|[July 28, 2014]
Studies Presented at World Transplant Congress Support Development of Biomarker Tests Aimed at Improving Transplant Recipient Care
BROOKLINE, Mass. --(Business Wire)--
Studies by the founding scientists of Transplant Genomics Inc. (TGI) to
be presented this week at the World Transplant Congress (WTC) are
helping lay the groundwork for the company's development of genomic
biomarkers for transplant graft status. The studies are reflective of
the pipeline of clinical tests TGI will be commercializing as part of a
surveillance program to detect and respond to early signs of graft
injury to improve management of organ transplant recipients, with the
potential to extend lives and reduce costs of associated healthcare.
TGI's first test will be a blood test used to routinely monitor kidney
transplant recipients, indicating when treatment or biopsy is required.
"These studies have demonstrated the feasibility of our approach to
provide rich and objective diagnostic information," commented Stan Rose,
PhD, President & CEO of Transplant Genomics and a kidney transplant
recipient himself. "In the studies, peripheral blood gene expression
profiling demonstrated excellent potential as a noninvasive monitoring
tool that could enable differential diagnosis of graft status in kidney
and liver transplant recipients. The studies also indicate that
molecular profiling of tissue offers the potential to help clarify
ambiguous histological results."
Early Detection Can Make a Difference
An ongoing challenge in transplant treatment is subclinical acute kidney
rejection (SCAR), defined as histologic rejection even though the
patient's serum creatinine readings - a measure of kidney function - are
normal. SCAR is associated with worse long-term graft survival.
In Molecular Signature in the Peripheral Blood for Sub-clinical Acute
Kidney Rejection,1 to be presented by John Friedewald and
colleagues on Wednesday, July 30, 2014, the researchers showed that
peripheral blood gene expression profiling can correctly classify kidney
transplant patients with subclinical acute rejection, acute rejection
and transplant excellence.
"Peripheral blood gene expression profiling potentially provides a
viable method for detecting SCAR as part of a regular surveillance
program and for monitoring effectiveess of treatment," commented study
author John Friedewald, MD, Associate Professor of Medicine and Surgery
at Northwestern University's Feinberg School of Medicine and a
transplant nephrologist at Northwestern Memorial Hospital and the Kovler
Organ Transplant Center.
Gene Expression Profiling Can Be Powerful Molecular Classifier
Molecular Phenotyping of Kidney Biopsies by Global Gene Expression
Tightly Correlates with Histology Phenotypes and Long-term Outcomes,2
presented by Sunil Kurian and colleagues on Sunday, July 27, 2014,
compared gene expression profiling data from biopsy tissue against
biopsy results in 292 patients. The authors showed that gene expression
profiling has a predictive accuracy of 90-94% for acute rejection, acute
dysfunction no rejection, chronic allograft nephropathy and transplant
excellence samples, when compared to histology-documented phenotypes.
Discovery of Peripheral Blood and Biopsy-Based Molecular Classifiers
in Brazilian Kidney Transplant Patients,3 presented by
Carlucci Ventura, Sunil Kurian and colleagues on Sunday, July 27, 2014,
validated biopsy molecular phenotypes created with a US population in an
independent cohort of significantly different racial/ethnic backgrounds.
Predictive accuracies ranged from 87% to 94%. The researchers concluded
that there are strong unifying immune mechanisms driving transplant
disease and thus "international molecular diagnostics are feasible."
Gene Expression Profiling Can Distinguish Cause of Liver Rejection
Blood and Biopsy mRNA Expression Signatures Can Distinguish Major
Causes of Graft Injury in Liver Transplant Recipients,4
to be presented by Josh Levitsky and colleagues on Thursday, July 31,
2014, demonstrated that genomic signatures of specific types of liver
graft injuries can be identified from both blood and biopsy tissue. The
signatures are able to distinguish acute rejection in liver transplant
recipients from other major causes of graft injury, such as hepatitis C
virus recurrence (HCV-R) and alternative causes (acute dysfunction no
rejection/recurrence) with high predictive accuracy. These signatures
have the potential to enhance the specificity of diagnosis, particularly
in managing patients with contrasting etiologies (e.g., acute rejection
vs. HCV-R), determining pathophysiological mechanisms and informing
decisions to perform liver biopsies as well as immunosuppression
minimization and withdrawal.
About Transplant Genomics Inc.
Transplant Genomics Inc. (TGI) is a molecular diagnostics company
committed to improving organ transplant outcomes. Working with the
transplant community, TGI will deliver vital advances in diagnosis and
prediction of transplant status, supporting clinicians with clear,
actionable information to optimize immunosuppression therapy, enhance
patient care and improve graft survival. Tests will be made commercially
available through a CLIA lab, with an initial focus on kidney
1. Friedewald J, Kurian S, Levitsky J, et al. Molecular signature in the
peripheral blood for sub-clinical acute kidney rejection. Presentation
at World Transplant Congress, July 30, 2014.
2. Kurian SM, Modena B, Friedewald J, et al. Molecular phenotyping of
kidney biopsies by global gene expression tightly correlates with
histology phenotypes and long-term outcomes. Poster presentation A495 at
World Transplant Congress, July 27, 2014.
3. Ventura C, Kurian SM, Gelbart T, David-Neto E, Salomon DR. Discovery
of peripheral blood and biopsy-based molecular classifiers in Brazilian
kidney transplant patients. Poster presentation A523 at World Transplant
Congress, July 27, 2014.
4. Levitsky J, Salomon D, Kurian S, et al. Blood and biopsy mRNA
expression signatures can distinguish major causes of graft injury in
liver transplant recipients. Presentation at World Transplant Congress,
July 31, 2014.
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