NEW YORK (GenomeWeb) – Qiagen said after the close of the market on Tuesday that it received US Food and Drug Administration clearance for its Ipsogen JAK2 RGQ PCR Kit for additional use in the diagnosis of all myeloproliferative neoplasms (MPNs).
In March 2017 the FDA cleared the assay as a qualitative in vitro diagnostics test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood to aid in the diagnosis of the blood cancer polycythemia vera.
The new FDA clearance now covers two additional types of MPNs: essential thrombocythemia and primary myelofibrosis.
The assay runs on Qiagen's Rotor-Gene Q MDx instrument, a component of the modular QiaSymphony family of laboratory automation products.
Qiagen said that it is the exclusive worldwide licensee of intellectual property covering the detection of the JAK2 V617F mutation for diagnostic purposes, and that it recently reached a settlement with an unspecified molecular diagnostics industry supplier in Europe, which agreed to stop selling its own JAK2 V617F test kit.
"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," Thierry Bernard, senior vice president and head of Qiagen's molecular diagnostics business area, said in a statement. The assay "makes it easier for hematologists and oncologists to follow recommended diagnostic testing algorithms and international guidelines for their patients suspected of having MPNs."
In Europe Qiagen also markets the CE-IVD marked Ipsogen CALR RGQ PCR Kit for detection and identification of various mutations of the calreticulin (CALR) gene in patients with suspected MPNs. This kit complements the Ipsogen JAK2 kit and can be processed on the QiaSymphony platform from a single patient sample, Qiagen said.
The company also noted that these genes are included in its myeloid next-generation sequencing panel, which is currently under development for use on the company's GeneReader NGS platform and is expected to launch later this year for research use.