QIAGEN Submits Companion Diagnostic to FDA to Guide Treatment Decisions for New Investigational Lung Cancer Compound
HILDEN, Germany and GERMANTOWN, Maryland, January 15, 2013 /PRNewswire/ --
- U.S. submission of therascreen® EGFR RGQ PCR Kit is paired with FDA submission of afatinib, an investigational tyrosine kinase inhibitor developed by Boehringer Ingelheim
- Companion diagnostic intended to aid treatment decisions in non-small cell lung cancer
- QIAGEN continues to expand Personalized Healthcare portfolio and content menu for modules of the QIAsymphony automation platform
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced submission of its therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) to the U.S. Food and Drug Administration (FDA) as a proposed companion diagnostic to guide treatment with afatinib, a new investigational oncology compound developed by Boehringer Ingelheim. Afatinib has been accepted for filing and granted Priority Review by the FDA as a proposed treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who havewith an epidermal growth factor receptor (EGFR) mutation detected by an FDA-approved test.
QIAGEN submitted a Premarket Approval (PMA) application for use of the therascreen EGFR test to determine which NSCLC patients would be potentially eligible for treatment with afatinib. The companion diagnostic was developed in collaboration with Boehringer Ingelheim. In September 2012, the proposed drug also has been submitted to the European Medicines Agency (EMA). A version of the therascreen EGFR test has already been CE-marked and is available for diagnostic use in Europe. In late 2011, the test has also received regulatory approval in Japan, the world's second largest market for Personalized Healthcare.
Lung cancer is the deadliest form of cancer. More than 200,000 new lung cancer cases in the United States and 391,000 in Europe are diagnosed each year, leading to an estimated 160,000 deaths in the U.S. and 340,000 in Europe. NSCLC accounts for about 85% of all lung cancer cases. Tumors in 10% to 15% of Caucasians and about 40% of Asians with NCSLC have mutations involving EGFR, a protein found on the surface of cells. EGFR mutations can lead to its constant activation (or over-expression), which is associated with uncontrolled cell division and development of advanced NSCLC. Clinical studies on treatment with afatinib for EGFR mutation-positive patients, as identified by the therascreen EGFR test, have shown improvement in progression free survival and tumor shrinkage compared with standard chemotherapy. The submission of the afatinib registration is supported by the findings of Boehringer Ingelheim's LUX-Lung 3 study, the largest Phase III trial conducted to date in untreated patients with locally advanced or metastatic NSCLC with a confirmed EGFR mutation-positive status, using the therascreen EGFR test.
"When approved, the therascreen EGFR test will enable doctors to make informed treatment decisions for many cancer patients. Submission of therascreen EGFR test, which runs on Rotor-Gene Q, is another milestone for our Personalized Healthcare franchise," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "We continue to advance our strategic initiative to add new test content by seeking regulatory approval for diagnostic kits to run on modules of the QIAsymphony family. The therascreen EGFR test will add to QIAGEN's menu of other therascreen assays including the therascreen® KRAS RGQ PCR Kit launched last year in the U.S. The breadth and quality of this menu will create significant value for laboratories, oncologists, patients and payers seeking the best outcomes by leveraging the potential of Personalized Healthcare."
Dr. Helge Lubenow, Senior Vice President, Molecular Diagnostics Business Area and member of the Executive Committee of QIAGEN, added: "The success of our collaboration with Boehringer Ingelheim in developing the therascreen EGFR test with afatinib exemplifies our strategy of partnering with leading pharmaceutical and biotech companies to commercialize companion diagnostics. We are uniquely committed to supporting the emergence of Personalized Healthcare, and QIAGEN's pipeline of innovative technologies and biomarkers is positioned to fuel growth in in this field for years to come."
QIAGEN markets in Europe additional therascreen assays for biomarkers including NRAS, BRAF, PI3K, JAK2, MGMT and UGT1A1. A range of biomarker assays and related Sample & Assay Technologies also are marketed to customers globally for use during the research and development of new medicines.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of September 30, 2012, QIAGEN employed approximately 4,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Certain of the statements contained in this news 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, markets, strategy or operating results, including without limitation its expected operating 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 in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based 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, the consummation of acquisitions, 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).
Dr. Thomas Theuringer
Director Public Relations
VP Corporate Communications
Director, Global Investor Relations
SOURCE Qiagen N.V.