Qiagen has launched QIAsure Methylation Test, which is a CE-Marked molecular diagnostic method for identifying the risk of developing cervical cancer in patients.
The QIAsure Methylation Test is complementary to HPV screening tests and can be used after either a positive high risk HPV test or detection of abnormal cells in cytology through a Pap smear test.
It can be used on either clinician collected or self-collected samples.
The presently available triage options such as HPV genotyping or tissue-based assays come with limited clinical value. In several cases, these options lead to false positives or even miss the cervical disease.
QIAsure testing can stratify cervical cancer risk by detecting and measuring DNA methylation of two particular genes in cervical cancer.
In studies, the DNA markers used in this assay have shown reliable insights into a patient’s individual risk. This helps in surveillance and treatment decisions.
Qiagen senior vice-president and head of molecular diagnostics business area Thierry Bernard said: “QIAsure is a highly attractive and complementary addition to our leading HPV franchise.
“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.”
Qiagen chief medical officer Dr Tadd Lazarus said: “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.
“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.”
Approximately 500,000 women are globally affected by cervical cancer every year.
It is the third-most-common malignancy in women after breast and colon cancer.
Cervical cancer is caused by human papillomavirus (HPV).