QIAGEN's therascreen EGFR Mutation Detection Kit receives Japanese regulatory approval

QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) today announced the regulatory approval of its therascreen^® EGFR Mutation Detection Kit RGQ in Japan. EGFR, the epidermal growth factor receptor, has been shown to play an important role in certain cancers and is the target of many new anticancer drugs.

The approval is a milestone in QIAGEN's Personalized Healthcare strategy, as Japan is one of the world's largest markets for companion diagnostic tests. In April 2011, QIAGEN's therascreen^® KRAS Mutation Detection Kit was approved in Japan, targeting a different biomarker that is also used to guide cancer treatment decisions. The potential patient population alone in Japan for EGFR and KRAS testing is estimated at approximately 100,000 per year.

"Greater use of companion diagnostic tests such as our EGFR and KRAS assays may help overcome significant challenges by maximizing the efficacy and safety of therapies and improving patient outcomes," said Dr. Stephen Little, Vice President Global Personalized Healthcare at QIAGEN. "Japanese and other East Asian populations generally have a higher rate of EGFR mutations than other groups, and non-smoking East Asian women are the largest potential market for EGFR-inhibitor anticancer drugs. This approval allows QIAGEN to market our companion diagnostic along with major pharmaceutical companies offering certain EGFR-inhibitor drugs. The approval of therascreen EGFR exemplifies our strategy of driving dissemination of molecular technologies by creating innovative test content and providing efficient, automated platforms for hospitals and laboratories to use these tests."

Companion diagnostic tests targeting EGFR, like QIAGEN's therascreen EGFR Mutation Detection Kit RGQ, determine the presence or absence of an EGFR mutation in a patient's tumor. Individuals, for whom treatment decisions are made following determination of EGFR mutation status, can experience 60% response rates to EGFR-inhibitor drugs, a much higher success rate than with traditional chemotherapy, studies show. Conversely, other patients can be unresponsive to EGFR-inhibitor drugs. Using the companion diagnostic not only may improve therapeutic outcomes, but also save patients and healthcare systems a significant amount of money since the newer classes of drugs can cost tens of thousands of dollars. By determining EGFR mutation status, doctors can prescribe the relevant drugs only to patients who are expected to benefit from them.