llumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization.
In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for "companion therapeutics."
"The transition to patient-centered companion therapeutics marks a new era for oncology, and we are pleased to see pharmaceutical companies working with Illumina on a universal platform to bring life-saving treatments through their development pipelines," said Ellen V. Sigal, Ph.D., Chair and Founder of Friends of Cancer Research. "This is the type of collaboration that will make real progress for patients."
To date 125 known cancer driver genes have been discovered – 71 tumor suppressors and 54 oncogenes – that drive tumor growth through 12 cellular signaling pathways.1 While today the number of available targeted therapies is limited, an estimated 800 oncology drugs are in development, many of which are designed to target specific mutations. With the emergence of new targeted therapies, there is growing need for new companion diagnostic tests.
"Building on our experience with the MiSeqDx, the only FDA-cleared NGS platform, as well as the additional regulatory expertise we gained with the acquisition of Myraqa, Illumina is developing the universal test system to support our partners’ oncology drug pipelines," said Rick Klausner, M.D., Illumina’s Chief Medical Officer. "These agreements represent the deep engagement between Illumina and the pharma community to create the technical, clinical, regulatory and ultimately commercial solutions for the next generation of molecular oncology. We’re excited to be working together to maximize benefits to patients with cancer."