Date: 2017-03-21
Type of information: Distribution agreement
Compound: SelectMDx™ for Prostate Cancer test
Company: MDxHealth (Belgium) Lab21 (UK), part of the Novacyt Group (France)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: distribution
Action mechanism: biomarker/diagnostic test. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive 'liquid biopsy' method to assess a man's risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce unnecessary MRI procedures and invasive prostate biopsies by approximately 50%, thereby reducing healthcare costs. The novel biomarkers that make up SelectMDx were discovered by Prof. 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.
Disease: prostate cancer
Details: * On March 21, 2017, MDxHealth announced that it has signed a distribution agreement to make its SelectMDx™ for Prostate Cancer test available to Lab21 Clinical Laboratory's urology clients in the UK. Under the terms of the agreement, Lab21 will serve as a non exclusive distributor for SelectMDx in the UK. Liquid biopsy samples will be tested in MDxHealth's state-of-the-art clinical diagnostic laboratory in Nijmegen, The Netherlands. Lab21 will reimburse MDxHealth for all testing services performed.
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