QIAsure Methylation Test – a breakthrough solution in Women’s Health

Cervical cancer is the second most common cancer among women aged 15 to 44, affecting more than 500,000 women a year.1 Fortunately, it is almost 100% preventable through advanced screening and early detection of precancer before the disease becomes a danger to a patient’s life or reproductive health.

QIAsure, the new Women’s Health solution from QIAGEN, is a cervical cancer screening test that lets clinicians see what’s happening at a molecular level to determine whether cervical cells are actively transforming into cancer. This innovative test objectively detects the presence of biomarkers associated with cervical precancer and cancer in the PCR lab, using the same sample from an HPV or liquid-based cytology test. Whether the result is positive or negative, QIAsure can provide peace of mind for patients so they can live their lives safe, confident, and sure of their reproductive health.

QIAsure Brochures

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Making cervical cancer screening more effective and objective

Today, women have an 80% chance in their lifetimes of contracting high-risk HPV, the causal agent of cervical cancer. However, only 1 in 10 women with high-risk HPV will develop long-lasting infections that put them at risk for development of cervical cancer.2 There is growing need for an accurate molecular test to see beyond HPV and determine whether a patient has a high short-term risk of cervical cancer.

QIAsure delivers objective assurance that women are safe from cervical cancer following a positive high-risk HPV result or an abnormal cytology result.

QIAsure could:

  • Separate out patients with high-risk HPV infections that are transforming into cervical cancer from patients who have low short-term risk of developing cancer
  • Guide surveillance and treatment decisions
  • Prevent women with non-transforming infections from receiving unnecessary treatments

Accurate molecular testing from a simple sample

QIAsure has been developed for ease of use in primary screening scenarios, following a positive high-risk HPV result or an abnormal cytology result. QIAsure can be performed on the same sample used for primary screening (HPV and/or liquid-based cytology), as well as vaginal self-samples collected by patients.

How QIAsure works

QIAsure is a quantitative methylation specific (qMSP) test that looks for specific molecular biomarkers in cervical specimens to objectively detect the presence of biomarkers associated with cervical carcinoma and advanced transforming cervical intraepithelial neoplasia (CIN). The presence of these biomarkers (specifically hypermethylation of host cell genes FAM19A4 and miR124-2) indicates a carcinogenic cell transformation and a high short-term risk of developing cervical cancer.3–8 Absence of these biomarkers indicates a low short-term risk of developing cervical cancer. This test can be performed in the PCR lab through industry-standard methods of sample prep/extraction and automation platforms for analysis (clinically validated for Rotor-Gene® Q MDx instrument).

QIAsure has been shown to detect the transformation of cervical cells and advanced transforming CIN 2/3 lesions, even in patients with normal cytology.

Key Benefits of QIAsure

QIAsure is a quantitative methylation specific PCR test with high sensitivity and 100% accuracy in detecting biomarkers associated with cervical carcinoma in patients.

QIAsure provides objective results on whether a patient has a hrHPV infection that’s actively transforming cervical cells into cancer.

QIAsure can be performed on the same sample (self-sample or physician/OBGYN collected) as the primary screening HPV test.

QIAsure can help reduce unnecessary colposcopies and cervical treatments.

QIAsure can be performed on self-samples collected by the patient without a speculum exam, making it easy and convenient to be tested early and often.

QIAsure provides test negative patients with peace of mind that they have a low short-term risk of cervical cancer.

Veronica has a high-risk HPV infection and returns for her six-month follow-up appointment. A pap smear discovers abnormal cytology and she undergoes colposcopy to look for precancerous lesions. Low-grade lesions are present, however the level of short-term risk is unclear since there are no molecular insights into whether the lesions are actively transforming into cancer or could subside on their own. QIAsure is performed for more insight into what’s happening at a molecular level before making a clinical decision for Veronica. Veronica age 30
Sophie undergoes primary screening for HPV and discovers she is at risk for cervical cancer due to detection of high-risk HPV. QIAsure is performed on the same sample to look for the presence of precancer or cancer. QIAsure produces a negative result and the clinician schedules a six-month follow-up appointment. QIAsure separates transforming high-risk HPV infections from non-transforming infections so that Sophie can be confident she is safe from cancer. Sophie age 32
Emma has high-risk HPV, but normal cytology. A QIAsure test produces a positive result, indicating the presence of transforming precancer. Emma is sent straight to colposcopy and treated for advanced transforming precancerous lesions. Without the QIAsure test, she would have had to wait 6 months before being re-tested, putting her life and reproductive health at risk. QIAsure identifies transforming high-risk HPV infections that can be missed by cytology and genotyping so that Emma is safe from dangerous precancer that could have rapidly progressed to cancer. Emma age 34