Qiagen, the leading global provider of sample and assay technologies announced that it has entered into a partnership with Eli Lilly and Company for the development, manufacturing and commercialization of a molecular companion diagnostic for an early stage investigational compound currently being developed by Lilly. Financial terms of the agreement were not disclosed.
Lilly's proprietary compound, called a JAK2 inhibitor, targets the Janus kinase 2 (JAK2) gene, which has been shown to play a role in myeloproliferative neoplasms, a variety of blood cancers that cause blood cells to grow abnormally.
Under the terms of the agreement, Qiagen will develop a new companion diagnostic test that will provide both qualitative and quantitative results for JAK2 V617F. The assay is intended to identify patients most likely to benefit from treatment with inhibitors of the pathway. The scope of the partnership includes development and use of the Qiagen JAK2 assay during clinical trials and also covers manufacturing and joint commercialization of the diagnostic product in parallel with the Lilly compound.
Qiagen gained exclusive access to the JAK2 biomarker through an agreement with Ipsogen, a French company that is a pioneer in profiling and biomarkers for leukaemia and other blood cancers. In June, Qiagen announced a proposal to fully acquire Ipsogen through a process that is under way. 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.
“The collaboration with Lilly is a strong testament to Qiagen's capabilities in companion diagnostics, biomarkers and personalized healthcare,” commented Dr Stephen Little, vice president Personalized Healthcare at Qiagen. “We look forward to developing the potential for this innovative diagnostic-therapeutic combination to improve the standard of care for patients suffering from these blood cancers.”
Qiagen currently offers about 20 tests for use in Personalized Healthcare and has partnerships under way with more than 15 pharma companies to co-develop companion diagnostics.
JAK2 V617F testing is currently being offered by clinical labs in the form of lab-developed tests (LDTs). The new PCR-based companion diagnostic will be exclusively marketed by Qiagen and will run on Qiagen's Rotor-Gene Q instrument. Qiagen also intends to seek regulatory approval for full automation of the workflow on the QIAsymphony RGQ, a novel modular sample-to-result automation platform launched by Qiagen last year.
Source:Pharmabiz
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