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Abstract: SA-PO1052

Blood Gene Expression Profile and dd-cfDNA for Diagnosis of Persistent Rejection 

Session Information

Category: Transplantation

  • 2102 Transplantation: Clinical

Authors

  • Fleming, James, Transplant Genomics, Framingham, Massachusetts, United States
  • Park, Sookhyeon, Northwestern University, Evanston, Illinois, United States
  • Rebello, Christabel, Northwestern University, Evanston, Illinois, United States
  • Kleiboeker, Steven, Eurofins Viracor, Lenexa, Kansas, United States
  • Holman, John M., Transplant Genomics, Framingham, Massachusetts, United States
  • Friedewald, John J., Northwestern University, Evanston, Illinois, United States
Background

Persistent rejection (PRx) after treatment of BPAR is increasingly recognized and associated with worse outcomes. Repeat biopsies in the absence of clinical concern are rare.

Methods

This was a post hoc analysis performed on subjects with BPAR from the CTOT-08 study that had repeat biopsies available within 270 days after BPAR, and subanalysis of those within 90 days.

Results

Overall, 64 “index” BPAR with repeat biopsies were identified and 61% had PRx within 270 days. Rejection types are in Figure 2. Biomarker test characteristics for F/U biopsies within 270 days and 90 days are shown in Figure 1. PRx was in clinically stable patients in 67% within 270 and 71% within 90 days. Biomarker results and rejection type are shown in Figure 2. There was 2-year clinical F/U data available for 52 subjects showing 32 subjects (62%) met the composite endpoint of the CTOT-08 trial and subjects with PRx were more likely to meet the CCE (65% vs 34%, p=0.025).

Conclusion

Blood GEP and dd-cfDNA demonstrate excellent capability of identifying PRx, with high PPVs. PRx was associated with worse outcomes. GEP and dd-cfDNA may be tools to identify those in need of a F/U biopsy even when no clinical alterations are present (2/3 of subjects had stable function). The overlap of biomarker results shows that the 2 tests identify different rejections.

Funding

  • Other NIH Support – Transplant Genomics, Inc