Transplantation Technologies & Research

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.

With over a hundred thousand transplants needed every year and limited availability leading to the death of 20 patients each day, long term viability of solid organ transplants is imperative. Early allograft transplant rejection is well controlled by immunosuppression of T cells, but late organ loss due to allograft vascular (AV) disease and chronic immune damage are unmet medical needs. Chronic AV disease and ongoing immune damage are leading causes of late transplant organ loss. In prior work, we demonstrated that implant of an allograft kidney with a conditional deficiency of the N-deacetylase N-sulfotransferase 1 (Ndst1^-/-) enzyme in the endothelium and myeloid precursors (C57Bl/6 background) led to a significant decrease in early rejection after implant into wild type BALB/c mice with normal Ndst1 expression.