QIAGEN Announces FDA Approval of Companion Diagnostic Colorectal Cancer Test

QIAGEN has announced that 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.

Introduction of the therascreen KRAS test provides an FDA-approved diagnostic available for making treatment decisions for colorectal cancer patients. Approximately 110,000 colorectal cancer patients each year in the U.S. could benefit from KRAS testing, according to QIAGEN estimates.

The first FDA approval of the therascreen KRAS test pairs this companion diagnostic with Erbitux^®, a leading EGFR inhibitor marketed in the U.S by Bristol-Myers Squibb in partnership with Eli Lilly and its ImClone Systems unit. According to the U.S. product information for Erbitux^®, KRAS status evaluation using an FDA-approved diagnostic test is used to determine treatment, and the therascreen KRAS kit is currently the only test with this status. Based on the FDA approval for use in metastatic colorectal cancer patients, the current annual U.S. market potential for sales of the therascreen KRAS kit in this indication only is approximately $20 million.

“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.