Digital PCR (Dpcr) a Step Forward to Detection and Quantification of Minimal Residual Disease (MRD) in Ph+/BCR-ABL1 Chronic Myeloid Leukemia (CML)

Digital PCR improves the quantitation of DMR and the selection of CML candidates to TKIs discontinuation

“…Receiver operator curves analysis was done to recalculate the optimal dPCR cutoff value to discriminate the patients with DMR and lower probability to lose MR 3.0 after TKI discontinuation. Notably, a cutoff of 0.468 was found to be coincidental with the previous one identified discriminating the deep molecular responders by dPCR . This value divided patients with lower risk of disease molecular relapse better, with an area under the curve of 0.69 (CI 95% 0.57‐0.81), specificity of 85% and sensitivity of 54% (Figure ).…”

“…A new receiver operating characteristic (ROC) curve analysis was carried out on the present cohort of patients and confirmed the reliability of the abovementioned cutoff in identification of the DMR patients by dPCR. (Figure ) …”

“…The dPCR analysis was centralized at the Laboratory CREA (Centro di Ricerca Emato‐Oncologico AIL) of the ASST Spedali Civili of Brescia and performed as previously described …”

“…The amplification was followed by the chips imaging and the secondary analysis performed with the QuantStudio 3D AnalysisSuite Cloud Software. All samples were analyzed twice by different operators and the final results were expressed as means of the number of BCR‐ABL1 copies/µL of reaction of the replicates …”

“…Although the dPCR is not yet routinely applied for the standard analysis of molecular MRD in CML, preliminary data suggest that it is more sensitive and accurate than RT‐qPCR for monitoring the BCR‐ABL1 transcript levels and, possibly, for predicting the patients who are going to relapse after discontinuation of TKI …”