Illumina and QIAGEN Partner to Deliver Sequencing-Based In-Vitro Diagnostic (IVD) Tests

Illumina, Inc. (NASDAQ: ILMN) and QIAGEN N.V. (NYSE: QGEN) (Frankfurt Prime Standard: QIA) today announced a 15-year partnership intended to broaden the availability and use of NGS-based IVD kits, including companion diagnostics, for patient management.

The agreement grants QIAGEN non-exclusive rights to develop and globally commercialize IVD kits to be used together with Illumina’s MiSeq™ Dx and NextSeq™ 550Dx Systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic (Dx) systems. Both partners are also exploring opportunities for QIAGEN to develop and market companion diagnostics based on Illumina’s TruSight Oncology (TSO) assays that enable comprehensive genomic profiling of tumor samples in immunotherapy.

Illumina and QIAGEN will cooperate to commercialize a menu of clinically validated workflows that combine QIAGEN’s proprietary content and bioinformatics solutions. The partnership will initially focus on commercializing oncology IVD kits to support patient management and may expand in the future to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, as well as inflammatory and autoimmune diseases.

“We are committed to expanding the range of clinical use cases addressed by genomic sequencing by enabling partners to deliver IVD tests and companion diagnostics on Illumina’s Dx instruments,” said Francis deSouza, Chief Executive Officer of Illumina. “Our partnership with QIAGEN will complement Illumina’s TSO 500 family with additional testing menu options, accelerating NGS adoption in oncology patient management.”

“Bringing together our highly complementary capabilities marks an important milestone to advance the use of NGS technologies in clinical decision-making and our shared vision of using this powerful technology to improve the outcomes for patients worldwide,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “We at QIAGEN are very pleased with this ground-breaking partnership and this first step in what we hope to be a long and productive relationship that capitalizes on combining our unique strengths. This partnership becomes a key cornerstone of our NGS strategy, which continues to include our universal solutions for use with any sequencer as well as the GeneReader NGS System for use primarily with smaller, targeted gene panels. Through this partnership, we look forward to creating significant benefits for customers and for both parties, as well as to allowing QIAGEN to maximize our opportunities as a company creating value by offering sample-to-insight solutions.”

Bringing Together Highly Complementary Capabilities

Through this partnership, QIAGEN endeavors to build a broad menu of IVD tests on Illumina’s Dx sequencers by leveraging its market leading companion diagnostic capabilities and Sample to Insight solutions, thereby enhancing both companies’ channel reach and presence in the IVD market.

QIAGEN is an established global leader in molecular (PCR and NGS-driven) precision medicine given its portfolio of more than 25 master collaboration agreements with pharmaceutical and biotechnology companies to co-develop and gain regulatory approvals for companion diagnostics. So far, seven therapies have received FDA co-approval with a QIAGEN companion diagnostic assay.

With global availability of the MiSeq Dx and NextSeq 550Dx platforms, Illumina has a robust diagnostic NGS product portfolio capable of covering a broad range of clinical applications designed for a variety of clinical lab settings. As NGS testing begins to play a more significant role in patient care, Illumina is committed to providing clinical solutions, both Illumina developed and partner driven, that support the diagnosis and management of human diseases.

About Illumina

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.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2019, QIAGEN employed approximately 5,200 people in over 35 locations worldwide. Further information can be found at 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 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 QIAGEN's and ILLUMINA’s products, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected net sales, net sales of particular products, adjusted net sales, adjusted diluted earnings per share results, product launches, improvements in operating and financial leverage, currency movements, and plans for investment in its portfolio and share repurchase commitments, 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 our 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 QIAGEN'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 our 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 Item 3 of QIAGEN’s most recent Annual Report on Form 20-F and Item 1A of 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 each of QIAGEN and ILLUMINA has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

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