What is the best end-point in clinical trials of drugs for cancer?
Our method is capable of detecting one cancer cell among 10.000-1.000.000 cells with a higher specificity than standard methods (Flow Cytometry). Our method has high applicability >95% for Myeloma and >85% in acute myeloid leukemia.
Our method has been validated in clinical studies in multiple myeloma and acute myeloid leukemia where MRD by NGS for this method is associated with Overall Survival. At present, MRD tracking has been correlated with clinical outcome in chronic lymphoid leukemia, myelodysplastic syndrome, non-Hodgkin lymphoma, and is under study in other solid tumor diseases.
This methodology is employed as an end-point in clinical trials as a biomarker of response.