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Illumina to Develop NGS-based Oncology Companion Dx with AstraZeneca, Janssen Biotech, Sanofi

NEW YORK (GenomeWeb) — Illumina has partnered with AstraZeneca, Janssen Biotech, and Sanofi to develop a universal next-generation sequencing-based oncology test system for multi-analyte companion diagnostics, the company said today.

The goal of the partnership is to transition from single-analyte companion diagnostics to panel-based assays to select cancer therapies for patients.

The new system, which will run assays that detect several variants in parallel, will be used as part of the partners' clinical trials of targeted cancer therapies. Illumina plans to develop, commercialize, and gain regulatory approval for multi-gene panels for therapy selection, which it previously referred to as Onco Panels.

Illumina also said it is working with "key thought leaders" to set standards for NGS-based assays in routine clinical oncology and to define regulatory frameworks for these types of tests.

According to Rick Klausner, Illumina's chief medical officer, the company will build on its experience with the MiSeqDx, the only NGS-based system that has been FDA-cleared to date, and on regulatory expertise from Myraqa, which Illumina aquired last month, to develop the universal test system. "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," he said in a company statement.

"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," Ruth March, vice president of personalised healthcare and biomarkers at AstraZeneca, added in the statement.

The new partnerships follow an agreement between Illumina and Amgen earlier this year to develop an NGS-based companion diagnostic on the MiSeqDx system for the colorectal cancer drug Vectibix.

According to Illumina, about 800 oncology drugs, many of which target specific mutations, are currently in development, resulting in a growing need for new companion diagnostics.