QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today 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."