The Netherlands started QIAsure Methylation Test implementation trial for triage of HPV positively screened women

With the introduction of HPV based screening in 2017 the Dutch cervical cancer screening program underwent an important improvement. More women at risk are being discovered due to the higher sensitivity of HPV assays compared to the old cytology based test program, but as a consequence the number of referrals after cytology based triage of HPV positive women has increased 3 times. The majority of these referrals appear unnecessary because the HPV positive cytology positive tested women often harbor an infection that will not cause high grade disease or cancer, but in fact carry a very low risk for severe disease. Therefore, in order to reduce unneeded burden to this group of women as well as the treating gynecologists and the health care system in general, new methods that can better identify CIN3+ in HPV positive women are urgently needed. This is why the RIVM (the Dutch Health Institute responsible for the National Cervical Cancer Screening program) is looking for improved triage strategies for HPV positive screened women.

QIAsure Methylation Test implementation trial for triage of HPV positive women.

Methylation patterns on the promoter regions of tumor suppressor genes involved in cervical cancer development have demonstrated to be sensitive biomarkers to detect cervical cancer and severe precursor stadia (CIN3+). The QIAsure Methylation Test is a clinically validated CE-IVD and commercially available assay with a clinical indication for

• Triage testing of HPV positive and/ or ASCUS/LSIL women
• Treatment guidance for women with high grade CIN

Therefore   to demonstrate the improved performance  over cytology, the QIAsure Methylation Test is presently tested within the context of the Dutch screening program. The study is conducted by Amsterdam UMC and Symbiant, one of the 5 national HPV screening laboratories. The objective of the study is to evaluate the clinical performance (detection of CIN3+) and colposcopy referral rate of QIAsure as triage tool of HPV-positive women compared to cytology after one year of follow-up. Sample enrolment of HPV positive women was initiated in December 2020. Results are to be expected early 2022. It is anticipated that triage by the QIAsure Methylation Test will reduce the colposcopy referral rate and the detection of benign and CIN1 lesions without compromising the sensitivity for CIN3 and cervical cancer compared to current cytology based practice and therewith reduce over-diagnosis and over-treatment.