FDA Grants Marketing Authorization for Ipsogen JAK2 RGQ PCR Kit to Detect JAK2 Genetic Mutations

The U.S. Food and Drug Administration (FDA) has granted marketing authorization to the ipsogen JAK2 RGQ PCR Kit, manufactured by QIAGEN GmbH, to detect mutations affecting the Janus tyrosine kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected polycythemia vera.

Diagnoses of polycythemia vera are based on clinical, biologic, bone marrow histology, and cytogenetic criteria. The presence of JAK2 mutations is one of the major criteria for clinical confirmation of the disease. The V617F/G1849T mutation affecting the JAK2 gene is detected in more than 94% of patients with polycythemia vera.

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 kit is a real-time polymerase chain reaction (PCR) test performed on the QIAGEN Rotor-Gene Q MDx instrument. The test is intended for use as an adjunct to evaluation of suspected polycythemia vera, in conjunction with other clinicopathologic factors. It does not detect less common mutations associated with polycythemia vera, including mutations in exon 12, and is not intended for stand-alone diagnosis of polycythemia vera.

The device marketing authorization, granted March 27, 2017, was based on data from a clinical study of 216 suspected patients with polycythemia vera. The study compared results from the ipsogen JAK2 RGQ PCR Kit to results obtained with Sanger sequencing when each is used as a major criterion as described in World Health Organization criteria for evaluating whether a patient has polycythemia vera. In the study, the ipsogen JAK2 RGQ PCR Kit test detected the disorder with 94.6% sensitivity and 98.1% specificity.

Further information about the JAK2 RGQ PCR Kit is available at:

https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160028.pdf

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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