The FDA has cleared the ipsogen JAK2 assay for additional use in the diagnosis of all 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.
This 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, one of three types of MPNs that affect about 300,000 patients in the U.S.
The FDA clearance now covers two additional types of MPN: essential thrombocythemia and primary myelofibrosis.
The analysis of JAK2 is a major criterion for the diagnosis of all MPNs in the WHO 2016 guidelines for the classification of MPNs. MPNs are relatively rare with about 20,000 new cases per year, but about five suspected patients are tested for JAK2 to diagnose one case of MPN, which makes JAK2 among the most frequently performed molecular oncology tests.