Clinical laboratory validation of the MCL35 assay for molecular risk stratification of mantle cell lymphoma

In this study, we sought to explore the performance characteristics of the MCL35 assay in a clinical laboratory and compare r esults with the Ki67 proliferation marker. The results describe the clinical validation of the MCL35 assay for molecular risk stratification of MCL including accuracy, sensitivity, specificity, use in acid-decalcified bone marrow core biopsies, fixatives, lower limit of RNA input, quality metrics, a nd other laboratory parameters. The resulting data indicate that this is a robust technique with outstanding reproducibility. Overall, the data support the concept of molecular signatures, as assessed with digital gene expression profiling, for improved standardization and reproducibility for prolif eration assessment in MCL.
Source: Journal of Hematopathology - Category: Pathology Source Type: research