QIAGEN Achieves Milestone with U.S. Approval of Companion Diagnostic for Colorectal Cancer

QIAGEN N.V. has announced that 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.

Schatz continued, "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