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FDA grants marketing authorization to genomic sequencing kit for suspected polycythemia vera
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The FDA granted marketing authorization to ipsogen JAK2 RGQ PCR Kit for the detection of mutations affecting the JAK2 gene, according to the device’s manufacturer.
The ipsogen JAK2 RGQ PCR Kit (Qiagen) is a qualitative in vitro diagnostic test for real-time polymerase chain reaction on the Rotor-Gene Q MDx instrument (Qiagen) to detect the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood.
The kit is the first FDA–authorized test intended to help physicians evaluate patients for suspected polycythemia vera. Harboring JAK2 mutations is one of the major criteria for a clinical confirmation of polycythemia vera, with the V617F/G1849T allele present in more than 94% of patients.
Marketing authorization was based on a clinical study of the kit used in 216 individuals with suspected polycythemia vera compared with results obtained with Sanger sequencing (Applied Biosystems).
The ipsogen JAK2 RGQ PCR Kit test detected polycythemia vera with 94.6% sensitivity and 98.1% specificity.
The test does not detect less common mutations associated with polycythemia vera — including mutations in exon 12 — and should be used to diagnosis the disease in combination with an assessment of other known clinical, biological, bone marrow histology and cytogenetic criteria.