Netherlands-based Qiagen has introduced its new biomarker test ipsogen JAK2 RGQ PCR kit (ipsogen JAK2 assay) in the US to detect the polycythemia vera (PV) form of leukaemia.
JAK2 RGQ PCR kit is a qualitative in-vitro diagnostic test designed to be used in combination with other clinicopathological factors to identify JAK2 V617F/G1849T allele in genomic DNA.
The JAK2 V617F mutation is reported to be found in a majority of patients with PV and is a part of blood cancers called myeloproliferative neoplasms (MPNs).
Qiagen Molecular Diagnostics Business Area senior vice-president and head Thierry Bernard said: “We are pleased to be able to offer our ipsogen JAK2 assay, which is already available in Europe and other markets, for use in the US and make it easier for hematologists and oncologists to follow recommended diagnostic testing algorithms and international guidelines for suspected PV patients."
The ipsogen JAK2 test has demonstrated positive outcome in a multi-centre, international, prospective, interventional study.
Processed on Qiagen's Rotor-Gene Q MDx system, the new test expands the firm's portfolio of assays for common and rare leukemia types.
The firm provides the CE-IVD-marked ipsogen CALR RGQ PCR kit in Europe, to identify and detect different mutations of the Calreticulin (CALR) gene in patients with suspected MPNs.
Both the JAK2 and CARL kits can be processed from a single patient sample on the QIAsymphony platform and are included in the firm's MPN and leukemia NGS panels being developed for its GeneReader NGS platform.
Qiagen holds the exclusive intellectual property rights covering detection of the V617F JAK2 and CALR mutations.