Validation of CLL ERIC MRD Flow CytometryPanel in a CAP/CLIA-Compliant Model

ICCS 2020 -- With the advances made in new cancer therapies, many CLL (Chronic Lymphocytic Leukemia) patient remission rates are significantly improving. As a result, MRD (Minimal/Measurable Residual Disease) has also become an important predictor of survival in CLL and has been proposed as a potential surrogate endpoint for overall CLL survival in clinical trials. In order to assess MRD in CLL patients using flow cytometry, CLL ERIC MRD assay was originally developed and characterized by Rawstron et al. (2007 and 2013). Covance Central Laboratory Services (CCLS) adapted this assay for its use in a central laboratory environment and performed assay validation to confirm performance of the assay in terms of precision, sensitivity and stability, while including run pass fail criteria using QC reagents.