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The QIAsure Methylation Test

The QIAsure Methylation Test is a real-time PCR-based molecular assay to distinguish women with cervical (pre)cancer. The test specifically detects women with a cancer-like methylation profile that have a short term high risk for progression to cervical cancer. With that it can be used as triage test for women with a positive HPV DNA test or for women with ASC-US cytology to identify those women that need to be referred for a colposcopy. (ref1, 2, 3)

Special features of the QIAsure Methylation Test:

  • multiplex quantitative methylation-specific PCR (qMSP) test;
  • detection of hypermethylation of two disease-related genes (FAM19A4 and has-mir124-2);
  • provided with an internal sample control;
  • clinically and inter-laboratory validated in several European cohorts (Valid screen project);
  • high accuracy and reproducibility;
  • automated result analysis
  • compatible with cervical scrapings and self-collected (cervico-) vaginal samples
Clinical endpointFractionPositivity rate, % (95% CI)
≤CIN 124/117 20.5 (14.1–28.8)
CIN 2*16/4238.1 (24.8–53.4)
CIN 3*20/3066.7 (48.4–84.0) 
Squamous cell carcinoma 59/59 100.0 (94.0–100.0) 
Adenocarcinoma10/10
100.0 (69.0–100.0) 

Note: hypermethylation of the targets in samples of women harboring advanced CIN lesions and/or cervical cancer might remain undetected due to inadequate sampling.

Clinical endpointFractionPositivity rate, % (95% CI)
≤CIN 134/14823.0 (16.9–30.4)
CIN 2*7/2429.2 (14.6–49.8)
CIN 3*33/5066.0 (52.0– 77.7)
Squamous cell carcinoma 8/8100.0 (63.1–100.0)
Adenocarcinoma3/3100.0 (29.2–100.0)

* Not all CIN2 and CIN3 lesions will develop into cancer, the QIAsure Methylation Test specifically detects women with a cancer-like methylation profile that have a short term high risk for progression to cancer (ref 1).

Ordering information

Some extra information about ordering The test.