Non-Invasive Assay Measuring Donor-Derived Cell-Free DNA (dd-cfDNA) Levels May Improve Surveillance of Heart & Other Solid-Organ Transplants; Assay Could Enable Early Detection of Rejection & Monitoring of Anti-Rejection Treatment Progress

Patients who have received a solid organ transplant require lifelong immunosuppressive therapy. The threat of transplant rejection due to insufficient drug therapy must be balanced against increased risks of infections and cancer from excessive immunosuppression. A significant unmet need exists for non-invasive diagnostic tools to monitor transplant recipients, especially for early detection of active injury and rejection. A report published online on October 7, 2016 in The Journal of Molecular Diagnostics describes validation of a clinical-grade non-invasive test that measures donor-derived cell-free DNA (dd-cfDNA) in plasma that has the potential to reduce complications and rejection, improving outcomes in transplant recipients. The open-access Journal of Molecular Diagnostics article is titled “Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients.” “dd-cfDNA is an emerging biomarker of transplanted organ injury, and the availability of a clinical-grade, analytically validated assay is critical for advancement of this biomarker toward improving the outcomes of transplant patients,” explained lead investigator Marica Grskovic, Ph.D., Associate Director, R&D, CareDx, Inc. (Brisbane, California). Plasma cfDNA has been proposed as a biomarker for prenatal testing, cancer, and organ transplantation. Taking advantage of genetic differences between a transplant donor and recipient, techniques have been developed to measure levels of a donor’s DNA in the recipient’s plasma, serum, or urine as a way to monitor the health of transplanted tissue, whether from the heart, lungs, liver, kidney, or other organs. Although dd-cfDNA assays for research have been described previously, this constitutes the first time a clinical-grade assay has been reported.
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