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QIAGEN’s KRAS Companion Diagnostic for Colorectal Cancer Adopted by Clarient, a Leading U.S. Oncology Service Lab

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) recently 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.

Source: Qiagen

GE Healthcare Licenses Genomic Biomarker for Lung Cancer from Insight Genetics

Clarient Diagnostic Services, Inc., a GE Healthcare company, and molecular diagnostics company Insight Genetics, Inc., today announced a worldwide licensing agreement for intellectual property from Insight Genetics, granting Clarient rights to develop a genetic test covering the ALK (anaplastic lymphoma kinase) biomarker, a promising target for several classes of cancer drugs.

GE Healthcare Completes Acquisition of SeqWright, Inc., Expanding Capabilities in Fast Growing Molecular Siagnostic Segment

GE Healthcare, a unit of GE (NYSE: GE) announced today that it has acquired SeqWright, Inc., a provider of nucleic acid sequencing and other genomic services. The acquisition adds complementary genomics capabilities to Clarient, a unit of GE Healthcare and a leader in the fast-growing molecular diagnostics sector. The deal also provides a platform for Clarient to expand its clinical diagnostic offerings to include next generation sequencing. Financial terms of the acquisition were not disclosed.

Clarient and ACORN Research Announce a Collaboration to Standardize Testing of Most Common Cancers

Clarient, Inc., a GE Healthcare company, and ACORN Research LLC announced earlier this week their strategic collaboration around molecular testing of tumor samples. The agreement will establish a standardized testing protocol across the ACORN network of oncology community practices and hospitals with treatment guidelines and clinical trial opportunities. These processes have the potential to improve oncology treatment and research that aim to deliver targeted treatments based on the specific genetic markers for each patient.

Clarient Joins the HistoRX Clinical Trials Network

Clarient, a GE Healthcare company, and HistoRx, Inc., have signed a definitive agreement to provide pharma services using AQUA technology to their growing lists of pharma clients. By implementing HistoRx’s AQUA technology in Clarient’s CLIA laboratory, the two companies will apply their complementary capabilities to serve pharma companies’ growing need for biomarker analysis in clinical trials. Use of tissue biomarkers to characterize a patient’s tumor is becoming a crucial element of personalized cancer care. AQUA technology is an automated, quantitative IHC testing method that enables standardized precision measurement of protein biomarkers in tissue as an aid to a pathologist’s diagnosis.