The U.S. Food and Drug Administration (FDA) granted marketing authorization to ipsogen JAK2 RGQ PCR Kit for the detection of JAK2 mutations. This is the first FDA-approved test to evaluate patients with suspected polycythemia vera (PV). The device is a qualitative in vitro diagnostic test for real-time polymerase chain reaction on the Rotor-Gene Q MDx instrument to detect the JAK2 V617F/G1849T allele.
The marketing authorization was based on a clinical trial that included 216 individuals with suspected PV. The researchers compared the test characteristics of the ipsogen JAK2 RGQ PCR Kit with Sanger sequencing. The ipsogen JAK2 RGQ PCR Kit detected PV with 94.6 percent sensitivity and 98.1 percent specificity.
The test does not detect less common mutations associated with PV, including mutations in exon 12, and should be used to diagnosis the disease in combination with an assessment of other known clinical, biologic, bone marrow histology, and cytogenetic criteria, according to the FDA.
Source: U.S. Food and Drug Administration news release, March 27, 2017.