QIAGEN receives FDA approval to expand use of EGFR test in lung cancer
Extended labelling claim adds detection of three additional gene mutations to provide the most comprehensive mutation panel for GILOTRIF®
Germantown, Maryland, and Hilden, Germany, January 18, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN’s therascreen® EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer Ingelheim's targeted therapy GILOTRIF® (afatinib) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor (EGFR) mutations. The approval extends the labeling claim to include detection of EGFR mutations L861Q, G719X and S768I to aid the identification of NSCLC patients for whom GILOTRIF® (afatinib) is indicated. The therascreen® EGFR RGQ PCR Kit now detects the most comprehensive panel of EGFR mutations in which the safety and efficacy of GILOTRIF® (afatinib) have been established.
“As precision medicine develops increasing sophistication to guide the use of medicines based on individual genomic variations, we are pleased to provide benefits to more lung cancer patients with these additional biomarkers in our clinically proven therascreen® EGFR RGQ PCR Kit. Our collaboration with Boehringer Ingelheim, which led to FDA approvals of Gilotrif and our companion diagnostic in 2013, continues to improve personalized healthcare for patients around the world,” said Jonathan Arnold, Vice President and head of QIAGEN’s Partnering for Precision Diagnostics unit. “In addition to detecting the most comprehensive panel of EGFR mutations in which the safety and efficacy of GILOTRIF® (afatinib) have been established, the therascreen® EGFR RGQ PCR Kit offers laboratories an efficient workflow on the Rotor-Gene Q MDx, the real-time PCR module in our widely-used QIAsymphony family of instruments.”
QIAGEN is a pioneer in Personalized Healthcare and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect genetic abnormalities to provide insights that guide clinical decision-making on the use of drugs in diseases such as cancer. In 2017, QIAGEN announced that is working under master collaboration agreements with more than 25 pharmaceutical companies to develop companion diagnostic tests for their drug candidates. QIAGEN expects more than 5 FDA submissions and / or U.S. launches in 2018.
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 (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2017, QIAGEN employed approximately 4,600 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 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).