How to Interpret Transplant Genomics Tests
Transplant Genomics’ innovative tests present a novel avenue for detecting subclinical organ transplant rejection. Our tests enable the identification of rejection at its earliest stages, offering an alternative to invasive biopsies.
By analyzing specific genetic markers and patterns, Transplant Genomics’ tests provide clinicians with a proactive tool to monitor the health of transplanted organs and make informed decisions regarding patient care. This advanced approach enhances the potential for successful transplant outcomes and ultimately contributes to the overall well-being of transplant recipients.
Overview of Genomic Testing
The genome is the complete set of DNA that carries the genetic information required for the development, function, and maintenance of an organism. Genomics is the study of the genome. It involves analyzing and understanding the structure, function, evolution, and interaction of all the genes.
Transplant Genomics leverages expertise in this field to provide precision medical diagnostics to help guide patient management following transplant.
TruGraf® Kidney
The first gene expression profile test developed specifically for renal transplant recipients with focus on surveillance for patients with healthy, stable graft function. TruGraf® Kidney assesses differentially expressed genes in the blood to rule out unnoticed, early-stage organ rejection, pinpointing patients who are likely appropriately immunosuppressed.
TruGraf® Kidney uses microfluidic PCR technology to compare gene expression profiles against a reference population to classify results as Transplant eXcellence (TX), negative for subclinical rejection and likely adequately immunosuppressed, or Not Transplant eXcellence (not-TX), positive for subclinical rejection and likely inadequately immunosuppressed.
TRAC Kidney
The Viracor TRAC® Kidney donor-derived cell-free DNA (dd-cfDNA) assay offers a noninvasive approach to monitoring transplant recipients post-transplant. This blood test utilizes next-generation sequencing (NGS) to analyze the percentage of dd-cfDNA in the recipient’s plasma. By employing advanced technology, this assay allows healthcare providers to identify potential instances of solid organ transplant rejection. The use of noninvasive methods is crucial, providing essential information that can be valuable in diagnosing solid organ transplant rejection.
OmniGraf Liver
OmniGraf® Liver is the first and only blood-based test that provides biomarker guidance to assist physicians in optimizing immunosuppression for liver transplant recipients. It enables a superior balance between graft rejection and adverse events. OmniGraf® Liver can assist clinicians in confirming immune quiescence during the optimization of immunosuppression in patients with stable graft function, thereby minimizing the risk of overt graft injury due to rejection.
Interpreting Gene Expression Results
TruGraf® Kidney
Discriminate between allografts that are truly healthy and those in transplant patients that are experiencing subclinical rejection (also referred to as silent rejection), often with no other suspicion of rejection.
Results are binary, either TX (Transplant eXcellence, or negative for subclinical rejection) and not-TX (not Transplant eXcellence, or positive for subclinical rejection).
OmniGraf® Liver
Determine the immune status for a patient based on a dynamic risk score. If the patient is below the threshold of 50, they are at a lowered risk for rejection. If they are at or above the threshold of 50, it indicates there is a higher risk for rejection.
The figure above is a heat map representation of gene expression levels (red = high; blue = low) from 1,000 genes in 350 kidney biopsy samples from patients classified into diagnostic categories based on conventional histological analysis. The molecular phenotypes displayed show a strong correlation to graft status and complement the histological analysis, resolving ambiguous or borderline results.
Molecular signatures for each diagnostic category were discovered through an unbiased approach involving global gene expression studies. More than 2,000 genes (including cellular receptors, cytokines, and signaling molecules) were discovered to be differentially expressed in kidney biopsies and mapped back to over 60 distinct immunological pathways. The 120 genes with the highest discriminatory power between the non-TX and TX phenotypes are the IP incorporated in TruGraf Kidney.
Medical professionals may use TruGraf tests to:
- Monitor renal transplant recipients to detect “silent” subclinical acute rejection
- Inform when to perform for-cause biopsies, rather than relying on protocols or other lagging indicators of injury
- Optimize minimization of immunosuppression therapy by ensuring early detection of an immune response
- Profile biopsies to complement conventional histology and help resolve ambiguous or borderline cases.
Learn More
Learn more about Eurofins Transplant Genomics and our tests for detecting subclinical organ transplant rejection in our News and Resources Center
For questions about our testing services, contact us today.