QIAGEN Launches QIAsure Methylation Test to Determine Cervical Cancer Risk

QIAGEN N.V. has announced the launch of the QIAsure Methylation Test, a novel CE-marked molecular diagnostic test for use in differentiating patients’ risk of developing cervical cancer.

The QIAsure Methylation Test is highly complementary to HPV screening tests and follows either a positive high risk HPV test or a finding of abnormal cells in cytology from a Pap smear and can be used on either clinician collected or self-collected samples. Currently available triage options such as HPV genotyping or tissue-based assays often have limited clinical value, or are subjective and in many cases lead to false positives or missed cervical disease. QIAsure testing accurately stratifies cervical cancer risk by detecting and measuring DNA methylation of two specific genes implicated in cervical cancer. In large scale studies, the DNA markers used in this assay have demonstrated reliable additional insights into a patient’s individual risk and contributed to decisions on surveillance and treatment. The test is being presented to the public for the first time at EUROGIN 2016, the international conference for the European Research Organization on Genital Infection and Neoplasia, in Salzburg, Austria.

“QIAsure is a highly attractive and complementary addition to our leading HPV franchise”, said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “It creates a compelling solution for primary screening that includes the leading HPV primary screening test and leading solution for automated sample processing and molecular analysis of cervical samples.“

“The QIAsure Methylation Test is an important advance for women’s health. When a woman screens positive for HPV, or cytology shows abnormal cells, she is at risk of developing cervical cancer. The QIAsure test is the next logical step to assess this risk,” said Dr. Tadd Lazarus, Chief Medical Officer of QIAGEN. “This highly sensitive, specific molecular test identifies cancer specific epigenetic changes in cervical cells and enables the physician to assess whether the HPV infection is progressing toward cancer – a valuable insight that provides timely reassurance and guidance to treatment for each individual patient.”

Medical need in cervical cancer detection

Globally, cervical cancer affects approximately over 500,000 women annually and is the third-most-common malignancy in women after breast and colon cancer. Cervical cancer is caused by the human papillomavirus (HPV), and women can be screened for HPV – making the cancer highly preventable and treatable. The virus, however, is a common infection and in most cases HPV-infected cervical cells do not transform into cervical cancer.

HPV testing is generally accepted as being more sensitive but less specific than cytology for detecting cervical disease. However, the benefit of increased disease detection using HPV as a primary test also results in many positive HPV tests in patients without underlying cervical disease. A positive HPV test result calls for follow-up testing to differentiate each patient’s risk based on cellular effects of the infection. With increased interest and uptake of HPV testing as a primary test, the need for a suitable triage test following a positive HPV test is increasing.

The currently favored triage method for a positive HPV result is cytology. Cytology lacks sensitivity, is subjective, and skill dependent. As primary HPV testing and vaccination prevention methods are implemented, the number of patients with abnormal cells will decrease, and consequently cytology will be increasingly harder to perform. In some countries the lack of cytology infrastructure required for necessary triage is a barrier to adopting primary HPV screening. This makes a complete molecular solution highly desirable. And so the need for an accurate molecular test following a HPV-positive test result is clearly an unmet medical need.

QIAsure Methylation Test

The CE-IVD marked QIAsure Methylation Test is launching in Europe, Middle East and Africa for use on either clinician-collected or self-collected specimens, a benefit for women and healthcare systems because self-sampling can streamline processes and avoid unnecessary further medical intervention. The test has been validated on the Rotor-Gene^® Q MDx system, a PCR platform that is a member of the modular QIAsymphony family of automation solution.

QIAGEN collaborated with Self-screen BV, a biotech spinoff company of VU University Medical Center in Amsterdam, in developing this test. “We are pleased to partner with QIAGEN to make this new triage test available. The launch is a milestone for Self-screen, which has developed and validated innovative multiplex assay technologies based on the work of our scientists at VU University Medical Center. More importantly, the test is an improvement for women’s health, offering reliable risk stratification as a follow-up to HPV screening or cytology,” said Prof. Dr. Chris Meijer, Chief Executive Officer of Self-screen.

The QIAsure Methylation Test helps assess transforming HPV infections from non-threatening ones by detecting molecular changes known as methylation in promoter regions of host cell FAM19A4 and mir124-2 genes, which are hyper-methylated in cervical cancers. Current triage options are not ideal in stratifying risk: Genotyping of HPV16/18 lacks specificity, leading to false positive results; cytology lacks sensitivity, leading to missed cervical disease. By identifying hyper-methylation of these host cell genes, the QIAsure test provides highly sensitive and specific results for patients and clinicians.

QIAsure will be available in Europe in the later course of 2016.