QIAGEN Submits Companion Diagnostic to FDA
News Jan 22, 2013
QIAGEN N.V. 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) with 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. 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 this field for years to come.”