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Challenges and Solutions to Advance Cervical Screening

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Cervical cancer screening remains a critical aspect of women's health, significantly reducing the incidence and mortality associated with cervical cancer across Europe. Currently European screening programmes vary widely based on population specific requirements ranging from cytology-based to HPV-based or co-testing (cytology and HPV testing) programmes.

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The WHO has called for cervical cancer elimination by 2030. One of the pillars for achieving this is a target of at least 70% of women undergoing high performance cervical cancer screening by age 35 and 45. Europe’s Beating Cancer Plan aligns with the WHO goals. It aims to eliminate cervical cancer by expanding screening (90% of the target population offered by 2025), and improving access and awareness. 

It will use initiatives like the EU Cancer Screening Scheme to tackle HPV-related cancers through better data, gender-neutral policies, and addressing inequalities, making elimination achievable through strong implementation.

Automation and Screening Programmes in Europe

Over the past two decades, organised screening programmes in Europe have evolved, with new guidelines and emerging technologies reshaping their landscape. The current European Union guidelines recommend a shift towards HPV primary screening and emphasise population-based, quality-assured programmes. These programmes are essential for reducing cervical cancer burden by ensuring widespread, high-quality screening and follow-up, incorporating new technologies for greater reach and efficiency. 

HPV tests have a high sensitivity and negative predictive value for detection of cervical cancer and pre-cancer,1  which gives programmes the ability to offer reassurance to women testing negative for HPV infection. However, as a high proportion of screen positive women are expected to be identified, the EU screening guidelines recommend using HPV tests along with cytology based triage. This means that women who test positive for HPV need careful management as the majority of infections will clear naturally.

Choosing an HPV Test 

HPV assays detect either HPV DNA or HPV mRNA. Detection of mRNA allows the identification of active infections, offering a higher positive predictive value for the infections most likely to progress to precancerous lesions, thereby identifying active infections and unnecessary recalls for colposcopy. 

Multiple, robust studies with up to 10 years of follow-up data and real world evidence from screening programmes show that the HPV mRNA assay (Aptima® HPV) has high sensitivity and specificity for the detection of cervical pre-cancer.2–14  It detects E6-E7 oncogenes from 14 high-risk HPV types providing higher specificity compared to traditional DNA assays. 

These data support the use of HPV mRNA assays with their high specificity and positive predictive value, which are essential to avoid overcalling, which can lead to unnecessary follow-ups and anxiety for patients.1

Key Challenges for Laboratories

As HPV primary based cervical screening programmes are implemented or scaled up, laboratories face the challenge of implementing new technologies, processing increasing sample volumes and ensuring high quality of programme delivery. This will require significant adaptation by laboratory services including updated infrastructure, staff training, and careful management of the transition to HPV testing to ensure continuity and quality of care. 

Reliable molecular HPV tests backed by scientific rigour, clinical evidence and real-world data, automation for high-throughput adaptability, and standardised workflows are essential to maintain quality and efficiency. 

Technology continues to innovate with solutions such as the Genius™ Digital Diagnostics system for AI-guided digital cytology which combines with established solutions such as the market- leading ThinPrep® Pap test, the fully automated Panther® system and the Aptima HPV assay. These systems can process large numbers of samples efficiently and reliably. 

Automation with combined scalability not only increases throughput but also allows the use of the same sample for both HPV and cytology testing when required, delivering a seamless, end-to-end solution that improves laboratory productivity and reduces turnaround times. It also supports quality assurance measures, such as built-in process controls and sample traceability, which are essential for large-scale screening programmes.15

The Patient Perspective: Accuracy, Trust, and Screening Uptake

From a patient perspective, the adoption of advanced HPV screening technologies translates into fewer misdiagnoses and unnecessary procedures. High-specificity tests mean an accurate diagnosis, less anxiety, and increased trust in the screening process. When women are confident in the accuracy of their results, they are more likely to participate in regular screening, which is crucial for women’s wellbeing and for achieving optimal public health outcomes.

Conclusion

As European cervical screening programmes continue to evolve, the integration of high-quality molecular testing and laboratory automation will be key to overcoming current and future challenges. The combination of established and innovative new technologies not only improves efficiency, but also strengthens women's trust in the healthcare system, driving higher screening rates and ultimately leading to better health outcomes across the continent.

To learn more, visit our Cervical Health Solution page.

For more insight articles, visit the Hologic Innovation Exchange.

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    References
    1. Arbyn M, Simon M, de Sanjosé S, Clarke MA, Poljak M, Rezhake R, et al. Accuracy and effectiveness of HPV mRNA testing in cervical cancer screening: a systematic review and meta-analysis. Lancet Oncol. 2022 July;23(7):950–60. 
    2. Cook DA, Smith LW, Law J, Mei W, van Niekerk DJ, Ceballos K, et al. Aptima HPV Assay versus Hybrid Capture® 2 HPV test for primary cervical cancer screening in the HPV FOCAL trial. J Clin Virol Off Publ Pan Am Soc Clin Virol. 2017 Feb;87:23–9. 
    3. Iftner T, Neis KJ, Castanon A, Landy R, Holz B, Woll-Herrmann A, et al. Longitudinal Clinical Performance of the RNA-Based Aptima Human Papillomavirus (AHPV) Assay in Comparison to the DNA-Based Hybrid Capture 2 HPV Test in Two Consecutive Screening Rounds with a 6-Year Interval in Germany. J Clin Microbiol. 2019 Jan;57(1):e01177-18. 
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