Qiagen N.V. announced that Clarient, a GE Healthcare Company and provider of cancer laboratory testing services in the United States, has adopted the use of the Therascreen KRAS RGQ PCR Kit (Therascreen KRAS test) as a companion diagnostic to guide the use of Erbitux (cetuximab) as a treatment in patients with metastatic colorectal cancer. Clarient, with a customer base of more than 2,000 pathologists, oncologists, clinical laboratories, and hospitals, selected Qiagen’s Therascreen KRAS test and Rotor-Gene Q MDx instrument following FDA's approval of the test in July 2012.
The U.S. launch of the Therascreen KRAS test system, including the Rotor-Gene Q MDx instrument, is progressing well, Qiagen reports. To drive adoption, Qiagen supports partners such as Clarient who offer co-marketing programs, reimbursement service, on-site validation, and communication with pathologists and oncologists. The company makes available on its website an updated list of U.S. laboratories offering the Therascreen KRAS test.
Approximately 110,000 metastatic colorectal cancer patients each year in the U.S. could benefit from KRAS testing, according to Qiagen estimates.
The U.S. rollout of the Therascreen KRAS test builds on success in Europe, where Qiagen offers 10 CE-marked assays based on real-time PCR technology or on pyrosequencing. The company currently markets Therascreen assays in Europe for biomarkers including KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT, and UGT1A1.