QIAGEN’s KRAS Companion Diagnostic for Colorectal Cancer Adopted by Clarient

QIAGEN N.V. announced that Clarient 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 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.”
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The U.S. 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. For an updated list of U.S. laboratories now offering the therascreen KRAS test, please visit http://www.qiagen.com/mc/therascreenkrastest/patient/labfinder.aspx.

Approximately 110,000 metastatic colorectal cancer patients each year in the U.S. could benefit from KRAS testing, according to QIAGEN estimates. In patients for whom standalone surgery and chemotherapy are insufficient, treatment with an epidermal growth factor receptor (EGFR) inhibitor such as Erbitux has been shown to improve overall survival. However, determining the presence or absence of KRAS mutations in tumors affects outcomes. Approximately 60% of patients, whose tumors have mutation-negative (wild-type) KRAS genes, may benefit from anti-EGFR therapy. Approximately 40%, whose tumors have KRAS mutations, may not benefit.

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.

The U.S. healthcare system could save more than $600 million a year by determining KRAS status in colorectal cancer patients and avoiding unnecessary use of medicines, studies show.

QIAGEN is actively expanding its global portfolio of Personalized Healthcare technologies and intends to submit several companion diagnostics for U.S. 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 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. 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.