FDA Approves First JAK2 Assay for MPNs
The US Food and Drug Administration (FDA) has approved the ipsogen JAK2 assay for use in the diagnosis of all myeloproliferative neoplasms (MPNs).
Qiagen, the developer of the ipsogen JAK2 RGQ PCR Kit, announced the FDA clearance now covers two additional types of MPNs: essential thrombocythemia and primary myelofibrosis. Clearance came following the FDA also cleared the use of ipsogen JAK2 assay as an in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA.
“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 US,” said Thierry Bernard, Senior Vice President and Head, Qiagen’s Molecular Diagnostics Business Area, in a press release (January 23, 2018). “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.”
The test was developed for use as an aide to assessment of suspected MPNs, in conjunction with other clinicopathologic factors. However, the ipsogen JAK2 assay does not detect less common JAK2 mutations associated with MPNs, including exon 12. The assay is also not intended for standalone diagnosis of MPNs.—Zachary Bessette