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Darmstadt, Germany, March 10, 2015 – Merck Serono, the biopharmaceutical business of Merck, and Illumina, Inc., today announced a collaboration to expand the development of a universal next-generation sequencing-based oncology diagnostic for clinical trials of targeted cancer therapies.
Under the terms of the agreement, Merck Serono and Illumina will work together to develop assays that detect and simultaneously measure multiple genetic variants in a single tumor sample in a clinical trial setting. Illumina’s successful regulatory track record was an important consideration in the collaboration, as next-generation sequencing platforms cleared by a regulatory agency could accelerate the development of an assay and facilitate the registration of a companion diagnostic.
“Our collaboration with Illumina around next-generation sequencing will enable us to perform genome studies at a pace unheard of a few years ago, and could lead to the development of several diagnostics,” said Susan Herbert, Head of Global Business Development at Merck Serono. “This collaboration will strengthen the position of Merck Serono as a global leader in precision medicine in oncology.”
The collaboration will include development of the diagnostic, worldwide regulatory approvals, and global commercialization.
“This agreement is another step forward in realizing the promise of precision medicine,” said Richard Klausner, M.D., Illumina’s Chief Medical Officer. “There is a clear need to expand genetically-based clinical trials as a key approach for developing better treatments for cancer. We are very excited to work with Merck Serono on this endeavor.”
This collaboration complements Merck Serono’s existing partnerships in the area of diagnostics, including Life Technologies and Dako, allowing Merck Serono to choose from a wide variety of technologies in implementing a precision medicine strategy.