QIAGEN Partners With Mirati Therapeutics Inc. to Develop KRASG12C Companion Diagnostic for Non-Small Cell Lung Cancer (NSCLC)

• KRAS mutations in NSCLC reflect a large underserved patient population with an unmet need for innovative treatment options
• QIAGEN is developing a tissue-based companion diagnosticin support of adagrasib, Mirati’s investigational selective KRAS^G12C inhibitor
• Program adds to QIAGEN's strong position in KRAS companion diagnostic testing in NSCLC

QIAGEN N.V. (NYSE:QGEN; Frankfurt Prime Standard:QIA) today announced a global collaboration with Mirati Therapeutics Inc. (NASDAQ:MRTX) to continue developing a tissue-based KRAS companion diagnostic to identify patients with cancers that have a KRAS^G12C mutation who may benefit from treatment with adagrasib, Mirati’s investigational, highly selective and potent oral small molecule inhibitor of KRAS^G12C.

The agreement initially focuses on a companion diagnostic test for non-small cell lung cancer (NSCLC), and allows for further development of tests for other Mirati oncology programs.

The planned companion diagnostic would expand upon QIAGEN’s therascreen KRAS testing portfolio based on real-time qualitative PCR for the QIAGEN Rotor-Gene Q MDx instrument, a member of the modular QIAsymphony family of automation solutions, and builds upon the Company’s nearly decade of experience in KRAS companion diagnostic test development and commercialization. QIAGEN and Mirati have previously partnered for the development of a companion diagnostic.

“We are pleased Mirati recognizes the success of QIAGEN’s therascreen platform and continues to partner with us to develop a tissue-based companion diagnostic to identify patients who may benefit from adagrasib. QIAGEN’s experience and expertise in developing diagnostic solutions for Precision Medicine are well-suited to evaluate patients with non-small cell lung cancer,” said Jean-Pascal Viola, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “Our collaboration with Mirati is a demonstration of QIAGEN’s capabilities as a preferred partner of pharmaceutical and biotech companies for the creation of companion diagnostics.”

The therascreen-based companion diagnostic detects KRAS^G12C, a genetic mutation that is one of the most common KRAS alterations linked to cancer. The RAS gene family is the most frequently mutated oncogene in human cancer, with KRAS being the most prevalent driver mutation in NSCLC.

QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. QIAGEN has nine PCR based companion diagnostics that are FDA approved, including therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients. QIAGEN is partnering with Illumina to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management.

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), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of March 31, 2020, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

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 products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, 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 products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

Category: Corporate

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