MDxHealth launches urine-based prostate cancer test
MDxHealth has launched a noninvasive, urine-based test, SelectMDx for Prostate Cancer, in Europe via the company’s state-of the-art laboratory facilities in Nijmegen, the Netherlands.
MDxHealth is offering SelectMDx patient testing initially in the Netherlands, with plans to expand the offering to other European countries in early 2016. In conjunction with the commercial launch of the test, MDxHealth and DDL Diagnostic Laboratory in Rijswijk, the Netherlands, have reached an agreement for the manufacture of CE-marked SelectMDx test kits.
DDL Diagnostic Laboratory, which is also the largest service provider of the existing prostate cancer PCA3 test in the Netherlands, has decided to discontinue processing of the PCA3 assay. As a result, MDxHealth anticipates that it will be the principal provider of urine-based prostate cancer testing for patients with elevated PSA levels (3.0–10.0 ng/ml) in the Netherlands.
The novel biomarkers that make up SelectMDx were discovered by Dr. Jack Schalken, original developer of the PCA3 assay, and his team at the Department of Urology at Radboud University Medical Center in the Netherlands. The SelectMDx test was designed to address an unmet need in the stratification of patients at risk for potentially lethal high-grade prostate cancer compared to those with low-grade cancer. In clinical studies, SelectMDx has been shown to outperform PCA3, improving the information available to urologists seeking to further reduce unnecessary invasive biopsy procedures.