Recently, Qiagen (QGEN) entered into a partnership with Eli Lilly and Company (LLY), a global pharmaceutical product manufacturer. As per the terms of the partnership, both the companies will jointly develop, manufacture and commercialize a molecular companion diagnostic for an early-stage investigational compound, which is currently being developed by Lilly. However, financial terms of the agreement have not been disclosed.
With the collaboration, both the companies will combine their proprietary technologies, JAK2 inhibitor of Lilly and Qiagen’s assay for JAK2 V617F. Qiagen expects to develop a new companion diagnostic test that will provide both qualitative and quantitative results for JAK2 V617F. Thus, Qiagen expects this deal to be accretive in terms of expanding the scope of use of its JAK2 assay during clinical trials as well as developing a diagnostic product in parallel with the Lilly compound.
Presently, Qiagen offers about 20 tests for use in personalized healthcare and works in collaboration with more than 15 pharma companies in order to co-develop companion diagnostics. The JAK2 V617F assay is currently offered by clinical labs in the form of lab-developed tests (LDTs). The new companion diagnostic test with Lilly will run on Qiagen's Rotor-Gene Q instrument and will be solely marketed by Qiagen. Currently, the company is also waiting for the regulatory approval of full automation of the workflow on the QIAsymphony RGQ.
Earlier in August 2011, Qiagen entered into an agreement with Pfizer Inc. (PFE) to develop a companion molecular diagnostic test for use with an investigational Pfizer compound for treating non-small cell lung cancer (NSCLC). The proposed test will use the same core assay component as Qiagen’s proprietary KRAS assay technology, which detects mutations of the KRAS gene, frequently found in human colorectal cancers.
Companion diagnostics are currently gaining significant traction and peers of Qiagen like Myriad Genetics (MYGN) are establishing themselves as strong players in the companion diagnostics market. However, this latest move on Qiagen’s part is expected to strengthen its foothold in this market by combining its excellence in companion diagnostics with Lilly's strong scientific and global background.
The molecular diagnostics segment of Qiagen contributed 46% of the total sales in the second quarter of fiscal 2011 and rose 2% at constant exchange rate (CER) on the back of solid growth in consumable products, partially offset by lower instrument sales. However, the comparison was hampered by higher one-time contributions in the prior-year quarter, which included payments for companion diagnostic co-development projects to pharmaceutical companies.
Going forward, the company expects a wave of newly discovered biomarkers and companion diagnostics to transform the treatment of a number of diseases.
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