Transplant Genomics Inc (TGI) has obtained an exclusive license to patent rights co-owned by Northwestern University and the Scripps Research Institute that provide the foundation for clinical tests to improve the management of organ transplant recipients, with the potential to extend lives and reduce costs of associated healthcare.
TGI is a molecular diagnostics company that 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. Tests will be made commercially available through a CLIA lab, with an initial focus on kidney transplantation.
The licensing agreement provides TGI with access to a broad portfolio of intellectual property related to kidney and liver transplant diagnostics, including immune status monitoring and optimization.
TGI’s scientific founders are Michael M. I. Abecassis, MD, MBA, founding director of the comprehensive transplant center and chief of the division of surgery–organ transplantation at the Northwestern University Feinberg School of Medicine; and Daniel R. Salomon, MD, director of the laboratory for functional genomics and medical program director of the center for organ and cell transplantation at the Scripps Research Institute. Each has been recognized for his work on the discovery and validation of novel biomarkers of graft and immune status for solid-organ transplants.
“The scientific founders of TGI have uniquely combined biomarker discovery with clinical validation and insight to set the stage for high-impact collaborations designed to move the transplant field forward,” explained Stanley Rose, PhD, president and CEO of TGI, and himself a kidney transplant recipient. “Working with the transplant community, TGI will bring these vital advances in biomarkers of transplant status from bench to clinic. Clinicians will be able to access clear, actionable information to optimize immunosuppression therapy, and improve graft survival.”
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.1 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.2-4
“TGI’s tests could be used for serial patient monitoring in stable patients with good kidney function to better inform decisions about immunosuppression,” said Abecassis. “The test will also find a major and immediate application in circumstances where a sudden elevation in creatinine is noted by the clinician and a biopsy is not possible because of logistical issues.”
“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,” explained Salomon. “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.”
For more information, visit Transplant Genomics Inc.
1. Kurian SM, Williams AN, Gelbart T, et al. Molecular classifiers for acute kidney transplant rejection in peripheral blood by whole-genome gene expression profiling. Am J Transplant. 2014;5(14):1164–1172.
2. Rush D, Somorjai R, Deslauriers R, et al. Subclinical rejection—a potential surrogate marker for chronic rejection—may be diagnosed by protocol biopsy or urine spectroscopy. Ann Transplant. 2000;5(2):44–49.
3. Moreso F, Ibernon M, Goma M, et al. Subclinical rejection associated with chronic allograft nephropathy in protocol biopsies as a risk factor for late graft loss. Am J Transplant. 2006;6(4):747–752.
4. Nankivell BJ. Subclinical renal allograft rejection and protocol biopsies: quo vadis? Nat Clin Pract Nephrol. 2008;4(3):134–135.