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# FDA Clears Qiagen JAK2 Assay
- URL: https://www.fdaweb.com/fda-clears-qiagen-jak2-assay/
- Published: 2017-03-31T12:00:00.000Z
- Updated: 2026-09-14T22:15:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138354

FDA has cleared a Qiagen 510(k) for its Ipsogen JAK2 RGQ PCR Kit (*ipsogen* JAK2 assay) for use as a qualitative *in vitro* diagnostic test for detecting JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood, which is found in nearly all patients with Polycythemia Vera and belongs to a group of blood cancers known as myeloproliferative neoplasms. The assay is processed on Qiagen’s Rotor-Gene Q MDx system.