Confidently stratify HPV-positive patient risk with QIAsure

When a patient tests positive for HPV, you want to understand her risk for cervical cancer. Implementing the QIAsure Methylation Test as a triage strategy can improve clinical assurance and reduce the risks associated with unnecessary colposcopies.

A breakthrough in patient health

Vaccination and screening are successful tools for preventing and detecting human papillomavirus (HPV) before it becomes a danger to a patient’s life or reproductive health (1). While most HPV infections are transient and resolve without treatment, a subset progress to cervical cancer.

The QIAsure Methylation Test aids in evaluating patient management options by accurately identifying patients with markers associated with the highest short-term risk for cervical cancer and reducing the risks associated with unnecessary colposcopies.

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“Effective triage of hrHPV positive screening samples constitutes one of the currently most crucial scientific issues to solve for primary HPV based screening to truly modernize cervical cancer prevention,” (2).
- Jesper Bonde, et al.

Confidence in your assessment

QIAsure is a quantitative methylation specific PCR (qMSP) test that accurately detects the presence of biomarkers associated with cervical carcinoma and advancing transforming cervical intraepithelial neoplasia (CIN).

More specifically, QIAsure looks for methylation of host cell genes FAM19A4 and miR124-2 in cervical-vaginal cells. Methylation of these genes indicates carcinogenic cell transformation and high short-term risk of developing cervical cancer, while absence of methylation indicates low short-term risk (2–6).

With these molecular insights, QIAsure can help reduce overreferrals and unnecessary treatments by stratifying patients who need immediate intervention versus those who need only monitoring.

Reliable detection across cervical histotypes

Independent research confirms the effective use of FAM19A4/miR124-2 methylation analysis for detection of cervical carcinomas and advanced CIN 2/3 lesions across cervical histotypes (3). Of 519 cervical cancer specimens tested retrospectively, 510 tested positive, yielding a positivity rate of 98.3% (95% CI: 96.7–99.2). Results were consistent across all histotypes.

Sensitive assessment of short-term and long-term cancer risk

Both retrospective clinical performance studies and long-term longitudinal studies have examined the performance of FAM19A4/miR124-2 (QIAsure) as a triage tool. QIAsure has been shown to be effective at identifying cancer risk over both the short and long term (2, 5, 6).

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Self-screen B.V. is the legal manufacturer of the QIAsure Methylation Test. QIAGEN is a distributor.