Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

FDA Grants Marketing Authorisation to Ipsogen JAK2 RGQ PCR Kit

The kit detects mutations affecting the JAK2 gene
10 Apr 2017
Targeted Therapy
Haematological Malignancies

The US Food and Drug Administration (FDA) has granted marketing authorisation 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-authorised 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% 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 authorisation, granted on 27 March, 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% sensitivity and 98.1% specificity.

Further information about the JAK2 RGQ PCR Kit is available here

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.

Last update: 10 Apr 2017

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.