The QIAsure - Methylation Test
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+.
Why QIAsure Methylation Test?
- Because HPV primary screening ‘only’ identifies women at risk. Effective triage is mandatory to identify in this risk population those women with underlying disease.
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.
- Because current triage strategies are not ideal to do the above. Current triage strategies
- Are lacking a good clinical sensitivity and specificity for disease
- Do not guide clinicians to clear decision making
- Are subjective while labor intensive
- Induce over diagnosis, over referral and overtreatment
Therefore methylation marker based assays are an promising resolution while they comply with all of the above
- Because manageable lab workflows are essential in high volume screening programs
Therefore a fully molecular test workflow is highly advantageous
- Because the burden on health care systems is unnecessary growing without a change towards better triage model
A QIAsure triage solution improves clinical output while decreasing costs
What makes the QIAsure Methylation test unique?
- The QIAsure Methylation Test is clinically validated among several European patient cohorts and laboratories. It demonstrates good clinical sensitivity, clinical specificity and highly reproducible intra- and inter laboratory performance..
Clinical Performance QIAsure on Rotor-Gene Q
- Clinical sensitivity cancer : 98.3%
- Clinical sensitivity CIN3+ : 78.6%
- Clinical specificity CIN3+ : 76.8%
- NPV : 96.9%
- PPV : 28.2%
- Reproducibility : • Overall agreement: 90% • Kappa value: 0.76
- Very high sensitivity for cervical cancer (independent of histotype, FIGO, and geography) and CIN3+.
- Long term risk cancer significantly lower than cytology (long term CIN3+ risk equal)
- Highest number of clinical publications (Validscreen)
- An internal sample control checks for sample quality assuring reliable results.
- The QIAsure Methylation Test is validated for different sampling types, i.e. physician-taken cervical scrapes and self-collected vaginal specimens, and for different collection media, i.e. PreservCyt® and SurePath®.
- The QIAsure Methylation Test is compatible with the RotorGene Q, ABI7500 and VIIA7 platforms.
Clinical use cases for QIAsure methylation Assay
- Triage test for
- hrHPV-positive women
- ASC-US/LSIL population
- Reassurance test: a negative QIAsure result indicates a very low risk of developing (pre)cancer (1.7% ref) .
- Guidance to clinicians: a positive QIAsure result indicates follow up by colposcopic examination of the cervix by a health care professional to guide patient management. A negative QIAsure result allows safe monitoring preventing unnecessary follow up and overtreatment
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