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Human papillomavirus screening is critical to the early identification of women at risk of cervical cancer. Now EU-funded researchers have pioneered even more accurate and precise methods for the early detection of those who are at increased risk of developing the disease.

Cervical cancer is the second most common type of cancer in women aged between 15 and 44. Nearly all cervical cancers are caused by human papillomavirus (HPV) infections, which are spread through close skin-to-skin contact, usually during sexual activity.  The good news is that some 99.8 % of cervical cancers are preventable through HPV screening, early detection and vaccination.

Current screening limitations

Current screening procedures, however, present some challenges. Screening methods based on the detection of HPV are highly sensitive in detecting women potentially at risk, but do not allow for distinguishing transient and clinically irrelevant infections from those leading to cancer.  

This can lead to overdiagnosis and overtreatment of women, as well as additional costs for health systems.  

Another limitation is that whilst screening programmes are widely available in high-income countries, this is often not the case in low- to middle-income countries. Moreover, some women may fail to attend screening due to embarrassment, pain, inconvenience or a lack of understanding.  

“Most cases of cervical cancer today occur in women who do not have access to or who fail to attend screening programmes,” explains HPV OncoPredict project coordinator Winnie Wu, COO at GeneFirst.  

“The implementation of novel screening strategies based on reliable self-collected samples could therefore improve women’s participation and reduce health costs of screening programmes in both high and low-middle-income countries.”

Pioneering new techniques

The aim of the HPV OncoPredict project was therefore to improve on current processes, and examine ways of expanding coverage worldwide.  

This was achieved by developing diagnostic tests capable of more accurately identifying, among those screened, women with HPV infection who are at higher risk of developing cervical cancer. These tests will allow for implementation of personalised strategies for the management of HPV-positive women, thus avoiding more invasive investigations and treatment of women.  

The new tests have been validated using an automated workflow on a robotic platform as well as developing data analysis software, to ensure the reliable interpretation of test results.  

“Through the project, we were able to analytically and clinically validate the tests developed as part of the HPV OncoPredict project showing that they are sensitive, specific and accurate,” says Clementina Cocuzza, head of the HPV OncoPredict project scientific board.

Potential for self-sampling

Pilot testing carried out during the project has provided the team with excellent clinical data. Just as significantly, the project team was also able to show that self-sampling could be a viable alternative to clinician-collected sampling.  

This is highly relevant, as the WHO has recommended that self-sampling should be made an alternative screening option as a means of improving global coverage.  

“The pandemic has underlined the importance of building resilience to disruption,” notes Winnie.  

“Self-collection devices could help to expand the reach of screening to underserved populations that currently do not participate in screening and provide a safe environment for women to collect samples at home.”  

Furthermore, self-testing could help to address the backlog of screening tests accumulated during the pandemic. The final outcome of clinical studies involving the use of self-collection devices will provide critical evidence to support the use of such devices in effective screening strategies.  

In the meantime, the project team, consisting of GeneFirst and Hiantis, will continue to assess the economic viability and clinical utility of their testing innovations. “Ultimately, our aim is to implement this new screening pathway, to future-proof our healthcare systems,” says Winnie.