The QIAsure Methylation Test is intended to be used as a triage test for women with a positive HPV DNA test or for women with ASC-US cytology to identify those women who need to be referred for colposcopy.
The QIAsure Methylation Test is a multiplex real-time methylation specific PCR-based (qMSP) assay that detects hyper methylation of 2 disease related marker genes, FAM19A4 and mir124-2, to distinguish women with cervical (pre)cancer. The test specifically detects women with a cancer-like methylation profile, which are indicative for the women who have a short-term high risk for progression to cervical cancer.
The QIAsure Methylation test is a rebrand of the Precursor-M+.
After having identified women at risk by a positive HPV test, the majority of these women (~80-90%) will clear the HPV infection by their immune system and thus not develop cervical (pre)cancer. However, the smaller group of HPV positive women, who develop (pre)cancerous lesions need to be filtered out – this is called triage – by a test that identifies the women with a progressive lesion profile developing into (pre) cancer.
Therefore methylation marker based assays are an promising resolution while they comply with all of the above
Therefore a fully molecular test workflow is highly advantageous
A QIAsure triage solution improves clinical output while decreasing costs
Clinical Performance QIAsure on Rotor-Gene Q
|Clinical sensitivity cancer||98.3%|
|Clinical sensitivity CIN3+||78.6%|
|Clinical specificity CIN3+||76.8%|
|Reproducibility||• Overall agreement: 90%
• Kappa value: 0.76
Primary triage of HPV positive women
•Vink et al, Int J Cancer 2020 – FAM19A4/miR124‐2 methylation in invasive cervical cancer: A retrospective cross‐sectional worldwide study. https://pubmed.ncbi.nlm.nih.gov/31390052/
•Bonde et al, Int J Cancer 2020 – Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study. https://pubmed.ncbi.nlm.nih.gov/32997803/
Secondary triage in cases of ASC-US/ LSIL
•Dick et al, BMJ 2021 – Risk-stratification of HPV-positive women with low-grade cytology by FAM19A4/miR124-2 methylation and HPV genotyping. https://www.nature.com/articles/s41416-021-01614-4
•De Strooper et al, Int J Cancer 2018 – Cervical cancer risk in HPV‐positive women after a negative FAM19A4/mir124‐2 methylation test: A post hoc analysis in the POBASCAM trial with 14-year follow‐up. https://pubmed.ncbi.nlm.nih.gov/29663363/
•Dick et al, Gyn Onc 2019 – Long-term CIN3+ risk of HPV positive women after triage with FAM19A4/miR124-2 methylation analysis. https://pubmed.ncbi.nlm.nih.gov/31182225/
•Kremer et al, BMJ 2019 – Role of FAM19A4/miR124-2 methylation analysis in predicting regression or non-regression of CIN2/3 lesions: a protocol of an observational longitudinal cohort study. https://pubmed.ncbi.nlm.nih.gov/31289088/
•Kremer et al, J Clinical Oncology 2022 – Clinical regression of high-grade cervical intraepitehelial neoplasia is associated with absence of FAM19A4/miR124-2 DNA methylation (CONCERVE Study) https://ascopubs.org/doi/full/10.1200/JCO.21.02433
•Kremer et al, AIDS 2019 – The use of molecular markers for cervical screening of women living with HIV in South Africa. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6791588/
•Vink et al, Tumor Markers and Signatures, 2021 – Classification of high-grade cervical intraepithelial neoplasia by p16ink4a, Ki-67, HPV E4 and FAM19A4/miR124-2 methylation status demonstrates considerable heterogeneity with potential consequences for management. https://pubmed.ncbi.nlm.nih.gov/33729551/
•Hampl et al, IJC 2022 – Evaluation of managing CIN3+ diagnosed pregnant women by methylation using QIAsure Methylation Test. https://onlinelibrary.wiley.com/doi/10.1002/ijc.34153
•Vink et al, Clin. Inf Diseases 2022, FAM19A4/miR124-2 methylation testing and HPV16/18 genotyping in HPV-positive women under the age of 30 years
•De Strooper et al, Gyn Oncol 2016 – Validation of the FAM19A4/mir124-2 DNA methylation test for both lavage- and brush-based self-samples to detect cervical (pre)cancer in HPV-positive women. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4851217/
•Floore et al, J Clin. Lab Anal 20219 – Intra- and inter-laboratory agreement of the FAM19A4/mir124-2 methylation test: Results from an international study. https://pubmed.ncbi.nlm.nih.gov/30758084/
•Steenbergen et al, Nature Rev 2014 – Clinical implications of (epi)genetic changes in HPV-induced cervical precancerous lesions https://pubmed.ncbi.nlm.nih.gov/24854082/
•Kelly et al, Brit J Cancer 2019 – Performance of DNA methylation assays for detection of high-grade cervical intraepithelial neoplasia (CIN2+): a systematic review and meta-analysis https://pubmed.ncbi.nlm.nih.gov/31616037/
•Kremer et al, J Obs Gyn 2021 – The use of host cell DNA methylation analysis in the detection and management of women with advanced cervical intraepithelial neoplasia; a review https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/1471-0528.16395