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Agreements

Date: 2014-01-23

Type of information: Commercialisation agreement

Compound: ConfirmMDx®, PredictMDx®

Company: MDxHealth (Belgium) Teva Pharmaceuticals (Israel)

Therapeutic area: Diagnostic - Cancer - Oncology

Type agreement:

commercialisation

Action mechanism:

ConfirmMDx for Prostate Cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and, helps rule in high risk patients who may require repeat biopsies and potential treatment. The test is able to detect an epigenetic field effect or \"halo\" associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular \"halo\" around a cancer lesion can be present despite having a normal appearance under the microscope. PredictMDx for Glioblastoma (MGMT) test assesses the methylation status of the MGMT gene, which is crucial to promoting DNA repair. If the MGMT gene is methylated, cancer patients have shown improved response to alkylating drug therapy. tudies on thousands of patients have shown that PredictMDx for Glioblastoma can help identify patients that are likely to respond to the most commonly used class of brain cancer drugs (alkylating agents).

Disease: prostate cancer, glioblastoma

Details:

* On January 23, 2014, MDxHealth, a belgian molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, has announced that it has signed an exclusive agreement with Teva Pharmaceuticals Ltd. for commercialization of ConfirmMDx® for Prostate Cancer and PredictMDx® for Glioblastoma tests in Israel. ConfirmMDx provides physicians with actionable information that helps improve patient care, particularly the avoidance of unnecessary repeat prostate biopsies. The PredictMDx test is used to identify glioma patients who have methylation of the MGMT (O6-Methylguanine-DNA Methyltransferase) gene. In clinical studies, these patients have shown the potential to respond better to certain chemotherapeutic drugs.
Under the terms of this three-years agreement, Teva Pharmaceuticals Industries will be the exclusive distributor of both tests in Israel. Samples will be sent to MDxHealth\'s CLIA-registered laboratory in Irvine, California for analysis. Teva will reimburse MDxHealth for all the testing services.

Financial terms:

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Is general: Yes