FDA Approved First JAK2 Assay to Help Diagnose Polycythemia Vera

On 27 March 2017, the FDA granted marketing authorization for the ipsogen JAK2 RGQ PCR Kit (QIAGEN GmbH), a diagnostic kit that detects V617F/G1849T mutation in the Janus-associated tyrosine kinase 2 (JAK2) gene, to be used as adjunct to clinicopathologic factors in evaluation of suspected polycythemia vera (PV). The JAK2 V617F/G1849T mutation is detected in more than 94 percent of patients with PV.

The kit uses real-time polymerase chain reaction (PCR) on the Qiagen Rotor-Gene Q MDx instrument (RGQ-PCR) to detect the JAK2 V617F/G1849T allele in genomic DNA. Its accuracy was validated in a clinical study in which results from the ipsogen JAK2 RGQ PCR Kit were compared to results obtained with Sanger sequencing in 216 patients with suspected PV. The ipsogen kit detected PV with 94.6% sensitivity and 98.1% specificity. This is the first diagnostic kit authorized by the FDA for evaluation of suspected PV.


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