SAN DIEGO--(BUSINESS WIRE)--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.
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to each of Roche’s and Illumina’s products, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation their expected net sales, net sales of particular products, product launches, improvements in operating and financial leverage, currency movements, and plans for investment in their respective portfolios, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics); variability of operating results and allocations between customer classes; the commercial development of markets for products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for each of Roche’s and Illumina’s products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); ability to obtain regulatory approval of products; difficulties in successfully adapting products to integrated solutions and producing such products; the ability to identify and develop new products and to differentiate and protect products from competitors' products; market acceptance of new products and the integration of acquired technologies and businesses; and the other factors discussed under the heading “Risk Factors” contained in Illumina’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K. For further information, please refer to the discussions in reports that Illumina has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).