Individual Response Monitoring Assay (IRMA) - Standardization of Personalized Multiplex Biomarker Quantification

The emerging demand for personalized cancer diagnostics is in conflict with an increasing challenge for assay standardization by regulatory authorities. Minimal residual disease (MRD) monitoring of acute lymphoblastic leukemia (ALL) patients is such an assay [1]. Here, patient-individual primer designs and PCR optimizations make assay standardization challenging. The IRMA approach combines three technological advances to provide a solution for standardized and patient-individual PCR assays: (1) Software assisted assay design (2) Modular assay technology (3) Microfluidic standardization.