The launch of the therascreen KRAS RGQ PCR Kit, which provides guidance on the use of Erbitux ® (cetuximab) as a treatment in patients with metastatic colorectal cancer, has been gaining momentum following the U.S. regulatory approval of this product in July 2012. A number of top U.S. laboratories have already adopted QIAGEN's FDA-approved test, which in many cases has replaced use of their own laboratory-developed tests (LDTs). The transition of many more U.S. laboratories is expected in the coming months. Approval of the KRAS test was a milestone in QIAGEN's global expansion of its Personalized Healthcare franchise, as entry into the U.S. market builds on success in Europe, Japan and other markets where QIAGEN already offers a broad range of Personalized Healthcare tests.QIAGEN is actively expanding its pipeline in companion diagnostics and plans to submit several other tests for U.S. regulatory approval in the coming years. The next U.S. submission is planned for 2012 involving a therascreen EGFR assay as a companion diagnostic for use with Boehringer Ingelheim's investigational medicine afatinib in patients with non-small cell lung cancer (NSCLC).
QIAGEN Reports Third Quarter 2012 Results
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