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QIAsure Methylation Test validated as triage strategy for HPV positive women in a large multicenter European study

Due to the 3-fold increase in referrals in primary HPV screening, improved triage strategies for HPV positive women are desired. This new study, recently published in the International Journal of Cancer (Bonde et al, Int. J. Cancer. 2020;1–10.), demonstrates QIAsure methylation test (FAM19A4/miR124-2 methylation test) as a good substitute or addition to current cytology based triage methodologies. As part of the Valid-screen project, a grant of the EU in the Horizon 2020 program, the QIAsure Methylation Test was evaluated retrospectively in 2384 HPV-positive cervical screening samples, from women 29-76 of age, derived from four EU countries. Specimens were collected in ThinPrep or SurePath media, HPV-status, concurrent cytology, and histology diagnosis were provided by the parent institutes. A clinical well performing triage assay should have a high clinical sensitivity and specificity for (pre)cancer and a good PPV and high NPV. Overall sensitivity for the QIAsure Methylation Test for CIN3 was 77.2%  with a specificity of 78.3% (≤CIN1). PPV for ≥CIN3 was 28,3% and NPV for ≥CIN3 is 96.9% .

These clinically strong performance data support the use of the QIAsure Methylation Test for full molecular screening for cervical cancer, including primary HPV testing and triage testing by methylation analysis.