Illumina announces collaborative partnership to develop oncology companion diagnostics

Illumina Inc. announced it has formed collaborative partnerships with AstraZeneca, Janssen Biotech Inc. and Sanofi to develop a universal next-generation sequencing-based oncology test system.

The novel system is intended for clinical trials of targeted cancer therapies with the objective of developing a multi-gene panel for therapeutic selection, which could provide a more comprehensive tool for precision medicine.

“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,” Ellen V. Sigal, PhD, chair and founder of Friends of Cancer Research said in a press release. “This is the type of collaboration that will make real progress for patients.”

Illumina has partnered with pharmaceutical companies to develop assays that detect and assess multiple variants concurrently to support partners’ clinical trials, with the goal of securing regulatory agency approvals and test commercialization.

Illumina is also collaborating with key opinion leaders to set standards for next-generation sequencing-based assays in routine clinical oncology practice, in addition to defining regulatory frameworks to enable this new testing paradigm.

Illumina and its partners intend to transition from single-analyte companion diagnostics to panel-based assays that select for 'companion therapeutics.' At present, there are 125 known cancer driver genes, including 71 tumor suppressors and 54 oncogenes that promote tumor growth through 12 cellular signaling pathways. While there are a limited number of available targeted therapies, there are approximately 800 oncology drugs currently in development, several of which are designed to target specific genetic mutations.

“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,” Rick Klausner, MD, CEO of Illumina, said in the 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.”