CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
MDxHealth announced the commercial launch of its noninvasive, urine-based test, SelectMDx for prostate cancer, in Europe via the company’s 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, a 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 in the Netherlands of urine-based prostate cancer testing for patients with elevated PSA levels (3.0–10.0 ng/mL).
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.
MDxHealth, 949-812-6979