Designing a strategy to implement methylation tests in the Dutch cervical cancer prevention and diagnostics market

Abstract

Cervical cancer is a cancer that is largely preventable, which is already addressed through screening programmes and diagnostic pathways. However, current programmes and pathways have their limitations. The current test is subjective, labour intensive, and contributes to unnecessary referrals and overtreatment, which creates an extra burden on patients and the healthcare system. These limitations create a need for an improved test which addresses these limitations. A solution is the methylation test, however, implementing a new test in the healthcare system is not simple.

This graduation project explored how the methylation tests could be positioned and implemented in the cervical cancer prevention and diagnostics market. This is explored in collaboration with Self-screen, that develops the methylation tests. Methylation tests are a promising alternative since they are objective, support better risk stratification, can reduce unnecessary referrals and treatments and are effective on self-samples.

Although the scientific evidence for methylation is strong, its adoption is still slow. The key challenge was how and where to position methylation in an already well-established healthcare system. Existing routines, limited awareness among gynaecologists, clinical guidelines, reimbursement and laboratory capacity all affect adoption.

This project followed a Double Diamond design approach and combined a literature review, stakeholder analysis, competitor analysis and interviews with different stakeholders. The findings from this research show that methylation tests are especially valuable in situations where the current test leaves uncertainty in the diagnostics of cervical cancer. Specifically in the situations where treatment should be avoided, such as younger women with a child wish and pregnant women. In addition, the research showed that the strategy should focus on increasing awareness, building trust and communicating the clinical added value of methylation tests to gynaecologists.

Based on these insights, a strategic and tactical roadmap for the gradual implementation of methylation tests is developed. Instead of implementation in the national screening programme, the proposed strategy focuses on implementation in cervical cancer diagnostics. This can be implemented more easily in the short-term and can help to create value earlier and build acceptance for later implementation in the screening programme. The designed roadmap is structured in three horizons. The first horizon focuses on creating awareness and identifying gynaecologist spokespersons. The second horizon focuses on sharing information with other gynaecologists through webinars and articles. The third horizon focuses on evaluating the use of methylation tests, improving the process and scaling the adoption by sharing results with more gynaecologists.

This strategy contributes to the implementation of methylation tests in the screening programme for cervical cancer, by first positioning methylation as a tool to support clinical decision-making in the diagnostics for cervical cancer. This strategy is effective since it supports clinical needs and decision-making processes, it fits within existing diagnostic workflows and enables the use of the test in practice. By first introducing the methylation tests in diagnostics, awareness and trust among gynaecologists can be built. This way, a strong foundation can be created for the long-term integration into the Dutch cervical cancer screening programme.