Qiagen 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."

In other news, Qiagen announced two agreements with U.S. biotech companies to acquire worldwide exclusive rights to biomarkers that are expected to play an important role in personalized treatment of various cancers.

Qiagen has entered into a strategic co-development partnership and licensing agreement with Insight Genetics Inc. (Nashville, TN) for a genetic test covering the ALK (anaplastic lymphoma kinase) biomarker, a promising target for a novel class of lung cancer drugs.

Through a separate agreement between its 89% subsidiary Ipsogen and Personal Genome Diagnostics Inc. (Baltimore, MD), Qiagen has also acquired worldwide exclusive rights to testing for mutations of the IDH1 and IDH2 genes, which are believed to play a role in brain cancers, acute myelogenous leukemia (AML) and certain other malignancies.

"These two new agreements add to our significant activities in further expanding our broad portfolio of novel and relevant biomarkers that can drive personalized healthcare. Qiagen is a global leader in the emerging market for companion diagnostics, which are increasingly guiding the treatment decisions in various cancers and other diseases," said Peer Schatz, Chief Executive Officer of Qiagen. "The two agreements add to our portfolio the ALK biomarker, which is being targeted by several pharmaceutical companies for new anti-cancer treatments, as well as the IDH1/IDH2 biomarker, which is currently playing a critical role in intense R&D activity for candidate medicines targeting brain gliomas and other cancers. In addition to providing these assays to researchers, we intend to develop companion diagnostics to make these biomarkers available in combination with new medicines."

The strategic co-development partnership and licensing agreement with Insight Genetics gives Qiagen worldwide exclusive rights to Insight Genetics' diagnostic IP to the ALK gene. The companies will collaborate in the development of a corresponding test that can be clinically validated and marketed by Qiagen as a companion diagnostic. Mutations of ALK are implicated in non-small cell lung cancer (NSCLC) and other cancers, and several anticancer compounds known as ALK inhibitors, are in clinical trials. One ALK inhibitor has been approved by FDA, but it is currently paired with a diagnostic method that can be technically challenging and costly.

-Richard Park