Company’s portfolio already includes research-use kit for PI3K mutations.

Qiagen’s DxS subsidiary negotiated an exclusive global license to the Johns Hopkins University PI3K biomarker patent for use in the development of PCR-based companion diagnostics for cancer therapies.

“This license agreement is another step forward for Qiagen and for the use of novel therapeutics that rely on the widespread availability of the required PI3K companion diagnostic test,” comments Peer M. Schatz, CEO. “We are looking forward to developing drug-diagnostic combinations together with pharmaceutical partners for the selection of the right patient for the right medicine.”

Mutations in the PIK3CA oncogene have been observed in a number of cancers including breast, colon, lung, ovarian, liver, and stomach cancers, Qiagen states. The company already markets a PI3K test for research use, which detects four PI3K mutations in exons 9 and 20. The kit was launched at the end of 2008.

Qiagen acquired personalized medicines company DxS in September 2009. The deal included a $95 million cash payment up front and up to an additional $35 million dependent upon certain milestones. DxS specializes in the development molecular diagnostics to help select the most appropriate therapies for cancer patients.

Last week DxS announced an agreement with Pfizer to develop a test for the tumor-specific epidermal growth factor receptor variant III (EGFRvIII) as a companion diagnostic for CDX-110, Pfizer’s Phase II immunotherapy vaccine for the treatment of glioblastoma multiforme.

DxS’ existing product portfolio includes both clinical and research-use tests to determine the mutation status of cancer-related genes including K-RAS, B-RAF, and EGRF. The TheraScreen K-RAS test is CE-marked as companion diagnostic for determining the K-RAS oncogene mutation status of tumors prior to therapy with EGFR inhibitors including Vectibix® and Erbitux®. The TheraScreen EGFR29 Mutation Kit is CE-marked as a companion diagnostic to help select lung-cancer patients suitable for treatment with tyrosine kinase inhibitor therapies.

None of the tests have yet been approved by the FDA, although Qiagen states it plans to submit the K-RAS test to the agency in the near future. DxS has long-standing agreements with Amgen centered on the use or development of K-RAS mutation testing for use alongside its Vectibix cancer therapy.

In September 2009, the company signed a collaboration agreement with Bristol-Myers Squibb and ImClone Systems to provide a K-RAS companion diagnostic for use with Erbitux. In July of last year DxS confirmed a partnership with AstraZeneca to develop a companion diagnostic based on the TheraScreen EGFR29 mutation kit for use with lung-cancer drug Iressa.

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