QIAGEN receives FDA approval of therascreen® KRAS RGQ PCR Kit paired with second colorectal cancer drug
Clinically proven companion diagnostic gains U.S. approval to guide use of Amgen’s Vectibix® (panitumumab) in treatment of metastatic colorectal cancer
FDA approval (PMA) of therascreen KRAS RGQ PCR Kit for Vectibix expands QIAGEN’s leadership in molecular companion diagnostics for personalized healthcare
QIAGEN driving the adoption of molecular tests to guide patient treatment decisions with expanding content menu on the QIAsymphony automation platform portfolio
GERMANTOWN, Maryland, and HILDEN, Germany, May 23, 2014 — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that its therascreen® KRAS RGQ PCR Kit (therascreen KRAS test) has received U.S. Food and Drug Administration (FDA) approval to guide the treatment of metastatic colorectal cancer patients with Amgen’s Vectibix® (panitumumab). This marks the third FDA approval of a companion diagnostic from QIAGEN that has been paired with a novel medicine.
QIAGEN’s growing menu of clinically validated companion diagnostics is driving global dissemination of personalized healthcare, which uses genomic information to guide treatment decisions in individual patients.
“The U.S. approval of our therascreen KRAS test with Amgen’s EGFR inhibitor, Vectibix, marks a further milestone for QIAGEN’s global growth in companion diagnostics for personalized healthcare. Our global portfolio covers more than 25 molecular tests targeting various companion diagnostic biomarkers. The performance and ease of use of QIAGEN’s tests are now increasingly driving dissemination of personalized healthcare in the U.S. and countries around the world,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “Our success in this long-standing collaboration with Amgen is a further demonstration of QIAGEN’s capabilities as a preferred partner of pharmaceutical and biotech companies for co-development and commercialization of companion diagnostics. The continuing rollout of standardized, regulatory-approved tests also is adding valuable content for our Rotor-Gene Q MDx, a real-time PCR platform in our revolutionary QIAsymphony family.”
Personalized Healthcare is a strategic growth driver for QIAGEN. In addition to the latest U.S. approval of therascreen KRAS paired with Vectibix and the 2012 approval with Erbitux, QIAGEN’s therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) was approved by the FDA in 2013 to guide the use of GILOTRIF™ (afatinib) for treatment of metastatic non-small cell lung cancer (NSCLC). In 2014, QIAGEN has launched its therascreen® IDH1/2 RGQ Kit in Europe to guide the management of patients with gliomas (tumors of the brain) and received approval in China for the therascreen EGFR test in NSCLC, the company’s first companion diagnostic in China. QIAGEN already markets therascreen assays in Europe for biomarkers including KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT, UGT1A1 and many others. In Japan, the second largest market for Personalized Healthcare, therascreen KRAS and EGFR kits were launched in 2011.
KRAS mutations, occurring in approximately 40% of colorectal cancer patients, influence response to anti-EGFR therapies such as Vectibix and Erbitux. Screening colorectal cancer patients with therascreen KRAS detects the most frequent mutations in the KRAS gene and helps to guide treatment planning.
QIAGEN is expanding its pipeline of biomarkers and technologies to address the continuously evolving needs of personalized healthcare, including the RAS gene family. QIAGEN is co-developing the industry’s widest range of companion diagnostics under more than 20 project agreements with pharmaceutical and biotech companies, including five master collaboration agreements.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of March 31, 2014, QIAGEN employed approximately 4,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
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, new product developments, new product launches, regulatory submissions, and financing plans 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).