cross-section of kidneys with arteries and veins

Biomarker Science for Kidney Transplant Monitoring

Kidney transplantation can be life-saving, but the risk of rejection is a constant concern for patients and healthcare providers alike. Long-term outcomes of transplanted organs have improved only minimally over the past two decades relative to the dramatic improvements with outstanding patient and graft survival at one year, and infrequent episodes of acute cellular rejection at one year. Poor monitoring, injury prediction, and detection are challenges that must be overcome to ensure the best possible outcomes for transplant recipients. 

Biomarkers like gene expression profiling and donor-derived cell-free DNA (dd-cfDNA) have emerged as an invaluable diagnostic tools for transplant monitoring, providing clinicians with an accurate and non-invasive method to detect and predict rejection. We’re proud to be at the forefront of this exciting field, developing innovative biomarker tests like TruGraf® Kidney and Eurofins TRAC® Kidney that are revolutionizing the way transplant patients are monitored.

Breakthrough Science:

Biomarkers Improve Kidney Transplant Outcomes

Gene Expression Profiling

Gene expression profiling is a powerful tool used in kidney transplant diagnostics. It provides a comprehensive analysis of the activity of genes involved in the immune response, which can help detect and monitor potential signs of rejection. 

Gene expression refers to the process by which the genetic information stored in DNA is converted into functional proteins that carry out specific cellular functions. The expression of certain genes can be upregulated or downregulated in response to external stimuli, such as injury or infection, to enable appropriate responses by the body’s cells. By identifying the specific genes that are activated or suppressed during the rejection process, clinicians can make more informed decisions about therapy optimization and improve patient outcomes.

Donor-Derived Cell-Free DNA

Donor-derived cell-free DNA (dd-cfDNA) is another powerful biomarker that can be used to monitor transplant health. When a transplant is performed, the transplanted organ contains cells from the donor, which can release fragments of DNA into the recipient’s bloodstream. By measuring the levels of dd-cfDNA in a patient’s blood, clinicians can detect early signs of organ injury and monitor the effectiveness of treatment over time.

Donor-derived cell-free DNA (dd-cfDNA) refers to the fragments of DNA from the transplanted donor that circulate in the recipient’s bloodstream. These fragments are released into the bloodstream as a result of normal cellular turnover and cell death in the transplanted organ, and they can be detected in the recipient’s blood. Monitoring dd-cfDNA levels can help detect early signs of organ rejection or damage, and can guide decisions about treatment and follow-up care. Additionally, dd-cfDNA testing can help distinguish between rejection and other potential causes of organ dysfunction, such as infection or drug toxicity.

Biomarkers are a Vital Tool for Personalized Post-Transplant Care

Biomarker science is changing the way we approach post-transplant care for kidney transplant recipients. Traditional diagnostic methods are lagging indicators of rejection, often requiring invasive biopsies that can be limited in scope and frequency. Biomarkers provide a more comprehensive, non-invasive view of the health of a transplanted kidney, allowing for earlier detection of potential problems before they become severe.

nephrologist laughing with his elderly patient

The evolution of standard of care for kidney transplant recipients 

Surveillance biopsy 

Surveillance biopsies are usually recommended for patients who have recently undergone a kidney transplant, as well as those who are at a higher risk of complications due to factors such as age, previous transplant failures, or pre-existing medical conditions.  By identifying potential issues early on, clinicians can take steps to prevent further damage to the transplanted kidney and ensure that the patient receives the appropriate treatment. Although kidney surveillance biopsy is generally considered a safe procedure, there is a small risk of complications, such as bleeding, infection, or damage to nearby organs.

Indicators of injury

  • Serum Creatinine 
  • Proteinuria
  • Estimated glomerular filtration rate (EGFR) 

Our Biomarker Tests that are Revolutionizing Kidney Transplant Monitoring

At Eurofins Transplant Genomics, we’re committed to improving the outcomes of kidney transplants. That’s why we’ve developed two cutting-edge tests that leverage the power of gene expression profiling and dd-cfDNA biomarkers to help healthcare providers monitor and optimize transplant outcomes.

TruGraf® Kidney:

A gene expression profiling assay for ruling out “silent” rejection

TruGraf Kidney is the first and only non-invasive biomarker test approved for coverage and  validated for surveillance of stable kidney transplant recipients. With TruGraf Kidney, clinicians can rule out “silent” rejection early, allowing them to intervene before it becomes a more serious problem. Click here to learn more about how TruGraf Kidney can help you monitor kidney transplant health.

Eurofins TRAC® Kidney:

A donor-derived cell-free DNA assay for evaluating acute allograft rejection

The Eurofins TRAC (Transplant Rejection Allograft Check) donor-derived cell-free DNA assay is designed to utilize a noninvasive liquid biopsy to monitor the percentage of dd-cfDNA in transplant recipient plasma post-transplant using next generation sequencing (NGS). It utilizes a bioinformatics pipeline that analyzes NGS and genome-wide recipient genotype data to determine the percentage of dd-cfDNA present, which strongly correlates with allograft injury due to rejection. The licensed algorithm accurately quantifies the donor-derived fraction of cell-free DNA without need for donor genotype information, even when the donor is closely related (e.g., sibling kidney donors).