First Molecular Test Launched to Monitor Kidney Transplant Rejection

Quest Diagnostics announced yesterday the availability of the industry’s first molecular blood test for identifying renal (kidney) organ-transplant rejection. The test is designed to help clinicians detect kidney failure weeks earlier than conventional tests, potentially improving patient care for transplant patients and lowering healthcare costs.

Standard post-transplant monitoring involves lab testing of serum creatinine, a renal function marker, and renal biopsy. The new molecular test is based on RNA genetic markers including forkhead box P3 (FoxP3), granzyme B (GZMB), and perforin (PRF1), licensed exclusively from Boston-based Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard Medical School, and New York City-based Weill Cornell Medical College, the medical school of Cornell University.

Studies published by the New England Journal of Medicine, Journal of Transplantation and other peer-reviewed journals demonstrate that blood level elevations of biomarkers in the Quest Diagnostics' test are associated with renal transplant rejection and often occur before a rise in blood levels of serum creatinine. Earlier detection of transplant rejection may spur interventions that help to improve the likelihood of graft survival.

"Molecular diagnostics to noninvasively detect and predict renal-transplant rejection and monitor the efficacy and safety of pharmaceutical drug therapy and treatment withdrawal have the potential to significantly improve treatment and outcomes for renal transplant patients," said Terry Strom, M.D., professor of medicine, Harvard Medical School, and co-director, The Transplant Institute at BIDMC. "The first molecular test for this purpose has opened the window to new opportunities for personalized and more effective management of renal graft patients."

"Organ transplant failure not only affects patient outcomes and quality of life, it also drives up healthcare costs," said Stanley J. Naides, M.D, medical director, Immunology, Quest Diagnostics. "Quest Diagnostics' new renal monitoring test is an important medical innovation because it has the potential to improve patients' lives while also helping to reduce the significant expense of failed kidney transplants."