HILDEN, Germany, and GERMANTOWN, Maryland, July 6, 2012 /PRNewswire/ --
- U.S. launch of therascreen ® KRAS RGQ PCR Kit offers enhanced approach to guide treatments for approximately 110 ,000 patients annually in U.S. with colorectal cancer
- First FDA approval of a QIAGEN companion diagnostic marks a milestone in its global expansion of rapidly growing Personalized Healthcare business
- Important cancer assay adds valuable content for an expanding QIAGEN automation platform
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received U.S. Food and Drug Administration (FDA) approval to market the therascreen ® KRAS RGQ PCR Kit (therascreen KRAS test) to provide guidance on the use of Erbitux ® (cetuximab) as a treatment in patients with metastatic colorectal cancer.
The U.S. FDA approval of the KRAS test kit marks a milestone in QIAGEN's global expansion of its Personalized Healthcare franchise which includes an industry-leading portfolio of molecular companion diagnostics to aid treatment decisions in oncology. QIAGEN already markets a broad range of companion diagnostic tests covering 30 biomarkers in Europe, Asia/Pacific and Japan.
"We are very pleased to receive FDA approval to launch our therascreen KRAS test in the United States and to play a role in transforming the care of colorectal cancer patients. This approval marks an important step for QIAGEN, but also an important step in Personalized Healthcare, as we are now launching a major molecular companion diagnostic product in the U.S.," said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. "With a growing portfolio of innovative tests and efficient automation platforms, we are proud to be helping to make healthcare more effective, providing ways for payers to more efficiently use healthcare resources and, most important, making a positive impact on the care of patients."Pioneering role in Personalized Healthcare