Date: 2015-08-18
Type of information: Licensing agreement
Compound: bladder cancer DNA methylation biomarkers for both laboratory developed tests as well as in vitro diagnostic (IVD) products
Company: MDxHealth (Belgium) University Erasmus Medical Center (Belgium)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: licensing
Action mechanism: The test is based on a combination of MDxHealth and University Erasmus Medical Center (\'Erasmus MC\') bladder cancer DNA methylation biomarkers. The Company has now signed an exclusive worldwide biomarker license and scientific collaboration agreement with Erasmus MC granting MDxHealth exclusive worldwide rights for the use of a number of its bladder cancer DNA methylation biomarkers for both laboratory developed tests as well as in vitro diagnostic (IVD) products.
Disease: bladder cancer
Details: * On August 18, 2015, MDxHealth announced positive top-line data for the Company\'s liquid biopsy test for bladder cancer. The Company\'s urine-based bladder cancer test is designed to rule-out bladder cancer in patients with hematuria (blood in urine) non-invasively. Current diagnostic tools are invasive and, with a sensitivity limited to 70%, leave many patients at risk of having undetected cancer. However, preliminary data due to be reported at the 11th World Congress on Urological Research (Nijmegen, The Netherlands, 9-11 September 2015), in a cohort of 154 patients with hematuria, has shown that the Company\'s epigenetic \"liquid biopsy\" urine test for bladder cancer had a negative predictive value (NPV) of 98.3%. The test is based on a combination of MDxHealth and University Erasmus Medical Center (Erasmus MC) bladder cancer DNA methylation biomarkers. MDxHealth has now signed an exclusive worldwide biomarker license and scientific collaboration agreement with Erasmus MC granting MDxHealth exclusive worldwide rights for the use of a number of its bladder cancer DNA methylation biomarkers for both laboratory developed tests as well as in vitro diagnostic (IVD) products.
Financial terms: Erasmus MC will receive upfront and milestone payments, and royalties on net sales on any commercialized products. Erasmus MC and MDxHealth have also agreed to collaborate in the clinical development of this and future bladder cancer tests, building on Erasmus MC\'s extensive research into biomarkers for bladder cancer and MDxHealth\'s market leading DNA methylation-based molecular diagnostics technologies and strong focus in urologic oncology.
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