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# FDA Clears Qiagen JAK2 Mutation Detector
- URL: https://www.fdaweb.com/fda-clears-qiagen-jak2-mutation-detector/
- Published: 2017-04-07T12:00:00.000Z
- Updated: 2026-09-14T22:16:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138403

FDA has cleared a Qiagen 510(k) for the ipsogen JAK2 RGQ PCR Kit for detecting 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), according to the [agency](https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm551474.htm?ref=fdaweb.com).

  
Diagnoses of PV are based on clinical, biological, bone marrow histology and cytogenetic criteria, the agency says, adding that the presence of JAK2 mutations is one of the major criteria for clinical confirmation. 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 PV diagnosis.