"We use companion diagnostics throughout clinical development to deliver innovative, targeted therapies to patients most likely to benefit," said Ruth March, VP and Head of Personalised Healthcare & Biomarkers at AstraZeneca. "The leading genomic profiling approach provided by Foundation Medicine can help ensure that patients are matched with therapies specifically targeted to the molecular drivers of their disease."
As part of the collaboration agreement, AstraZeneca will utilize the Quality Systems Regulations (QSR)-compliant version of Foundation Medicine's comprehensive genomic profiling assay for solid tumors to enroll patients into clinical trials of therapies that target genomically driven mechanisms of disease. The companion diagnostic assay assesses multiple cancer-related genes as well as all four classes of genomic alterations, and will be developed in parallel with the clinical development of AstraZeneca medicines as part of a coordinated regulatory strategy.
"We're delighted to expand our relationship with AstraZeneca to now include the development of companion diagnostics for their novel anti-cancer medicines," said Steven J. Kafka, Ph.D., President and Chief Operating Officer for Foundation Medicine. "This collaboration agreement, the fourth we have put in place with leading oncology companies, underscores the importance and potential of utilizing our rigorously validated, comprehensive profiling approach to make available to physicians an FDA-approved universal companion diagnostic solution for use with targeted medicines. We look forward to providing further updates as individual programs are initiated."