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QIAGEN achieves Personalized Healthcare milestone with U.S. approval of companion diagnostic for colorectal cancer
11-07-2012: QIAGEN N.V. 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.
“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.”
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