Transplant Genomics. Inc. (TGI), has obtained an exclusive license to patent rights co-owned by The Scripps Research Institute (TSRI) and Northwestern University that provide the foundation for clinical tests to improve management of organ transplant recipients, with the potential to extend lives and reduce costs of associated healthcare. TGI intends to develop and commercialize tests that use genomic markers of transplant graft status as part of a surveillance program to detect and respond to early signs of graft injury.
TGI’s first test will be used to routinely monitor kidney transplant recipients, indicating when treatment or biopsy is required based on analysis of a patient’s blood. As described in a study involving seven transplant centers recently published in the American Journal of Transplantation, peripheral blood gene expression profiling was used to classify kidney graft recipients into three key categories of graft status (acute rejection, acute dysfunction/no rejection, and stable graft performance) with very high predictive accuracy. Ongoing prospective studies will reveal how far in advance of dysfunction these signatures can be detected, and whether they can be used to monitor the effectiveness of treatment. The need for such improved tests is highlighted by the fact that more than 15% of kidney transplant patients with normal serum creatinine levels, the most commonly used indicator of graft injury, show signs of rejection when their grafts are analyzed by protocol biopsy up to one year post-transplant.
“The danger of subclinical acute organ rejection is well recognized as a significant cause of late graft loss but nearly impossible to diagnose since doing serial biopsies is not feasible,” explains Dan Salomon, MD, of TSRI. “A minimally invasive blood test could be used to predict clinical rejection, to diagnose subclinical rejection, and to monitor treatment to assure clinicians that the therapy was fully effective. Read more about TGI and improving transplant outcome.
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