Partners to Develop and Commercialize Noninvasive Tests for Bladder Cancer

MDxHealth has now signed an exclusive worldwide biomarker license and scientific collaboration agreement with the University Erasmus Medical Center granting MDxHealth exclusive worldwide rights for the use of a number of its bladder cancer DNA methylation biomarkers for both laboratory tests as well as in vitro diagnostic (IVD) products. University Erasmus Medical Center will receive upfront and milestone payments and royalties on net sales on any commercialized products. The two organizations have also agreed to collaborate in the clinical development of this and future bladder cancer tests.

Current diagnostic tools for the detection of bladder cancer are invasive and, with a sensitivity limited to only about 70%, leave many patients at risk of having undetected cancer. The MDxHealth liquid biopsy was designed to rule-out bladder cancer in patients with hematuria (blood in urine) noninvasively. It is based on DNA biomarkers that become modified by cancer cells. The liquid biopsy identifies these modifications at the genetic level providing the physicians with a tool to aid in the diagnosis of cancer, assess the risk of recurrence or metastasis of the cancer, and predict an individual patient’s likely response to cancer treatment.

Preliminary data from clinical trials conducted by the partners is due to be reported at the September 9–11, 2015, 11th World Congress on Urological Research that will be held in Nijmegen (The Netherlands). A cohort of 154 patients with hematuria, were tested, and it was found that the liquid biopsy urine test for bladder cancer had a negative predictive value (NPV) of 98.3%.

Dr. Jan Groen, CEO of MDxHealth, said, "Critical to our strategy is the discovery and development of noninvasive tests for urological disease. These positive data lead us to be confident that we could launch a urine based, “liquid biopsy” testing solution that will provide physicians a cost-effective, patient-friendly test to accurately aid bladder cancer detection and recurrence monitoring. We are delighted to be working alongside University Erasmus Medical Center and look forward to initiating a larger evaluation study in bladder cancer patients in due course.”

Dr. Ellen Zwarthoff, a professor at University Erasmus Medical Center, said, “Bladder cancer is the fifth most common cancer in the western world, and will continue to cost many lives unless we identify new approaches to diagnose it early, at its most treatable stages.”

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University Erasmus Medical Center