Illumina and QIAGEN Announce 15-Year Strategic Partnership to Co-Develop NGS-Based IVD Kits for Global Clinical Diagnostics

Strategic Partnership to Accelerate Next-Generation Sequencing (NGS)

Steps in Applying to Clinical Decision-Making

SAN DIEGO, Hilden, Germany, and Germantown, Maryland—PR Newswire—Illumina, Inc. (NASDAQ:ILMN) and QIAGEN (New York Stock Exchange ticker symbol:QGEN) (Stock Code on the Prime Standard of the Frankfurt Stock Exchange:QIAGEN) today announced the establishment of a 15-year partnership to expand the application of NGS-based IVD test kits in patient management, including companion diagnostics.

This agreement grants QIAGEN non-exclusive rights to develop and commercialize IVD kits for Illumina’s MiSeq™ Dx and NextSeq™ 550Dx systems in the global market.The agreement also grants QIAGEN the right to expand its collaboration on Illumina’s future clinical diagnostic (Dx) systems.The two parties also seek opportunities for QIAGEN to collaborate in the future development and promotion of Illumina-based TruSight Oncology (TSO) assays, which enable comprehensive genomic profiling of tumor samples in immunotherapy.

Illumina and QIAGEN will further collaborate to bring to market a suite of clinically validated analytical workflows that integrate QIAGEN’s proprietary content with bioinformatics solutions.This collaboration will initially focus on bringing tumor-related IVD kits to market to support patient management. In the future, the partnership will expand into additional clinical diagnostic areas, such as cardiology, genetic disorders, infectious diseases, and inflammatory and autoimmune diseases.

Illumina CEO Francis deSouza stated:“We are committed to expanding the number of clinical use cases addressed through genomic sequencing, enabling partners to offer IVD tests and companion diagnostics on Illumina’s Dx instruments.”Our collaboration with QIAGEN will expand the test menu options for Illumina’s TSO 500 series, thereby accelerating the adoption of NGS in the management of cancer patients.”

“Our strong partnership marks an important milestone, underscoring our shared vision to drive the adoption of NGS technology in clinical decision-making and to leverage this powerful technology to improve clinical outcomes for patients worldwide,” said Peer M. Schatz, CEO of QIAGEN.“QIAGEN is delighted with this groundbreaking partnership and hopes that it will leverage our unique strengths to evolve into a long-term and productive collaboration.”This partnership represents a key step in our NGS strategy, which will continue to encompass universal solutions compatible with any sequencer, as well as the GeneReader NGS System, primarily suited for smaller targeted gene panels.Through this partnership, we expect to create significant value for our customers and both parties, and to maximize QIAGEN’s opportunities to deliver value as a company by providing solutions spanning from sample preparation to data interpretation.”

  Strategic Partnership 

Through this collaboration, QIAGEN is committed to leveraging its market-leading companion diagnostic capabilities and integrated solutions spanning sample preparation to data interpretation to build a more diverse IVD test menu on Illumina’s Dx sequencing platforms, thereby enhancing both companies’ channel coverage and market position in the IVD sector.

QIAGEN is a global leader in molecular (PCR and NGS) precision medicine, having entered into more than 25 comprehensive collaboration agreements with pharmaceutical and biotechnology companies to co-develop companion diagnostic products and obtain regulatory approvals.To date, seven therapies have received FDA approval in combination with QIAGEN companion diagnostic assays.

Leveraging the global market share of the MiSeqDx and NextSeq 550Dx platforms, Illumina boasts a robust diagnostic NGS portfolio capable of covering a range of clinical applications designed for diverse clinical laboratory settings.As NGS testing begins to play a more significant role in patient care, Illumina is committed to providing clinical solutions—developed both in-house and in collaboration with partners—to support the diagnosis and management of human diseases.

About Illumina

Illumina, Inc. improves human health by decoding genomes.We prioritize innovation, which has established us as a global leader in DNA sequencing and microarray technologies, serving customers across the research, clinical, and applied markets.Our products are applied in life sciences, oncology, reproductive health, agriculture, and other emerging markets.For more information, please visit www.illumina.com or follow @illumina.

About QIAGEN

QIAGEN N.V. is a holding company headquartered in the Netherlands and a global leader in providing solutions from sample preparation to data interpretation. Our solutions enable customers to obtain valuable molecular insights from samples containing the building blocks of life.Our sample technology enables the isolation and processing of DNA, RNA, and proteins from blood, tissue, and other materials.Our analytical technologies convert these biomolecules into visualizable data for analysis.Bioinformatics software and knowledge bases can interpret data and report relevant, actionable insights.Automation solutions can integrate these steps into a seamless and cost-effective workflow.QIAGEN provides solutions to more than 500,000 users worldwide in the fields of molecular diagnostics (human healthcare) and life sciences (academia, pharmaceutical R&D, and industrial applications, primarily in forensics).As of June 30, 2019, QIAGEN employed approximately 5,200 employees across more than 35 locations worldwide.For more information, please visit:http://www.qiagen.com

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.Any statements in this article relating to QIAGEN and Illumina products, launches, regulatory opinions, collaborations, markets, strategies, taxation, or operating results (including but not limited to their expected net sales, net sales of specific products, adjusted net sales, adjusted diluted earnings per share, product launches, improvements in operational and financial leverage, foreign exchange rate fluctuations, and investment plans for portfolio and stock repurchase commitments) are forward-looking. Such statements are based on current expectations and assumptions and involve certain uncertainties and risks.Such uncertainties and risks include, but are not limited to:Risks Associated with Growth and International Business Management (Including the Impact of Currency Fluctuations, Regulatory Processes, and Dependence on Logistics);Variability of operational results and their allocation among various customers;Business development for product markets targeting customers in academia, the pharmaceutical industry, applied testing, molecular diagnostics, and related fields;Changes in relationships with customers, suppliers, and strategic partners;Competition;Rapid or unexpected technological changes;Fluctuations in demand for QIAGEN and Illumina products (including those caused by general economic conditions, customer funding levels and timing, budgets, and other factors);The ability to obtain regulatory approval for products;Challenges in seamlessly adapting products to integrated solutions and in manufacturing such products;The ability to identify and develop new products, as well as to differentiate products and protect them from competitive pressures;Market acceptance of new products and the integration of acquired technologies and businesses;as well as other factors discussed under the heading “Risk Factors” in Item 3 of QIAGEN’s latest Annual Report on Form 20-F, and in Item 1A of Illumina’s latest Quarterly Report on Form 10-Q and Annual Report on Form 10-K.For more information, please refer to the discussions in the reports filed by or submitted to the U.S. Securities and Exchange Commission (SEC) by QIAGEN and ILLUMINA, respectively.

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