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

Project description

Improved risk prediction of cervical cancer

Human papillomavirus (HPV) is responsible for cervical cancer, the fourth most prevalent type of cancer in women. DNA-based tests are used to detect HPV in cervical smears as a worldwide screening strategy. However, the DNA test alone cannot identify the infection cases that will clinically progress to cancer from those that will spontaneously regress. The EU-funded HPV OncoPredict project has developed a diagnostic device capable of detecting the high-risk HPV genotypes. The data is combined with other biomarkers as a more accurate way of stratifying women at risk of developing cervical cancer. The device is expected to reduce unnecessary treatments and associated healthcare costs.


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.

Call for proposal


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Sub call


Funding Scheme

SME - SME instrument


Net EU contribution
€ 1 670 000,00
Building e5 culham science centre
OX14 3DB Abingdon
United Kingdom

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South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 7 500,00

Participants (1)