Date: 2015-12-08
Type of information: Commercialisation agreement
Compound: ConfirmMDx® for Prostate Cancer
Company: MDxHealth (Belgium) SouthGenetics (Uruguay)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: commercialisation
Action mechanism: diagnostic test. 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.
Disease: prostate cancer
Details: * On December 8, 2015, MDxHealth announced that it has partnered with SouthGenetics for the commercialization of its ConfirmMDx® for Prostate Cancer test in twelve countries across Central and South America. With this new partnership, SouthGenetics Inc., a Montevideo, Uruguay based biotechnology company that focuses on providing access to the latest medical diagnostic services, will have rights to commercialize ConfirmMDx within the following countries: Argentina, Bolivia, Chili, Columbia, Ecuador, Mexico, Peru, Dominican Rep., Panama, Paraguay, Uruguay, and Venezuela. In Latin America, more than 160,000 cases of prostate cancer are diagnosed every year and the issues associated with false-negative biopsies are a significant concern. All ConfirmMDx test orders generated through SouthGenetics' territories will be processed in MDxHealth's CLIA laboratory in Irvine, California.
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