The Food and Drug Administration (FDA) has approved the ipsogen JAK2 RGQ PCR Kit (Qiagen), the first authorized test intended to help clinicians evaluate patients for suspected polycythemia vera (PV).
The presence of JAK2 mutations is one of the major criteria for clinical confirmation of PV. The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood; the V617F/G1849T mutation affecting the JAK2 gene is detected in > 94% of patients with PV. The test can be used as an adjunct to evaluation of suspected PV, in conjunction with other clinicopathological factors.
The approval is based on data from a trial of 216 suspected patients with PV which compared results from the ipsogen JAK2 RGQ PCR Kit to those obtained with Sanger sequencing when each is used as a major criterion as described in WHO criteria. In the study, the ipsogen JAK2 RGQ PCR Kit test detected PV with 94.6% sensitivity and 98.1% specificity.
The ipsogen JAK2 RGQ PCR Kit does not detect less common mutations associated with PV including mutations in exon 12. It is also not intended for stand-alone diagnosis of PV.
For more information visit FDA.gov.