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QIAGEN builds on global collaboration with Amgen for companion diagnostic development in non-small cell lung cancerHilden, Germany and Germantown, Maryland, )
• QIAGEN to pursue global regulatory approvals, including Premarket Approval from FDA
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a strategic collaboration to develop tissue-based companion diagnostics for Amgen’s investigational cancer treatment AMG 510 to identify patients with cancers that have the KRAS G12C mutation. The agreement focuses initially on companion diagnostics for non-small cell lung cancer (NSCLC) but allows for further development of the tests for Amgen’s other oncology clinical development programs.
“We are pleased to support Amgen by building on the success of our therascreen platform to develop a tissue-based companion diagnostic to identify patients who would benefit from AMG510. QIAGEN’s Sample to Insight workflows and experience in developing diagnostic solutions for Precision Medicine are well-suited to help aid in evaluating patients with non-small cell lung cancer,” said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area. “The success of our long-standing collaboration with Amgen is a demonstration of QIAGEN’s capabilities as a preferred partner of pharmaceutical and biotech companies for the creation of companion diagnostics.”
“Amgen is committed to driving broad accessibility to biomarker testing in order to select appropriate patients who will directly benefit from targeted treatments,” said David M. Reese, M.D., Executive Vice President of Research and Development at Amgen. “With one in eight patients with NSCLC having KRAS G12C, there’s a critical need to improve access to high quality diagnostics and more routine screening.”
The therascreen-based companion diagnostic will screen for KRAS G12C, a genetic mutation that is one of the most common causes of cancer. The RAS gene family, studied for almost 40 years, includes the most frequently mutated oncogenes in human cancers 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. 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.
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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected net sales, net sales of particular products (including anticipated sales of its QuantiFERON latent TB Test, its portfolio of next generation sequencing solutions and QIAstat-Dx), adjusted net sales, adjusted diluted earnings per share results, product launches (including anticipated launches of digital PCR products, a new version of its QuantiFERON-TB test, QuantiFERON-TB Access, the QIAstat-Dx panel for respiratory conditions and a CE-IVD marked panel for meningitis), placements of QIAsymphony modular PCR instruments, improvements in operating and financial leverage, currency movements against the U.S. dollar, 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 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; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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).
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