Qiagen and Lilly have teamed up to co-develop a companion diagnostic for use alongside the latter’s early-stage JAK2 inhibitor blood cancers candidate. The assay will be developed to qualitatively and quantitatively test for JAK2 V617F mutation, in order to identify patients most likely to benefit from the pathway inhibitor.
The agreement covers development and use of the Qiagen JAK2 assay during clinical studies, as well as manufacturing and joint commercialization of the test in parallel with the Lilly drug. Qiagen notes JAK2 V617F testing is already being offered by clinical labs in the form of laboratory-developed tests. The PCR-based companion diagnostic developed for Lilly’s drug will be exclusively marketed by Qiagen and run on its Rotor-Gene Q instrument. The firm says it also plans to work toward regulatory approval for full automation of the workflow on the QIAsymphony RGQ system, which it launched in 2010.
Qiagen exclusively licensed the JAK2 biomarker from Ipsogen, a French cancer profiling firm which Qiagen is currently in the process of buying out. Ipsogen already offers a family of qualitative and quantitative CE-marked MutaQuant™, MutaSearch™, and MutaScreen™ kits for the JAK2 V617F mutation. Just last month the firm announced that its MutaQuant JAK2 had been selected by the MyeloProliferative Disorders Research Consortium to assess the JAK V617F mutation load in two international multicenter trials supported by the National Cancer Institute and Roche, in patients with Polycythemia Vera or Essential Thrombocythemia.