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Multi-cell-type, 3D microphysiological systems (MPS) that recapitulate normal organ/organ system functions and the progression of diseases are being applied in drug discovery and development programs to enable precision medicine. A critical step for this application is to demonstrate the reproducibility of the MPS and its ability to identify biologic/clinical heterogeneity from experimental variability, which requires capturing detailed metadata associated with MPS studies as well as a strong analytical approach for assessing reproducibility. Detailed metadata ensure that identical study parameters are being compared when evaluating reproducibility. We have developed the Pittsburgh reproducibility protocol (PReP), which uses a set of common statistical metrics, the coefficient of variation (CV), ANOVA, and intraclass correlation coefficient (ICC), in a pipeline as a standard approach to evaluate the intra- and interstudy reproducibility of MPS performance. The PReP can be employed to identify biological/clinical heterogeneity relevant to precision medicine.
Miedel et al. (Tue,) studied this question.