Transplantationstechnologien und Forschung

Evidence of Clinical Utility: An Investigator Assessment of a Novel Blood-Based Biomarker of Liver Transplant Rejection to Guide Immunosuppression Decisions

Abstract

Weems Juston, Holman John1, Rose Stanley, Abecassis Michael M , Levitsky Josh

Background: We have previously discovered and validated a microarray-based test that analyzes blood gene expression profiles (GEP) as an indicator of immune status in liver transplant recipients with stable liver function.

Methods: In this study, investigators (7 transplant hepatologists) assessed clinical utility of the TruGraf Liver test in patient management. In a retrospective study, simultaneous blood tests and liver function tests (882 serial time points within the first year of liver transplant) were performed in 29 patients at 7 transplant centers.

Results: When queried regarding whether a single initial TruGraf Liver test result impacted their decision regarding patient management, in 455/882 (51.5%) of serial time points, the investigator responded in the affirmative. Of the 455 affirmative responses, nearly 70% were related to the test result supporting a decrease or increase in immunosuppressive therapy. Of the responses that TruGraf liver did not alter care, nearly 40% were related to the need to see the next serial test before modifying patient management. All seven providers (100%) stated the affirmative when asked if this blood test would be useful in general for future liver transplant patient management.