In 2023 there was an estimated 13,960 women diagnosed with cervical cancer in the US, with roughly 3,200 new cervical cancer cases documented in the UK every year.
The NHS Cervical Screening Programme (NHSCSP) has evolved rapidly since the first screening programme. By introducing computerised invitation call/recall systems, liquid-based cytology and the Human Papillomavirus vaccination and testing programme the NHSCSP has a coverage of at least 80% of eligible individuals across England.
The current screening model is supported by clear administrative and clinical protocols. This not only reinforces the accuracy and quality of diagnosis but also ensures that individuals are called in advance to maximise early diagnosis too.
Throughout history, several barriers have been presented which have reduced attendance rates of cervical screening appointments; from anxiety related reasons, lack of education regarding the relevance of screening, and accessibility issues ranging from cultural, lingual, and religious pressures.
As part of the healthcare arena, RDi are passionate about helping patients access diagnostic pathways which facilitate their individual preferences whilst also accelerating the means of detection and treatment of health risks.
In our latest insight, we’ll detail the most important takeaways from 2024’s NCI cervical cancer initiative which aims to overcome the low screening attendance rates and the irregularities in attendance of consistent screening calls.
Why is early detection of HPV important?
Human Papillomavirus is a common virus which effects roughly eight in ten people. There are over 150 strains of HPV with an estimated 14 types of strains which are of high risk to evolve into cervical cancer. HPV 16 and HPV 18 cause 70% of all cervical cancer cases, so by screening for, and diagnosing, the most commonly associated HPV strains we can identify, monitor and treat precancerous cells with a broader scope of therapeutics and medications.
Introduction of the NCI Cervical Cancer SHIP Trial 2024
With an undisputed importance, it’s surprising that ‘over half of all cervical cancer cases diagnosed in the US occurred in individuals who have never been screened or who are infrequently screened’ according to the NCI Cervical Cancer Initiative.
Here is where the NCI (National Cancer Institute) and their cervical cancer initiative enter the realm of screening. In a bid to overcome some of the most common hurdles with screening attendance, the NCI have explored an alternative approach of self-collection.
Known to medical device manufacturers as at-home sample collection kits, the NCI cervical cancer initiative is focused on supporting a U.S. based study to understand the acceptance, usability, accuracy and effectiveness of a self-collection sample approach to HPV testing.
The initiative is also known as SHIP (Self collection for HPV testing to Improve Cervical Cancer Prevention). The SHIP trial involves the NCI creating partnerships with a range of private and public societies to potentially update the clinical guidelines to account for an integrated self-collection approach to cervical cancer screening.
How does the NCI cervical cancer initiative affect the key players in healthcare?
Self-collection of biological samples is not an uncommon practice in today’s modern diagnostic approach. Transferring the benefits of broader accessibility, comfortable collection environments and convenience to cervical cancer screening may just transform the staggeringly low percentages of uptake in gynaecology, doctor and clinic screening appointments.
If the SHIP initiative leads to regulatory approval of HPV sample collection devices, testing and diagnosis, there are a number of indirect effects that may occur in the healthcare chain.
The end-user
The SHIP trial has been brought to the United States with the purpose of catering screening to the end user. Existing methods have proved inefficient when it comes to driving accessibility, with underserved and high burden populations being key root causes of inadequate screening rates.
The utility of both clinic-based and population-based screening strategies could create a powerful approach to cervical cancer prevention, detection and treatment. The end user may one day be able to choose an HPV testing method that suits their preferences whilst still being able to achieve a quick, accurate and safe diagnosis.
The diagnostic labs
Assay manufacturers and R&D specialists will be required to shift their focus to assessing the suitability and sufficiency of HPV assays and testing methods. Ensuring they not only account for the new wider scope of samples collected, primarily those collected by the end-user at home.
HPV testing must also be deemed accurate and effective in the detection and diagnosis when it comes to self-collected samples.
This means that diagnostic laboratories, both clinical and nonclinical, embark on a journey of research into whether the samples collected at home are viable and if the HPV assays developed are coherent with these new samples.
If the NCI cervical cancer initiative unfolds as anticipated, laboratories should anticipate a surge in the number of received samples. In turn, this should enhance global population accessibility to screening.
The regulatory bodies
In this instance, the FDA will be primarily concerned with creating a pathway of communication between the laboratories and the regulatory bodies.
Should diagnostic labs and HPV assay manufacturers deem the testing and screening method to be effective for diagnosis of precancerous HPV cells, they will begin to seek approval of the self-collection screening method.
The SHIP trial is centred around independent assessment. An unbiased evaluation of the at-home HPV screening method will include research into not only the number of accurate test results but also the self-collection devices, the individual clinical participants in the multicentre trial, and the data collected by public and private stakeholders.
If the NCI’s cervical cancer initiative and the SHIP trial achieve its aims to increase HPV assessments and screening access, then the FDA along with other regulatory bodies will begin to build a repository of resources, approved medical devices and updated clinical practice guidelines.
The device providers
The accuracy and compatibility of the self-collection device to HPV assays is of primary concern to market-leading medical device and kitting manufacturers. The NCI cervical cancer initiative and SHIP trial is non-competitive, as all parties involved aim to bring the patient closer to early diagnosis and treatment.
This would result in several cervical cell sample collection kits being designed, manufactured and trialled. There will be a number of cross-sectional studies to investigate the collection devices and their compatibility with HPV testing methods. Ultimately, these devices will need to navigate two milestones:
- Designed as user-friendly, UN3373 compliant and effective for use in a home environment
- Gather sufficient sample volume for accurate HPV testing with various developed assays
RDi have been designing, manufacturing, and delivering custom and regulatory standard sample collection kits for over a decade. We have played pivotal roles in a number of programmes supporting the early detection of cancer, our relationship with the bowel cancer screening programme in England goes back well over a decade, producing many millions of kits and specimen transport solutions, most notably the safeTfit.
The regulatory approval of the SHIP trial would bring a new duty of the kit providers to launch fulfilment chains of the self-collection kits. Integrating the supply chain with the kit manufacture can be achieved through RDi’s pharma services.
Here, we embed automation and data-led decision making to allow screening programs to effectively track kit usage through lab receival traceability, all whilst incorporating packaging designs that encourage user completion.
Such value-added supply chain fulfilment services would provide far larger benefits to cervical cancer screening than if manufacturing and self-collection kit order fulfilment were delivered standalone. To discuss RDi’s core involvement in cancer screening further, get in touch with our team.
