QIAGEN Receives FDA Clearance for JAK2 Diagnostic Test
QIAGEN announced that it has received clearance for its ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) from the U.S. Food and Drug Administration (FDA) 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 (PV), 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 (ET) and primary myelofibrosis (PMF).
The 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.
“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,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area.
QIAGEN is at the forefront of developing oncology tests to diagnose, guide the selection of therapies and monitor the treatment of cancer patients. QIAGEN offers a range of personalized healthcare assays for use around the world under the ipsogen (blood cancers) and therascreen (solid tumors) brands, covering about 30 biomarkers and spanning a range of automation platforms and tumor sample types.
QIAGEN is the exclusive worldwide licensee of intellectual property rights that cover the detection of the V617F JAK2 mutation for diagnostic purposes, and offers the only FDA-cleared JAK2 test. QIAGEN recently reached a settlement with a molecular diagnostics industry supplier in Europe, which agreed to stop selling its own JAK2 V617F kit, after a court-appointed expert issued a positive opinion in favor of QIAGEN in regard to the validity and infringement of the licensed intellectual property. QIAGEN has a strong position for JAK2 intellectual property, and intends to assert its rights to protect this technology.
The ipsogen JAK2 assay is the latest addition to QIAGEN’s ipsogen market-leading portfolio of assays for common and rare leukemia types. In Europe, QIAGEN offers the CE-IVD marked ipsogen CALR RGQ PCR Kit for identification and detection of various mutations of the calreticulin (CALR) gene in patients with suspected MPNs. QIAGEN is also the exclusive licensee of intellectual property rights covering detection CALR mutations for diagnostic purposes. The ipsogen JAK2 and CALR test kits are highly synergistic, and can be processed on the QIAsymphony platform from a single patient sample. These genes are also included in the myeloid NGS panel which QIAGEN is currently developing for its GeneReader NGS platform and which is expected to launch later in the year for clinical research.
The ipsogen JAK2 assay is processed on QIAGEN’s Rotor-Gene Q MDx instrument, which is a member of the modular QIAsymphony family of automation solutions that offers a full Sample to Insight workflow. It also marks the sixth FDA clearance or approval of a QIAGEN oncology-related test for personalized healthcare. QIAGEN continues to expand its pipeline of Sample to Insight technologies for personalized healthcare applications and intends to submit more tests for regulatory clearance or approval. More than 20 master collaboration agreements have been reached with leading pharmaceutical and biotech companies to co-develop and market companion diagnostics assays.
* The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The ipsogen JAK2 RGQ PCR Kit 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 evaluation of suspected myeloproliferative neoplasms, in conjunction with other clinicopathological factors. This test does not detect less common JAK2 mutations associated with myeloproliferative neoplasms including mutations in exon 12 and is not intended for standalone diagnosis of myeloproliferative neoplasms.