Transformative impact of Flow-SuperRCA on the diagnostic landscape of clonal MCDs. This figure illustrates the transformative impact of Flow-SuperRCA technology compared with the conventional ASO-qPCR method for detecting KIT p.D816V in MCAS and SM including BMM. The left panel summarizes the current limitations of ASO-qPCR, including its restricted sensitivity (LOD: 0.01%), the frequent need for BM biopsy, and the potential for diagnostic uncertainty or misclassification, particularly in patients with low mast cell burden, such as MMAS, BMM, and nc-MCAS. The middle panel emphasizes the key advantages of Flow-SuperRCA, which offers a 10-fold increase in sensitivity (LOD: 0.001%) and enables direct detection of KIT p.D816V in PB and BM samples. This enhanced performance results in reclassification of 18% of previously diagnosed nc-MCAS cases as clonal MCAS, and in detection of BMM cases without skin involvement, cases often missed by ASO-qPCR. The right panel outlines the downstream clinical implications of implementing Flow-SuperRCA, including earlier diagnosis, reduced need for invasive procedures (PB-based screening), improved identification of clonal MCD, and potential for MRD monitoring. In clinical terms, Flow-SuperRCA increased detection rates in MMAS (64% vs 7% with ASO-qPCR), and achieved a diagnostic accuracy of 88% in PB across all SM subtypes, substantially higher than ASO-qPCR (57%). These results support its integration into updated diagnostic algorithms and WHO/ECNM classifications. ECNM, European Competence Network on Mastocytosis; LOD, limit of detection; MRD, minimal residual disease; WHO, World Health Organization.

Transformative impact of Flow-SuperRCA on the diagnostic landscape of clonal MCDs. This figure illustrates the transformative impact of Flow-SuperRCA technology compared with the conventional ASO-qPCR method for detecting KIT p.D816V in MCAS and SM including BMM. The left panel summarizes the current limitations of ASO-qPCR, including its restricted sensitivity (LOD: 0.01%), the frequent need for BM biopsy, and the potential for diagnostic uncertainty or misclassification, particularly in patients with low mast cell burden, such as MMAS, BMM, and nc-MCAS. The middle panel emphasizes the key advantages of Flow-SuperRCA, which offers a 10-fold increase in sensitivity (LOD: 0.001%) and enables direct detection of KIT p.D816V in PB and BM samples. This enhanced performance results in reclassification of 18% of previously diagnosed nc-MCAS cases as clonal MCAS, and in detection of BMM cases without skin involvement, cases often missed by ASO-qPCR. The right panel outlines the downstream clinical implications of implementing Flow-SuperRCA, including earlier diagnosis, reduced need for invasive procedures (PB-based screening), improved identification of clonal MCD, and potential for MRD monitoring. In clinical terms, Flow-SuperRCA increased detection rates in MMAS (64% vs 7% with ASO-qPCR), and achieved a diagnostic accuracy of 88% in PB across all SM subtypes, substantially higher than ASO-qPCR (57%). These results support its integration into updated diagnostic algorithms and WHO/ECNM classifications. ECNM, European Competence Network on Mastocytosis; LOD, limit of detection; MRD, minimal residual disease; WHO, World Health Organization.

or Create an Account

Close Modal
Close Modal