France-based company bioMerieux, a world leader in the field of in vitro diagnostics for over 45 years and a provider of diagnostic solutions (reagents, instruments, software) designed to determine the source of disease and contamination to improve patient health and ensure consumer safety, has signed an agreement with GlaxoSmithKline (GSK) to develop a predictive test to help clinicians select the most appropriate treatment for different segments of breast cancer patients.This diagnostic test, which helps clinicians make the right therapeutic decision for the right patients enabling a more personalized approach to medicine is based on emerging biomarkers, is, subject to regulatory approvals, intended for use in both adjuvant and metastatic breast cancer settings. Over 500,000 new cases of breast cancer are diagnosed each year in the US and Europe alone and predictive tests have been shown to improve outcomes for these patients.”This new collaboration is a significant milestone in our theranostics strategy,” said Stephane Bancel, bioMerieux Chief Executive Officer. “Working with GSK, we hope to achieve an important breakthrough in breast cancer care, helping oncologists to determine the most appropriate treatment as early as possible to give a significant number of breast cancer patients the chance for a better outcome.”The development of this new test will be co-funded by both companies and will leverage their complementary expertise. GSK, a world leader in oncology therapeutics, will bring its extensive experience in the field of cancer and conducting clinical studies and will also facilitate access to samples from several clinical trials under the collaboration.The new test will be developed by bioMerieux’s global R&D team, including its subsidiary, bioTheranostics, which has a high complexity laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). The bioTheranostics team has expertise in molecular oncology diagnostics, with its THEROS CancerTYPE ID? test for identifying metastatic cancers of uncertain or unknown origin and THEROS Breast Cancer Index(SM) test for predicting breast cancer recurrence risk.Following clinical evaluation, the test will be launched by bioTheranostics in its CLIA-certified laboratory, after which an in vitro diagnostic kit will be developed by bioMerieux and introduced to the global market leveraging the resources of bioMerieux and the collaboration.

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