MDxHealth SA, a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today 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.
"This partnership with Teva means that these important tests will now become available to cancer patients in Israel, our second market after the U.S.," said Dr. Jan Groen, CEO of MDxHealth. "We are delighted that Teva has agreed to invest its significant commercialization resources into our unique cancer products, expanding access to a new and diverse patient population."
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.
About ConfirmMDx® for Prostate Cancer
Over 975,000 American men are diagnosed with a negative prostate biopsy each year; however approximately 25-35% of those men receive false-negative results. Under the current standard of care, prostate biopsy procedures consisting of 10-12 needle biopsy cores only sample approximately 1% of a man's prostate. This approach leaves men at risk of occult cancer, leading to a high rate of repeat biopsies, often on cancer-free men. There is an unmet medical need for a clinically effective diagnostic test to address this dilemma. ConfirmMDx for Prostate Cancer is able to detect an epigenetic field effect or 'halo' associated with the cancerization process at the DNA level. This "halo" around a cancer lesion can be present despite cells having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying truly negative men who may forego an unnecessary repeat biopsy procedure.
About PredictMDx® for Glioblastoma
MDxHealth's PredictMDx for Glioblastoma (MGMT) test provides actionable information to oncologists seeking to provide personalized treatment of patients with brain cancer. The 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. Studies 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).
MDxHealth (mdxhealth.com) is a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment. The company's tests are based on proprietary gene methylation (epigenetics) technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy.
About Teva Pharmaceuticals
Teva Pharmaceuticals Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.
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This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
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