Kidney Graft Quality Assessment via Cell-free DNA Quantification in Hypothermic Machine Perfusate

Provides Physicians with a Repeatable and Standardized Approach to Assessing Transplant Quality

This prognostic marker assesses kidney graft quality to provide insights into preservation and post-transplant organ function. Cell-free DNA concentration in kidney allograft perfusate serves as a rapid biomarker that can be used alongside hypothermic machine perfusion. Kidney transplants are among the most common transplant surgeries in the United States. In 2023, about 28,000 patients received kidney transplants, and more than 35,000 patients were awaiting a transplant1. To support transplant procedures, organ preservation technology and solutions are crucial, with the industry valued at $315.59 million in 2023 and projected to grow to $605.14 million globally by 20332. Hypothermic machine perfusion is the standard of care for preserving kidney viability. During organ preservation, inevitable damage and injury occur to the allograft, making it essential to establish a standardized and repeatable approach for assessing graft attributes and tissue damage to evaluate graft quality and predict post-transplant function.

Researchers at the University of Florida have developed a method to quantify cell-free DNA in hypothermic perfused kidney grafts. This method offers a standardized and repeatable measure of organ quality. This breakthrough provides enhanced insights as a prognostic marker throughout the transplantation process.

Application

Standardized, repeatable, and non-invasive assessment of kidney graft preservation quality for intraoperative and postoperative renal function information

Advantages

• The measurement of cfDNA in perfusate is noninvasive and does not rely on donor-specific factors, providing a standardized approach applicable to all patients
• Repeatable and standardized assessment, offering continuous insights to guide physicians in determining kidney graft quality
• Uses widely available DNA measurement assays, such as digital PCR, spectrophotometric, or fluorometric techniques, enabling rapid analysis without the need for sequencing

Technology

Kidney grafts undergo hypothermic machine perfusion for organ preservation. Hypothermic machine perfusion is a process that maintains organ viability and reduces the risk of delayed graft function. However, allografts inevitably accrue injury during this period. Cell-free DNA, derived from the gradual cell death of allograft tissue, serves as a proxy for tissue damage. Sampling the organ perfusate during HMP can provide a reliable measure of kidney transplant quality. Kidney graft quality assessment is performed by sampling the organ perfusate during hypothermic machine perfusion. From the acquired sample, researchers extract soluble DNA and quantify its concentration based on relevant values. The soluble DNA circulating in the perfusate is derived from the gradual cell death of the allograft tissue. Quantification methods for soluble DNA rely on digital PCR, spectrophotometric, or fluorometric techniques. The quantification of soluble DNA in hypothermic machine perfusion perfusate is a reliable method for assessing kidney transplant quality, providing the ability to continuously monitor graft quality. This method offers a dynamic and non-invasive method to predict post-transplant outcomes, ultimately improving transplant success rates and patient outcomes.