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QIAGEN Achieves Personalized Healthcare Milestone with U.S. Approval of Companion Diagnostic for Colorectal Cancer
Date:7/6/2012

to QIAGEN estimates.

Studies show the U.S. healthcare system could save more than $600 million annually by avoiding unnecessary use of medicines in colorectal cancer patients through determinations of their KRAS status. In metastatic colorectal cancer patients for whom standalone surgery and chemotherapy are insufficient, treatment with an epidermal growth factor receptor (EGFR) inhibitor has been shown to improve overall survival. However, the presence or absence of KRAS mutations in tumors affects outcomes: Approximately 60% of patients with mutation-negative (wild-type) KRAS genes may benefit from anti-EGFR therapy, while 40% whose tumors have KRAS mutations may not benefit.

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.

In contrast to laboratory-developed tests (LDTs), the FDA-approved therascreen KRAS test gives healthcare providers a fast, consistent and reliable process to determine optimal treatment for colorectal cancer patients who are candidates for EGFR-inhibitor therapy. The therascreen KRAS kit has been shown to have higher sensitivity (i.e. a lower limit of detection, LOD) for KRAS mutations between 0.8% and 6.4% depending on the assay which is critical to ensuring reliable and consistent data for treatment decisions.  

Following FDA approval, a numbe
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SOURCE QIAGEN N.V.
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