FDA Approves Marketing Ipsogen JAK2 RGQ PCR Kit to Help Evaluate Suspected Polycythemia Vera

April 07, 2017
FDA Update

The U.S. Food and Drug Administration (FDA) has granted marketing authorization to 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 (PV).

Diagnoses of PV are based on clinical, biological, bone marrow histology and cytogenetic criteria. The presence of JAK2 mutations is one of the major criteria for clinical confirmation of PV. The V617F/G1849T mutation affecting the JAK2 gene is detected in more than 94 percent of patients with 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 kit is a real time PCR test performed on the QIAGEN Rotor-Gene Q MDx instrument. The test is intended for use as an adjunct to evaluation of suspected PV, in conjunction with other clinicopathological factors. This test does not detect less common mutations associated with PV including mutations in exon 12 and is not intended for stand-alone diagnosis of PV.

The device marketing authorization, granted March 27, 2017, was based on data from a clinical study of 216 suspected patients with PV. 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 WHO criteria for evaluating whether a patient has PV. In the study, the ipsogen JAK2 RGQ PCR Kit test detected PV with 94.6 percent sensitivity and 98.1 percent specificity.

Further information about the JAK2 RGQ PCR Kit is available (https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160028.pdf).

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online (http://www.fda.gov/medwatch/report.htm), by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

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