QIAGEN NV has received US 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 FDA approval of the KRAS test kit marks a milestone in QIAGEN’s global expansion of its personalized health care 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.

The entry into the US market with the approval of the first therascreen test builds on the company’s success in the European market, where QIAGEN offers 10 CE-marked assays, based either on real-time PCR technology or on Pyrosequencing. QIAGEN currently markets therascreen assays in Europe for biomarkers including KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT, and UGT1A1. In Japan, the therascreen KRAS and EGFR kits were approved in 2011, solidifying QIAGEN’s leadership position for companion diagnostics in the second biggest market for personalized health care. A range of assays and related Sample & Assay Technologies are also marketed to customers use during the research and development of new medicines.

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 US 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 US by Bristol-Myers Squibb in partnership with Eli Lilly and its ImClone Systems unit. According to the US 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 US market potential for sales of the therascreen KRAS kit in this indication only is approximately $20 million.

Source: QIAGEN