HalioDx performed development work for ipsogen® JAK2 510(k) clearance by QIAGEN

Marseille, France, March 30, 2017 - HalioDx SAS, an immuno-oncology diagnostic company, today announced that its R&D collaboration with QIAGEN N.V., a leading global provider of Sample to Insight solutions, has resulted in a U.S. Food and Drug Administration (FDA) 510(k) clearance for QIAGEN's ipsogen® JAK2 RGQ PCR test. 

The ipsogen® JAK2 RGQ PCR test is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. It is a real time PCR test performed on the QIAGEN Rotor-Gene Q MDx instrument. The test is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors and will be marketed by QIAGEN as part of their Personalized Healthcare assays portfolio.

HalioDx performed feasibility & development phases including clinical validation on behalf of QIAGEN. Design, verification & validation phases were led by HalioDx on the basis of IDE & pre-IDE approvals. The clinical performance of the ipsogen JAK2 RGQ PCR Kit was evaluated during a multicenter, international, prospective, interventional study conducted by HalioDx. The study had successful patient enrollment at 7 sites in the United States, 12 sites in France, and 5 sites in Italy.

Vincent FERT, CEO of HalioDx comments: "By successfully achieving this project on behalf of QIAGEN we have demonstrated our expertise and capabilities to drive IVD projects through complex US IVD regulatory path. The commitment of our team and the excellent collaboration framework with our partner QIAGEN and international clinical centres exemplify how we want to drive HalioDx company value in the near future. We intend to leverage this expertise with QIAGEN but also with our growing biopharma partners in immuno-oncology".