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QIAGEN's KRAS companion diagnostic for colorectal cancer adopted by Clarient, a leading U.S. oncology service lab
- Momentum builds for therascreen® KRAS RGQ PCR Kit and Rotor-Gene Q MDx instrument
- Clarient offers network of 2,000-plus pathologists testing with therascreen KRAS RGQ PCR Kit, the only FDA-approved KRAS companion diagnostic for Erbitux® in metastatic colorectal cancer
- KRAS launch prepares way for QIAGEN's growing pipeline of Personalized Healthcare content
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that Clarient - a GE Healthcare Company and leading 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 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 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.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
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