PentaBase is pleased to announce the release of the PlentiPlex™ Mastocytosis CE IVD assay. The PlentiPlex™ Mastocytosis CE IVD in vitro diagnostic assay is intended for detection of the KIT D816V mutation in human genomic DNA from whole blood samples to assist the diagnosis of mastocytosis. PlentiPlex™ Mastocytosis CE IVD has been developed in a collaboration between Mastocytosis Centre Odense University Hospital (MastOUH) and PentaBase for use with Applied Biosystems QuantStudio™ Real-Time PCR Systems. Clinical validation of PlentiPlex™ Mastocytosis CE IVD demonstrated 100% specificity and 0.01% limit of detection in a retrospective study using whole blood samples from KIT D816V-mutation positive MastOUH-patients and controls (Kristensen et al. manuscript submitted for publication).