Essential thrombocythemia
The US Food and Drug Administration (FDA) has cleared use of QIAGEN’s ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) for the diagnosis of all myeloproliferative neoplasms (MPNs).
The ipsogen JAK2 assay is a qualitative, in vitro diagnostic test designed to detect the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood.
The assay was previously cleared by the FDA for use in conjunction with other clinicopathological factors to aid the diagnosis of polycythemia vera.
Now, the FDA has cleared use of the assay for 2 additional MPNs—essential thrombocythemia and primary myelofibrosis.
“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 of QIAGEN’s Molecular Diagnostics Business Area.
“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 ipsogen JAK2 assay is a real-time PCR test performed on the QIAGEN Rotor-Gene Q MDx instrument.
The test is intended for use as an adjunct to the evaluation of suspected MPNs, in conjunction with other clinicopathological factors.
The ipsogen JAK2 assay does not detect less common JAK2 mutations associated with MPNs, including mutations in exon 12, and is not intended for stand-alone diagnosis of MPNs.
