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Qiagen, Eli Lilly Ink Companion Dx Deal for JAK2 Inhibitor

NEW YORK (GenomeWeb News) – Qiagen today announced a deal with Eli Lilly to develop a companion diagnostic for an investigational compound the drug manufacturer is developing for blood cancers.

The deal calls for Qiagen to develop, manufacture, and co-commercialize a test for Eli Lilly's JAK2 inhibitor, which targets the Janus kinase 2, or JAK2, gene, which is associated with myeloproliferative neoplasms, a variety of blood cancers that cause abnormal growth in blood cells.

The JAK2 pathway is "considered to bring high value to drug development in terms of defining and directing the right therapies for patients, and therefore represents a very important target of R&D initiatives in the pharmaceutical industry," Qiagen said in a statement.

Qiagen gained access to the JAK2 biomarker though an agreement with Ipsogen, which Qiagen is in the process of acquiring.

The company will develop a companion diagnostic test that provides qualitative and quantitative results for JAK2 V617F. The test is for identifying patients most likely to benefit from treatment with inhibitors of the pathway, Qiagen said, and added that today's deal includes development and use of Qiagen's JAK2 assay during clinical trials and manufacturing and joint commercialization of the test in parallel with Eli Lilly's compound.

Additional financial terms were not disclosed.

JAK2 V617F testing is currently available through clinical laboratories as a laboratory-developed test.

Qiagen will exclusively market its test, which will be PCR-based and will run on the Rotor-Gene Q instrument. The company also plans to seek regulatory approval for full automation of the workflow on the QIASymphony RGQ sample-to-result platform that Qiagen launched last year.

Qiagen noted that it has partnerships with more than 15 drug firms to co-develop companion diagnostics, including a deal announced last month with Pfizer covering a test for non-small cell lung cancer.

Also in August, Qiagen submitted a second premarket approval application to the US Food and Drug Administration for its KRAS RGQ PCR kit for use as a companion diagnostic with metastatic colorectal cancer drug Erbitux (cetuximab), sold in the US by Eli Lilly and Bristol-Myers Squibb.

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