Illumina Partners with Pharmaceutical Companies to Develop Companion Diagnostics

Illumina, Inc. (San Diego, CA, USA) has formed collaborative partnerships with pharmaceutical companies to develop a universal next-generation sequencing (NGS)-based oncology test system. Initial partners include AstraZeneca, Janssen Biotech, Inc., and Sanofi. The system will be used for clinical trials of targeted cancer therapies in order to develop and commercialize a multigene panel for therapeutic selection; this could result in a more comprehensive tool for precision medicine.

Illumina plans to develop assays that detect and measure multiple variants simultaneously, to support the partners’ clinical trials, with the aim of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working together with clinical experts to set standards for NGS-based assays in routine oncology practice, as well as to define regulatory frameworks to enable this new testing model. Together, Illumina and its partners aim to move from single-analyte companion diagnostics to panel-based assays that select for companion therapeutics.

Ellen V. Sigal, PhD, Chair and Founder of Friends of Cancer Research, commented, “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.”

To date 125 known cancer driver genes have been discovered, 71 tumor suppressors, and 54 oncogenes, which drive tumor growth through 12 cellular signaling pathways. 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.

Rick Klausner, MD, Illumina’s CMO, said, “Building on our experience with the MiSeqDx, the only US food and drug association (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 benefits to patients with cancer.”

Illumina develops, manufactures and commercializes life science tools and integrated systems for the analysis of genetic variation and function. The company provides sequencing and array-based solutions for genotyping, copy number variation analysis, methylation studies, gene expression profiling, and low-multiplex analysis of DNA, RNA, and protein.

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