Qiagen NV announced the submission of its therascreen EGFR RGQ PCR Kit (therascreen EGFR test) to the U.S. Food and Drug Administration 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 who have with an epidermal growth factor receptor mutation detected by an FDA-approved test. The company has submitted a Premarket Approval 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. 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. 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. 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.