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Agreements

Date: 2014-08-21

Type of information: Collaboration agreement

Compound: universal next-generation sequencing (NGS)-based oncology test system

Company: Illumina (USA - CA) AstraZeneca (UK) Janssen Biotech, a J&J company (USA - NJ) Sanofi (France)

Therapeutic area: Cancer - Oncology

Type agreement:

Action mechanism:

Disease: cancers

Details:

* On August 21, 2014, Illumina announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing (NGS)-based oncology test system. Under the collaboration, this system will be used to screen a panel of several gene sequences, scanning for all possible genetic variants — known and unknown — rather than specified mutations from a single tumour sample. The comprehensive information obtained from sequencing full genes will be used to predict which patients will respond to certain treatments, and will go through appropriate regulation. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca, Janssen Biotech and Sanofi. Illumina is working with these partners to develop assays that detect and measure multiple variants simultaneously to support partners\' clinical trials, with the objectives of securing regulatory agency approvals and test commercialization.

In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for \"companion therapeutics.\"

To date 125 known cancer driver genes have been discovered - 71 tumor suppressors and 54 oncogenes - that drive tumor growth through 12 cellular signaling pathways.1 While 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.

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