Illumina, Inc. (NASDAQ: ILMN), the global leader in DNA sequencing and array-based technologies, and Roche, a global pioneer in pharmaceuticals and diagnostics, today announced a 15-year, non-exclusive collaboration agreement to broaden the adoption of distributable next-generation sequencing-based (NGS) testing in oncology. As the understanding of genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring.
This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As part of this 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, including the forthcoming NovaSeqDx. 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, Illumina and Roche will develop tests and pursue CDx claims on TSO 500 for both existing and pipeline 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.
“We are excited Roche has selected Illumina’s sequencers as their platform of choice to accelerate the adoption and broaden the reach of oncology-based, distributable IVD tests into clinical care,” said Francis deSouza, CEO of Illumina. “This partnership complements and strengthens our strategy to establish TSO 500 as a comprehensive NGS panel for cancer therapies by expanding the supported set of CDx claims on this universal panel. Building on the momentum of other recently established diagnostic and pharmaceutical partnerships, together we aim to advance critical access to NGS testing to improve patient outcomes.”
Illumina’s TSO 500 is a comprehensive pan-cancer assay designed to identify known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key somatic variants underlying tumor progression, such as small DNA variants, fusions and splice variants. When used to test for companion diagnostics claims, TSO 500 is poised to identify cancer patients globally who might benefit from targeted therapeutics. As the anchor tenant of Illumina’s oncology product portfolio, TSO 500 enables labs to adopt a comprehensive genomic profiling panel, in a decentralized testing model, leveraging the accurate and reproducible results of Illumina’s diagnostic sequencing systems.