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The MMDx® diagnostic system: A critical re‐appraisal of its knowledge gaps and a call for rigorous validation studies

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Transcriptomics generates pathogenetic insights not obtainable by histology, but translation of these insights into diagnostic tests is not a trivial task. This opinion‐piece critically appraises declarative MMDx statements, such as… Click to show full abstract

Transcriptomics generates pathogenetic insights not obtainable by histology, but translation of these insights into diagnostic tests is not a trivial task. This opinion‐piece critically appraises declarative MMDx statements, such as the infallibility of machine learning algorithms, measurements of gene expression with >99% precision, and “unambiguous reclassifications” of contentious biopsies such as those with borderline change, polyomavirus nephropathy, chronic active T‐cell or mixed rejection, isolated intimal arteritis, and renal medullary pathology.

Keywords: critical appraisal; appraisal knowledge; mmdx diagnostic; knowledge gaps; system critical; diagnostic system

Journal Title: Clinical Transplantation
Year Published: 2022

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