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QIAGEN Receives FDA Approval of therascreen KRAS RGQ PCR Kit Paired with Second Colorectal Cancer Drug

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

Source: Qiagen