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Qiagen Gains Approval in Japan for EGFR Companion Dx, Acquires Rights to New Markers

NEW YORK (GenomeWeb News)– Qiagen today announced that Japanese regulators have approved the company's Therascreen EGFR Mutation Detection Kit as a companion diagnostic for drugs targeting non-small cell lung cancer.

Separately, it also said that it has acquired the rights to biomarkers from two US firms for applications in personalized treatment of various cancers.

Qiagen's PCR-based EGFR assay determines the presence or absence of an EGFR mutation in a patient's tumor to help guide treatment with EGFR inhibitors. Qiagen cited studies demonstrating that patients who are tested for EGFR mutation status can experience 60 percent response rates to such therapies, a "much higher" response rate than with chemotherapy.

In addition, use of a companion diagnostic may lead to savings in healthcare costs, the company said.

In Japan and East Asia, a test for EGFR mutations could be especially meaningful because populations in the region have a higher rate of EGFR mutations in general, Qiagen said. Non-smoking women in East Asia represent the largest potential market for EGFR-inhibitor oncology drugs, the company added.

The approval means Qiagen will be able to market its kit in Japan with drug firms that offer certain EGFR inhibitors.

The company said that Japan is one of the world's largest markets for companion diagnostic tests. In April, regulators there approved the Therascreen KRAS Mutation Detection Kit. The total Japanese patient population for EGFR/KRAS mutation testing is estimated at 100,000 per year, Qiagen said.

New Biomarkers

The company also said that it has entered into a worldwide co-development and licensing deal with Insight Genetics, and that its 89 percent subsidiary Ipsogen has reached a deal with Personal Genetics.

The agreement with Insight, based in Nashville, Tenn., is for intellectual property related to the anaplastic lymphoma kinase biomarker, a promising target for a new class of drugs for lung cancer. The Ipsogen-Personal Genetics deal, meantime, provides Qiagen the worldwide exclusive rights to diagnostics for mutations in the IDH1 and IDH2 genes, which may be associated with brain cancers, acute myelogenous leukemia, and certain other malignancies.

Qiagen said that it plans to collaborate with Insight to develop a test using the ALK biomarker that can be clinically validated and marketed by Qiagen as a companion diagnostic.

ALK mutations are associated with NSCLC and other cancers and several ALK inhibitors are in clinical trials. While one ALK inhibitor – Xalkori, co-developed by Abbott and Pfizer – has been approved by the US Food and Drug Administration, "it is currently paired with a diagnostic method that can be technically challenging and costly," Qiagen said.

FDA approved Xalkori in August along with Abbott's Vysis ALK Break Apart FISH Probe as a companion diagnostic.

Of its deal with Baltimore, Md.-based Personal Genetics, the company said that assays that detect and measure IDH1/IDH2 mutations could provide important insights into disease research and differential diagnosis, and have value in the development of companion diagnostics.

Financial and other terms of the licensing deals were not disclosed.

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