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Life Technologies to Collaborate with Merck Serono for Companion Diagnostics Development and Commercialization
Date:7/16/2013

tional research with Life Technologies' proprietary platform technologies and to develop companion diagnostics concurrently with Merck's drug development programs. The collaboration will also work to simultaneously seek regulatory approval of Merck's drug and Life Technologies' companion diagnostic. Life Technologies offers a variety of platform technologies that support the development of new diagnostics. These technologies span both genetic and proteomic analysis, including next-generation sequencing, Sanger sequencing, qPCR and flow cytometry, some of which have already received clearance by the Food and Drug Administration (FDA). If successful, the agreement will be followed by a commercialization agreement under which Life Technologies will commercialize the companion diagnostic in agreed upon territories.

"Life Technologies is uniquely positioned to provide pharma a flexible, cost effective means to manage the evolution of the of companion diagnostic assays through the drug development process," said Andrews.

According to FDA, a companion diagnostic is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapy. In 2011, the FDA released draft guidance addressing the use of companion diagnostics in clinical development and the review and approval process for diagnostics and associated new therapies.1 In addition the European Medicines Agency (EMA) has recently announced it is updating the guideline on evaluation of anticancer medicines to include companion diagnostics.2

References
1. Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices, Issued July 14, 2011. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm262292.
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