Roche and Illumina partner to broaden patient access to genomic testing

Roche has announced that it has entered into a 15-year, non-exclusive partnership with Illumina to broaden the adoption of distributable next-generation sequencing (NGS) based testing in oncology. As the understanding of the genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment, and monitoring.

This agreement brings together the complementary capabilities of each company to broaden the global adoption of NGS in cancer care. As part of the agreement, Illumina will grant Roche rights to develop and distribute in vitro diagnostic (IVD) tests on Illumina's NextSeq™ 550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems. Roche will, in turn, collaborate with Illumina to complement Illumina's comprehensive pan-cancer assay TruSight Oncology 500 (TSO 500) with new companion diagnostic (CDx) claims. The financial terms of the deal were not disclosed.

Under the IVD terms of the agreement, Roche will develop, manufacture and commercialize AVENIO IVD tests for both tissue and blood for use on Illumina's NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Roche and Illumina will develop and pursue CDx claims on TSO 500 for both existing and pipeline Roche oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process and will continue to manufacture, supply and commercialize TSO 500. Roche will support the development of the claims and regulatory filings.

"As a leader in diagnostic innovation that helps save and improve lives, Roche is pleased to enter into a collaboration agreement with Illumina to leverage our combined expertise in clinical oncology and next-generation sequencing," said Thomas Schinecker, CEO of Roche Diagnostics. "This collaboration is uniquely positioned to improve medical value and clinical decision making globally by combining the unique capabilities of the Roche Group including Foundation Medicine with Illumina and will provide more patients with access to NGS to characterise their disease and identify the right treatment for them. This builds upon our strategy of accelerating clinical research, streamlining workflows and expanding assay menus to broaden access to genomic data and lower barriers to routine use."

• Partnership to leverage Illumina's extensive decentralized installed base with Roche's expertise in assay development and to provide broad access to clinical oncology next-generation sequencing
• Comprehensive genomic testing improves clinical decision making by genomically defining a patient's unique cancer and matching optimal treatment
• Collaboration agreement builds upon Roche's sequencing strategy to accelerate clinical research, streamline workflows and expand assay menus
• In addition, decentralized test expands the reach of Foundation Medicine platform for data and clinical decision support to help patients receive optimal cancer therapy

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