Illumina has entered cooperative alliances with major pharmaceutical firms for the development of a universal next-generation sequencing (NGS)-based oncology test system.
Leading to a more complete solution for precision medicine, the system will help in the clinical tests of targeted cancer therapies with a aim to develop and commercialize a multi-gene panel for therapeutic selection.
AstraZeneca , Janssen Biotech, Inc., and Sanofi are among the first strategic partners, with whom Illumina is working to create assays that detect and measure multiple variants at the same time to support partners' clinical tests, aiming to secure regulatory agency approvals and test commercialization.
The company is parallelly working with major thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as for the defining of regulatory frameworks to enable this new testing paradigm.
Illumina and its strategic partners jointly seek to move from single-analyte companion diagnostics to panel-based assays that select for "companion therapeutics."
Chair and Founder of Friends of Cancer Research, Ellen V. Sigal, Ph.D., said : "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. This is the type of collaboration that will make real progress for patients."
Ruth March, Vice President, Personalised Healthcare & Biomarkers at AstraZeneca, added, "This partnership has the potential to deliver an unprecedented amount of clinical information from a single test. Illumina s technology will inform doctors about the molecular make-up 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."
Rick Klausner, M.D., Illumina s Chief Medical Officer, stated : "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. 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 beneits to patients with cancer."