Signs worldwide exclusive agreement with Erasmus MC for bladder cancer DNA methylation markers
Full data to be presented at 11th World Congress on Urological Research
IRVINE, CA, and HERSTAL, BELGIUM, August 18, 2015 – MDxHealth SA (Euronext: MDXH), announced today 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. 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.
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.
Dr Jan Groen, Chief Executive Officer of MDxHealth, commented, “Critical to our strategy is the discovery and development of non-invasive 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 Erasmus MC and look forward to initiating a larger evaluation study in bladder cancer patients in due course.”
Prof. Dr. Ellen Zwarthoff, from the Erasmus MC Cancer Institute, added, “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.
“Our collaboration with MDxHealth, a recognized player in the urologic oncology diagnostic space, can bring the biomarkers developed by Erasmus MC and MDxHealth towards patient care.”
About Bladder Cancer
In the US and EU, over 170,000 patients are diagnosed with bladder cancer every year, and over 50,000 patients will die from the disease. Annually in the US alone, it is estimated that over 1 million patients with hematuria (blood in urine) are referred to urologists for fear of bladder cancer. The traditional tools and procedures employed for the detection of bladder cancer have some limitations, not the least of which are cost and invasiveness, but also these methodologies are prone to miss some small bladder tumors, satellite lesions as well as carcinoma in situ. Importantly, bladder cancer is one of the most expensive cancers to treat given more than half of all early stage bladder cancer patients will recur in the three years following treatment.
About Erasmus MC
Erasmus MC is the largest and most authoritative University Medical Center in the Netherlands. Almost 13,000 staff members work within the core tasks of patient care, education, and scientific research on the continuous improvement and enhancement of individual patient care and social healthcare. They develop high-level knowledge, pass this on to future professionals, and apply it in everyday patient care.
MDxHealth is a multinational healthcare company that provides actionable epigenetic information to personalize the diagnosis and treatment of cancer. The company’s tests are based on proprietary gene methylation (epigenetic) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
| For more information:
Dr. Jan Groen, CEO
US: +1 949 812 6979
BE: +32 4 364 20 70
Mike Sinclair (PR)
UK: +44 20 7318 2955
Cell: +44 7968 022075
Amber Fennell (IR)
UK: +44 20 3709 5701
Cell: + 44 7739658783
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