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Kidney Week

Abstract: TH-PO1115

Multi-Center International Study to Validate a Pre-Transplant Blood-Based Next-Generation Sequencing (NGS) Signature Predicting Risk of Acute Rejection After Kidney Transplant

Session Information

  • Late-Breaking Posters
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Transplantation

  • 2102 Transplantation: Clinical

Authors

  • Gallon, Lorenzo G., Northwestern University, Evanston, Illinois, United States
  • Chang, Anthony, University of Chicago, Chicago, Illinois, United States
  • Donovan, Michael J., Verici Dx, Miami, Florida, United States
Background

Demographic and clinical features of both a kidney donor and recipient are utilized to estimate risk and likelihood of graft failure. Unfortunately, many of these features have performed poorly at predicting likelihood of early acute rejection (EAR). Clinically and analytically validated biomarkers are needed to assist in guiding medical management in the early months following transplant. We report on the development and validation of a novel, next-generation sequencing (NGS) biomarker assay which interrogates the immunologic profile of pre- transplant patients receiving a cadaveric donor kidney. By applying algorithm-enabled clinical decision trees, an RNA targeted NGS feature set predicting the likelihood of EAR was developed. The assay is performed in a CLIA environment to provide clinical grade results.

Methods

14 participating sites in US, Italy, Spain, France and Australia contributed to the validation cohort of 122 participants. All participants had blood collected prior to surgery. Patients were followed at 1and 3 month visits and had a protocol biopsy at 3 months as well as anytime for-cause; all biopsies were read centrally. Clinical endpoint of EAR was histopathology according to BANFF criteria which included TCMR 1A or higher, ABMR or mixed EAR.

Results

The assay performance results in risk classification of low risk or high-risk correlated to defined outcome of EAR on histopathology in the first 60 days following transplant producing an AUC of 0.719, p = 0.013. The sensitivity was 0.78, and the specificity was 0.64; the odds ratio was 6.133.

Conclusion

The correlation of a blood-based NGS signature with kidney biopsy histopathology provides a diverse and robust platform of enriched clinical evidence not traditionally reported in kidney transplant. A pre-transplant immunologic risk assessment tool has the potential to yield a novel, more precise level of evidence for clinicians and their patients at a critical time in their pre-surgical preparedness.

Funding

  • Commercial Support – Verici Dx