Journal
AMERICAN JOURNAL OF TRANSPLANTATION
Volume 13, Issue 9, Pages 2352-2363Publisher
WILEY
DOI: 10.1111/ajt.12387
Keywords
Classifier; kidney transplant; microarrays; molecular diagnostics; T cell-mediated rejection
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Funding
- Novartis Pharma AG
- Genome Canada
- University of Alberta Hospital Foundation
- Roche Molecular Systems
- Hoffmann-La Roche Canada Ltd.
- Alberta Ministry of Advanced Education and Technology
- Roche Organ Transplant Research Foundation
- Astellas
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We previously developed a microarray-based test for T cell-mediated rejection (TCMR) in a reference set of 403 biopsies. To determine the potential impact of this test in clinical practice, we undertook INTERCOM, a prospective international study of 300 indication biopsies from 264 patients (ClinicalTrials.gov NCT01299168). Biopsies from six centersBaltimore, Barcelona, Edmonton, Hannover, Manchester and Minneapoliswere analyzed by microarrays, assigning TCMR scores by an algorithm developed in the reference set and comparing TCMR scores to local histology assessment. The TCMR score correlated with histologic TCMR lesionstubulitis and interstitial infiltration. The accuracy for primary histologic diagnoses (0.87) was similar to the reference set (0.89). The TCMR scores reclassified 77/300 biopsies (26%): 16 histologic TCMR were molecularly non-TCMR; 15 histologic non-TCMR were molecularly TCMR, including 6 with polyoma virus nephropathy; and all 46 borderline biopsies were reclassified as TCMR (8) or non-TCMR (38). Like the reference set, discrepancies were primarily in situations where histology has known limitations, for example, in biopsies with scarring and inflammation/tubulitis potentially from other diseases. Neither the TCMR score nor histologic TCMR was associated with graft loss. Thus the molecular TCMR score has potential to add new insight, particularly in situations where histology is ambiguous or potentially misleading.
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