SAN DIEGO—Illumina Inc. has struck several collaborative partnerships—teaming up with AstraZeneca, Janssen Biotech Inc. and Sanofi—in order to develop a universal next-generation sequencing (NGS)-based oncology test system. This system would be utilized for clinical trials of targeted cancer therapies in hopes of developing and commercializing a multi-gene panel for therapeutic selection and enabling more comprehensive personalized medicine.
“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,” Dr. Rick Klausner, chief medical officer of Illumina, said in a press release. “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.”
Illumina will work with its partners to develop assays that can detect and measure multiple variants at once in order to support clinical trials. In conjunction with this effort, Illumina is also speaking with key thought leaders in hopes of establishing standards for NGS-based assays in routine clinical oncology practice and defining the regulatory frameworks for such a paradigm. The goal of these collaborations is to advance the field from single-analyte companion diagnostics to panel-based assays that can 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,” Dr. Ellen V. Sigal, chair and founder of Friends of Cancer Research, commented in a statement. “This is the type of collaboration that will make real progress for patients.”
“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,” said Ruth March, vice president of Personalized Healthcare & Biomarkers at AstraZeneca.
Just last month, Illumina posted news of another partnership based on its NGS technology; on July 21, Berry Genomics Co. Ltd. announced that it had selected Illumina’s NGS technology as the platform on which it would seek Chinese Food and Drug Administration regulatory approval for clinical applications. Per the agreement, Illumina and Berry Genomics co-developed an NGS system to provide a cost-effective, easy-to-use assay for non-invasive prenatal testing.