primary prevention against the virus have been developed. HPV is however the most commonly acquired sexually transmitted virus, with around four out of five people (80%) contracting this infection at some point during their lifetime. 

Currently 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 European countries, mainly as a result of social, economic and/or racial/ethnic barriers, hindering cervical cancer prevention in these women. This, together with current failure to implement gender-neutral HPV vaccination with high coverage in the great majority of countries,  have resulted in IARC’s projections showing that, unless innovative preventive measures are implemented promptly, the burden of cervical cancer is expected to increase to almost 460.000 deaths per year by 2040, an increase of nearly 50% over the estimated number of deaths in 2018.

Our Solution

HPV OncoPredict is unique in its power to discriminate clinically irrelevant from relevant high risk HPV infections leading to cancer by means of a high-throughput molecular reflex testing algorithm: 1) a screening assay able to detect all hrHPV infections, 2) a triage assay for hrHPV positive samples comprising of two second line biomarkers as indicators of risk, i.e. normalized hrHPV viral load (viral DNA copies/human cells) and viral-induced cellular oncogenic transcripts (E6/E7 mRNA). This innovative diagnostic device will also allow reliable testing on both self-collected vaginal and urine samples, maximising uptake of screening in all women.

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