NEW YORK (GenomeWeb) – MDxHealth announced today that it has granted a non-exclusive worldwide license for its patented methylation-specific PCR (MSP) technology to Qiagen for use in its QIAsure assay, a CE-marked test for use in differentiating patients' risk of developing cervical cancer.
Under the terms of the agreement, MDxHealth will receive a signing fee plus royalties from future test sales utilizing the technology.
The molecular diagnostic test is complementary to human papillomavirus (HPV) screening tests, including Qiagen's HPV franchise, and follows either a positive high-risk HPV test or a finding of abnormal cells in cytology from a Pap smear. It can be used on either clinician-collected or self-collected samples.
According to Qiagen, 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.
"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," Tadd Lazarus, Qiagen's chief medical officer, said in a statement.