The Current Approach
The state of the art for monitoring kidney graft status has not changed in over two decades. Serum creatinine, the current standard, is an insensitive, late-trailing indicator of graft function. When creatinine levels are elevated, biopsies are generally performed to assess whether graft function has been compromised and, if so, identify the cause through histological analysis. Biopsies are costly, disruptive, subjective and invasive. They carry the risk of complications and, as much as one third of the time, fail to yield useful, actionable information.
A New Direction
Leveraging more than a decade of work by our scientific founders and >$25M in ongoing NIH funding, TGI has developed tests to detect impaired kidney graft function earlier, pinpoint the cause and guide personalized intervention. Our nonbiased approach to test development uses a broad range of genomic and proteomic tools capable of revealing the complexity of the underlying biology, which is well known to be highly heterogeneous. Compared to current methods, our tests will enable earlier detection of graft dysfunction and differential diagnosis among actionable causes, providing an opportunity for physicians to take clinical actions to prolong graft and patient survival.
Our tests can be used, for example, in monitoring patients to detect subclinical rejection, informing when to perform biopsies rather than relying on protocols or waiting for creatinine levels to rise; for optimizing minimization of immunosuppression therapy by ensuring early detection of an immune response; and in molecular profiling of biopsies to complement conventional histology and help resolve ambiguous or borderline cases.