FDA Marketing Approval for Polycythemia Vera Test Kit

The U.S. Food and Drug Administration (FDA) has granted marketing approval to the ipsogen JAK2 RGQ PCR Kit – the first FDA-authorized in vitro test for the evaluation of suspected polycythemia vera (PV). The testing kit detects mutations in the JAK2 gene in patients with suspected PV by sequencing data from DNA extracted from EDTA whole blood.

The marketing authorization was based on data from a clinical study of 216 patients with suspected PV, which compared results from the ipsogen JAK2 RGQ PCR Kit with those obtained from Sanger sequencing. The kit detected PV with a 94.6 percent sensitivity and 98.1 percent specificity.

According to the FDA’s press release announcing the decision, the kit should be used in combination with clinical, biologic, bone marrow histology, and cytogenetic criteria to confirm suspected PV.

Source: FDA press release, March 27, 2017.