Life Technologies Corporation has signed an agreement to collaborate with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for current and future companion diagnostics projects. The non-exclusive agreement covers an initial project for oncology and provides for a long-term collaboration across a potentially broad range of instrument platforms and a wide range of therapeutic areas.
The collaboration will seek to combine the biomarkers identified by Merck’s translational research with Life Technologies’ proprietary platform technologies and to develop companion diagnostics concurrently with Merck’s drug development programs. It 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 span both genetic and proteomic analysis, including next-generation sequencing, Sanger sequencing, qPCR, and flow cytometry. Some have already received clearance by the Food and Drug Administration (FDA).
According to the 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 In 2011, the FDA released draft guidance addressing the use of companion diagnostics in clinical development and the review and approval process for diagnostics and associated new therapies. In addition the European Medicines Agency (EMA) has recently announced it is updating the guideline on evaluation of anticancer medicines to include companion diagnostics. Learn about molecular diagnostics solutions offered by Life Technologies.
