Illumina, a California-based developer, manufacturer and marketer of life science tools and integrated systems for the analysis of genetic variation and function, has formed collaborative partnerships with AstraZeneca, Janssen Biotech and Sanofi to develop a universal next-generation sequencing (NGS)-based oncology test system.
The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine.
Illumina is working with its strategic partners to develop assays that detect and measure multiple variants simultaneously to support its 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 partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for companion therapeutics.
“This partnership has the potential to deliver an unprecedented amount of clinical information from a single test,” said Ruth March, vice president, personalized healthcare and biomarkers at AstraZeneca. “Illumina’s technology will inform doctors about the molecular makeup of their patients’ tumors, enabling them to match medicines to the drivers of disease. Our aim is that doctors can use these tests to prescribe the right drugs to the right patients—bringing benefits to healthcare professionals, payers and patients alike.”
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. While 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.”