Qiagen launches JAK2 test
April 17, 2017—Qiagen launched its Ipsogen JAK2 RGQ PCR Kit, which was cleared by the Food and Drug Administration as a qualitative IVD test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The JAK2 assay is processed on Qiagen’s Rotor-Gene Q MDx system.
Qiagen says its Ipsogen JAK2 assay is the first FDA-cleared kit for the JAK2 V617F mutation, important for the diagnosis of polycythemia vera, according to the 2016 WHO classification of myeloid neoplasms.
Qiagen reported that the clinical performance of the Ipsogen JAK2 assay was evaluated during a multicenter, international, prospective, interventional study. The study demonstrated 94.6 percent sensitivity and 98.1 percent specificity for the diagnosis of PV, together with a 100 percent positive percentage agreement and a 99.4 percent negative percentage agreement to bidirectional sequencing.