First JAK2 Test for MPNs Gets FDA Clearance


The ipsogen JAK2 RGQ PCR Kit received clearance from the U.S. FDA for additional use in the diagnosis of all myeloproliferative neoplasms.

Last night, the ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) received clearance from the U.S. Food and Drug Administration (FDA) for additional use in the diagnosis of all myeloproliferative neoplasms (MPNs).

QIAGEN, the developers of the kit, has announced that the FDA clearance now covers 2 additional types of MPNs: essential thrombocythemia (ET) and primary myelofibrosis (PMF). The assay is processed on QIAGEN's Rotor-Gene Q MDx instrument, and is the company’s sixth FDA clearance or approval of an oncology-related test for personalized healthcare.

The clearance came after the FDA also cleared the use of 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.

MPNs are a group of cancers in which immature blood cells in the bone marrow do not fully develop, and are prohibited from maturing into healthy blood cells. In thrombocythemia, excess platelets are produced, leading to abnormal blood clotting or bleeding. Myelofibrosis often results in extensive scarring in the bone marrow, leading to anemia, fatigue, and an increased risk of bleeding and infection.

“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,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area, in a press release. “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 newly cleared test was developed for use as an aide to evaluation of assumed MPNs, in conjunction with other clinicopathological factors. This test, however, does not detect less common JAK2 mutations associated with MPNs, including mutations in exon 12 and is not intended for standalone diagnosis of myeloproliferative neoplasms.

In the video below, Daniel DeAngelo, M.D., Ph.D. discusses typical presentation and diagnostic criteria for PMF.

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