Qiagen has announced the US launch of its ipsogen JAK2 RGQ PCR (ipsogen JAK2 assay), which was cleared by the US Food and Drug Administration (USFDA) 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.