QIAGEN N.V. Launches First FDA-Cleared JAK2 Test For Certain Type Of Leukemia

This article was originally published here

GERMANTOWN, Maryland, and HILDEN, Germany, March 29, 2017 /PRNewswire/ —

QIAGEN N.V. (NASDAQ: QGEN; FRANKFURT PRIME STANDARD: QIA) today announced the U.S. launch of its ipsogen® JAK2 RGQ PCR Kit (ipsogen JAK2 assay), which was cleared by the U.S. Food and Drug Administration as 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 assay is processed on QIAGEN’s Rotor-Gene® Q MDx system, which is a member of the modular QIAsymphony® family of automation solutions that offers a full Sample to Insight workflow. It also marks the fifth 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.

QIAGEN’s ipsogen JAK2 assay is the first and only FDA-cleared kit for the JAK2 V617F mutation, which found in nearly all patients with Polycythemia Vera and belongs to a group of blood cancers known as myeloproliferative neoplasms (MPNs) that affect about 300,000 patients in the United States. The JAK2 V617F mutation is important for the diagnosis of Polycythemia Vera (PV), according to the 2016 World Health Organization classification of myeloid neoplasms. About 9,000 new PV cases a year are diagnosed.

Click here for the full press release




0 replies

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply