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GEN News Highlights : Jan 10, 2012

Qiagen Signs Two Biomarker Deals and Confirms Japanese Okay for EGFR Companion Dx

Qiagen gains rights to ALK biomarker and IDN1/IDH2 mutations for development of cancer tests.

Qiagen has signed separate deals with Insight Genetics, and with Personal Genome Diagnostics, which give the firm exclusive licenses to the cancer-related biomarkers ALK and IDH1/IDH2. The firm in addition confirmed that the Japanese regulatory authority has cleared its therascreen® EGFR Mutation Detection Kit RGQ for use in identifying non-small cell lung cancer (NSCLC) patients most likely to benefit from treatment with EGFR-inhibitor drugs. Qiagen’s theraScreen KRAS Mutation Detection Kit was approved in Japan in April last year.

The new biomarker deal with Insight Genetics takes the form of a strategic co-development partnership and licensing agreement for a genetic test covering the anaplastic lymphoma kinase (ALK) biomarker. Qiagen retains worldwide exclusive rights to its partner’s relevant diagnostic IP, and the firms will collaborate on developing a test that can be clinically validated and marketed by Qiagen as a companion diagnostic. The firm says ALK mutations are implicated in NSCLC and other cancers, and a number of ALK inhibitors are in clinical trials. However, it states, the one ALK inhibitor that is already FDA approved is used alongside a diagnostic method that is expensive and technically complicated.

The deal with Personal Genome Diagnostics, effected through Qiagen’s Ipsogen subsidiary, gives the firm exclusive rights to IDH1/IDH2 mutations, which Personal Genome Diagnostics claims are associated with brain cancers, acute myelogenous leukemia, and other cancers.

Qiagen says it will use the newly acquired IP to develop assays for research use and for the development of companion diagnostics.