FDA grants clearance for QIAGEN’s ipsogen JAK2 RGQ PCR Kit for detecting MPNs

U.S FDA grants clearance for QIAGEN’s ipsogen JAK2 RGQ PCR Kit for ascertaining myeloproliferative neoplasms (MPNs), which are a group of cancers in which immature blood cells in the bone marrow do not mature and become healthy blood cells. The FDA clearance now covers two additional types of MPN: essential thrombocythemia (ET) and primary myelofibrosis (PMF).

Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area said “We are eager to expand the use of our ipsogen JAK2 assay, which is already available in Europe and other markets, for use in a wider range of patients in the U.S. Our JAK2 assay makes it easier for hematologists and oncologists to follow recommended diagnostic testing algorithms and international guidelines for their patients suspected of having MPNs.”

Analysis of JAK2 is a major criterion for the diagnosis of all MPNs in the WHO (World Health Organization) 2016 guidelines for the classification of MPNs. MPNs are relatively rare with about 20,000 new cases per year, but about 5 suspected patients are tested for JAK2 to diagnose one case of MPN, which makes JAK2 among the most frequently performed molecular oncology tests.

U.S. 510k clearance comes after the FDA cleared the use of the ipsogen JAK2 assay as a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood*. This mutation is found in nearly all patients with polycythemia vera (PV), one of three types of MPNs that affect about 300,000 patients in the U.S.