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QIAGEN achieves Personalized Healthcare milestone with U.S. approval of companion diagnostic for colorectal cancerHilden, Germany and Germantown, Maryland, )
- U.S. launch of therascreen® KRAS RGQ PCR Kit offers enhanced approach to guide treatments for approximately 110,000 patients annually in U.S. with colorectal cancer
- First FDA approval of a QIAGEN companion diagnostic marks a milestone in its global expansion of rapidly growing Personalized Healthcare business
- Important cancer assay adds valuable content for an expanding QIAGEN automation platform
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received U.S. Food and Drug Administration (FDA) approval to market the therascreen® KRAS RGQ PCR Kit (therascreen KRAS test) to provide guidance on the use of Erbitux® (cetuximab) as a treatment in patients with metastatic colorectal cancer.
The U.S. FDA approval of the KRAS test kit marks a milestone in QIAGEN’s global expansion of its Personalized Healthcare franchise which includes an industry-leading portfolio of molecular companion diagnostics to aid treatment decisions in oncology. QIAGEN already markets a broad range of companion diagnostic tests covering 30 biomarkers in Europe, Asia/Pacific and Japan.
“We are very pleased to receive FDA approval to launch our therascreen KRAS test in the United States and to play a role in transforming the care of colorectal cancer patients. This approval marks an important step for QIAGEN, but also an important step in Personalized Healthcare, as we are now launching a major molecular companion diagnostic product in the U.S.,” said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. “With a growing portfolio of innovative tests and efficient automation platforms, we are proud to be helping to make healthcare more effective, providing ways for payers to more efficiently use healthcare resources and, most important, making a positive impact on the care of patients.”
Pioneering role in Personalized Healthcare
QIAGEN is at the forefront of developing and validating a range of tests that provide physicians with an individual patient’s molecular information to select the most appropriate medicines.
The entry into the U.S. market with the approval of the first therascreen test builds on our success in the European market, where QIAGEN offers 10 CE-marked assays, based either 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, the therascreen KRAS and EGFR kits were approved in 2011, solidifying QIAGEN’s leadership position for companion diagnostics in the second biggest market for Personalized Healthcare. A range of assays and related Sample & Assay Technologies are also marketed to customers use during the research and development of new medicines.
QIAGEN is actively expanding its pipeline of Personalized Healthcare technologies and intends to submit several companion diagnostics in the coming years for U.S. regulatory approval. QIAGEN has more than 15 projects under way to co-develop and market companion diagnostics with leading pharmaceutical and biotech companies such as Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, and Pfizer.
Benefiting patients and providers
Introduction of the therascreen KRAS test provides an FDA-approved diagnostic available for making treatment decisions for colorectal cancer patients. Approximately 110,000 colorectal cancer patients each year in the U.S. could benefit from KRAS testing, according to QIAGEN estimates.
Studies show the U.S. healthcare system could save more than $600 million annually by avoiding unnecessary use of medicines in colorectal cancer patients through determinations of their KRAS status. In metastatic colorectal cancer patients for whom standalone surgery and chemotherapy are insufficient, treatment with an epidermal growth factor receptor (EGFR) inhibitor has been shown to improve overall survival. However, the presence or absence of KRAS mutations in tumors affects outcomes: Approximately 60% of patients with mutation-negative (wild-type) KRAS genes may benefit from anti-EGFR therapy, while 40% whose tumors have KRAS mutations may not benefit.
The first FDA approval of the therascreen KRAS test pairs this companion diagnostic with Erbitux®, a leading EGFR inhibitor marketed in the U.S. by Bristol-Myers Squibb in partnership with Eli Lilly and its ImClone Systems unit. According to the U.S. product information for Erbitux®, KRAS status evaluation using an FDA-approved diagnostic test is used to determine treatment, and the therascreen KRAS kit is currently the only test with this status. Based on the FDA approval for use in metastatic colorectal cancer patients, the current annual U.S. market potential for sales of the therascreen KRAS kit in this indication only is approximately $20 million.
In contrast to laboratory-developed tests (LDTs), the FDA-approved therascreen KRAS test gives healthcare providers a fast, consistent and reliable process to determine optimal treatment for colorectal cancer patients who are candidates for EGFR-inhibitor therapy. The therascreen KRAS kit has been shown to have higher sensitivity (i.e. a lower limit of detection, LOD) for KRAS mutations between 0.8% and 6.4% depending on the assay which is critical to ensuring reliable and consistent data for treatment decisions.
Following FDA approval, a number of laboratories will begin offering KRAS status evaluation with the therascreen KRAS test:
- Applied Diagnostics, Inc.
- Boyce & Bynum Pathology Laboratories
- Cellnetix Pathology & Laboratories
- Clinical Molecular Oncology Laboratory, The University of Kansas Medical Center
- Colorado Molecular Correlates Laboratory (CMOCO), University of Colorado
- Companion Dx Reference Lab, LLC
- Dahl-Chase Diagnostic Services
- Lab21 Inc.
- Mayo Clinic
For more details and actual status visit www.qiagen.com/therascreen
Adding value to QIAGEN’s automation platforms
In line with QIAGEN’s strategy of driving platform success, the therascreen KRAS test offers laboratories an efficient workflow based on the Rotor-Gene Q MDx, an automated molecular detection instrument that uses real-time PCR technology. All other companion diagnostics in development, as well as a range of other molecular diagnostic tests, are being developed for U.S. regulatory approval on the Rotor-Gene Q MDx.
The therascreen KRAS kit is the second assay cleared/approved by the FDA for use on the Rotor-Gene Q MDx. Earlier in 2012, QIAGEN’s artus Infl A/B RG RT-PCR for the detection of Influenza A/B was cleared for use on Rotor-Gene Q MDx, with the instrument also receiving FDA 510(k) clearance at the same time.
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 are forward-looking, such statements are based on current expectations 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 and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's, products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, 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 its 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, 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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