Aquarius Population Health

Many national screening programmes for cervical cancer use human papillomavirus (HPV) testing to detect high-risk HPV (hrHPV) genotypes followed by liquid-based cytology (LBC) which looks for cytological abnormalities and can assess the need for colposcopy. One alternative to LBC triage is to use DNA methylation testing such as the QIAsure® FAM19A4/mir124-2 DNA Methylation Test (QIAGEN, N.V, Hilden, Germany), which detects hypermethylation of host tumour suppressor genes, a sign of oncogenesis.

Our peer reviewed article, compares the use of DNA methylation testing with LBC triage within cervical screening in The Netherlands, where both self-sampling and clinician-collected sampling are offered. The results indicate that, within an HPV primary screening programme which incorporates self-sampling, using DNA methylation testing for triage reduces the cost per screen compared to LBC triage.

Screening programmes are an essential public health tool which, in the case of cervical screening, they detect early signs of disease, preventing progression to cervical cancer. However, the success of any screening programme is dependent on high uptake and coverage. National cervical cancer screening programmes use a variety of approaches for reaching under-screened groups. Some settings have adopted a self-collected sampling approach for HPV primary cervical screening to complement traditional clinician-based sampling. However, a major limitation to self-collection is that, if the original self-collected sample is hrHPV positive, a second sample is needed for LBC triage. This additional step in the self-sampling pathway generates additional cost and can lead to loss to follow-up. DNA methylation assays such as the QIAsure® FAM19A4/mir124-2 DNA Methylation Test (QIAGEN, N.V, Hilden, Germany), can be used on self-collected samples, and could be used instead of LBC for triage in national screening programmes.

Using a decision tree model, we compared the costs of using LBC with using DNA methylation testing for triage within the Netherlands cervical screening programme, where self-sampling is available as an alternative to clinician-based sampling. It was informed with data from the Dutch cervical cancer screening programme, published studies, and manufacturer data, and used two alternative scenarios for the relative performance of DNA methylation and LBC, to account for uncertainties.

The study found that for the screening cohort (n = 807,269) where 22.1% self-sampled, the number of unnecessary colposcopies and CIN3+ diagnoses varied according to the relative performance of DNA methylation testing and LBC. Irrespective of relative performance, the cost per complete screen was lower and fewer people were lost to follow-up when using DNA methylation testing. The results indicate that, within an HPV primary screening programme that incorporates self-sampling, using the QIAsure Methylation Test for triage would reduce the cost per screen compared to LBC.

The analysis, first presented at Eurogin Congress in Bilbao in February 2023, was recently published as a peer reviewed article in Diagnostics and is freely available to read and download from the journal website.

Citation

Puri Sudhir K, Kagenaar E, Meijer M et al. Comparing the costs and diagnostic outcomes of replacing cytology with the QIAsure DNA Methylation Test as a Triage within HPV primary cervical cancer screening in The Netherlands. Diagnostics. 2023 Dec 6; 13(24):3612. doi:10.3390/diagnostics13243612 To learn more about our work at Aquarius, please visit our website or email us at info@aquariusph.com