QIAGEN receives FDA approval to expand use of EGFR test in lung cancer
Sep 28 2018

QIAGEN receives FDA approval to expand use of EGFR test in lung cancer

Approval allows use of therascreen® EGFR RGQ PCR Kit as a companion diagnostic for Pfizer’s VIZIMPRO® (dacomitinib) in patients with non-small cell lung cancer

Germantown, Maryland, and Hilden, Germany, September 28, 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 expanding the labelling claim of the therascreen® EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO® (dacomitinib) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 L858R mutation. The therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also GILOTRIF® (Afatinib) from Boehringer Ingelheim and Iressa® (Gefitinib) from AstraZeneca. It is registered in more than 40 countries globally. This was a project governed under an agreement between QIAGEN and Pfizer.


“As precision medicine becomes the standard of care in oncology, we are pleased to provide benefits to more lung cancer patients with our clinically proven therascreen EGFR RGQ PCR Kit. Our collaboration with Pfizer has made great strides already and will
continue to improve personalized healthcare for patients around the world,” said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics for QIAGEN. “In addition to detecting a comprehensive panel of EGFR mutations, the therascreen EGFR 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.”

“VIZIMPRO is an important new treatment option for first-line therapy for patients with EGFR-mutated non-small cell lung cancer exon 19 deletion or exon 21 L858R substitution mutations” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “The FDA’s expanded approval of the therascreen EGFR kit which was used in the pivotal clinical trial for VIZIMPRO, will enable physicians to identify patients who may benefit from this medicine. Pfizer and QIAGEN have long collaborated in the co-development of companion diagnostics for precision medicines in oncology, and this result shows the value of this ongoing collaboration.”

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. QIAGEN has an unmatched depth and breadth of technologies from NGS to PCR for companion diagnostic development. In 2018, 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. For more details surrounding QIAGEN’s companion diagnostics and their claims please visit
www.qiagen.com. For additional information on Pfizer’s VIZIMPRO® (dacomitinib) please visit www.pfizer.com.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer deaths worldwide, and non-small cell lung cancer (NSCLC) accounts for an estimated 80-85 percent of cases. NSCLC remains difficult to treat, particularly because many patients are diagnosed with advanced or metastatic disease, where the five-year survival rate is only five percent. Mutations in the EGFR gene, generally somatic changes that develop during a patient’s lifetime rather than through inheritance, are implicated in an estimated 10-35 percent of NSCLC cases globally. Cancers with these mutations tend to respond to treatments that specifically target the overactive EGFR protein that causes cancer cells to constantly grow and divide.

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 June 30, 2018, QIAGEN employed approximately 4,800 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).

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