Clarient - a GE Healthcare Company and a leading provider of cancer laboratory testing services in the United States - has adopted the use of Qiagen's 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 Qiagen's Rotor-Gene Q MDx instrument following the Food and Drug Administration (FDA) approval of the test in July 2012.

Clarient joins a rapidly growing number of laboratories switching from laboratory-developed tests (LDTs) to the FDA-approved therascreen KRAS test for diagnostic testing for late stage colorectal cancer.

"We are very pleased to partner with Clarient, a leading laboratory with a strong reputation among pathologists, oncologists and hospitals, to offer the therascreen KRAS test. Together, we will help bring our shared vision of the value of personalized healthcare to reality and transform outcomes by delivering personalized information to guide physicians and patients in the treatment of late-stage colorectal cancer," said Dr. Helge Lubenow, senior vice president, Molecular Diagnostics Business Area and member of the Executive Committee of Qiagen. "The future of Personalized Healthcare will be shaped by standardized tests like the therascreen KRAS test, backed by scientific rigor and regulatory review. Our growing portfolio of innovative diagnostics and efficient automation platforms is making healthcare more effective, saving money for payers and improving life for patients."

"We believe precision medicine is the new direction in diagnosing and treating cancer and Clarient uses state-of-the-art diagnostic technologies like the therascreen KRAS test to bring clarity and precision to physicians to assist them in making better treatment decisions for their patients," said Carrie Eglinton Manner, CEO, Clarient."Clarient's comprehensive offering and fast turnaround time coupled with our experience with the therascreen KRAS test permits us to provide a higher level of performance. Also, the fact that it is FDA approved provides Clarient with additional assurance of its quality and reliability."

The US launch of the therascreen KRAS test system including the Rotor-Gene Q MDx instrument, approved by the FDA in July 2012, is progressing well. To drive adoption, Qiagen supports partners like Clarient with co-marketing programs, reimbursement service, on-site validation and communication with pathologists and oncologists.

Qiagen's FDA-approved therascreen KRAS test offers a fast, consistent and reliable process to determine optimal treatment for colorectal cancer patients who are candidates for EGFR-inhibitor therapy. Qiagen's therascreen KRAS test has been shown to have a high sensitivity (low limit of detection) for KRAS mutations, a critical factor in ensuring high-quality data for treatment decisions.

Qiagen is actively expanding its global portfolio of Personalized Healthcare technologies and intends to submit several companion diagnostics for US regulatory approval. Earlier this month the Company announced submission of its therascreen EGFR RGQ PCR Kit to the FDA as a proposed companion diagnostic to guide treatment with afatinib, a new investigational oncology compound developed by Boehringer Ingelheim. More than 15 projects are under way to co-develop and market companion diagnostics with other leading pharmaceutical and biotech companies such as Amgen, AstraZeneca, Bayer and Pfizer.

The US 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. Qiagen currently markets therascreen assays in Europe for biomarkers including KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT and UGT1A1. In Japan, regulators approved the therascreen KRAS and EGFR kits in 2011, solidifying QIAGEN's leadership in that market. Qiagen also offers technologies for research use in the development of new medicines and companion diagnostics.

Qiagen NV, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information.