CareDx, Inc. The Transplant Company announced that AlloSure is now commercially available for pediatric heart transplant patients of all ages and patients who have received a simultaneous pancreas-kidney (SPK) transplant.
Both indications are approved by the New York State Clinical Laboratory Evaluation Program, demonstrating that AlloSure has met the most rigorous validation standards for laboratory developed tests (LDTs).
AlloSure Heart, available for patients aged 15 years and older since 2020, is now clinically validated and commercially available for use in pediatric patients under 15, including infants. Studies have shown that AlloSure Heart can detect biopsy proven Acute Cellular Rejection (ACR) and AMR (Antibody Mediated Rejection) in all ages of pediatric heart transplant patients, consistent with its performance in adults.1-4 In a prospective study, the use of AlloSure dd-cfDNA for surveillance monitoring in pediatrics demonstrated an 81% reduction in surveillance endomyocardial biopsies (EMB).1
AlloSure Kidney has been clinically validated to identify rejection and graft injury in SPK patients.5-6 AlloSure Kidney can improve the management of SPK patients by differentiating those at increased risk of rejection, who are otherwise stable, from patients at low likelihood of rejection.
References
- Feingold B, Rose-Felker K, West SC, et al. Early findings after integration of donor-derived cell-free DNA into clinical care following pediatric heart transplantation. Pediatr Transplant. 2022;26(1):e14124. doi:10.1111/petr.14124.
- O'Halloran CP, Tannous P, Arva NC, et al. Histopathology, mRNA expression profile, and donor-derived cell-free DNA for assessment of rejection in pediatric heart transplantation. Pediatr Transplant. 2024;28(3):e14705. doi:10.1111/petr.14705.
- Akabas L, Bravo SA, Zhang Y, et al. Progress in Noninvasive Surveillance for Acute Rejection in Pediatric Heart Transplant Recipients: A Real-World Analysis of Donor-Derived Cell-Free DNA-Based Surveillance Protocol. Clin Transplant. 2024;38(10):e15481. doi:10.1111/ctr.15481.
- Feingold B, Rose-Felker K, West SC, et al. Short-term clinical outcomes and predicted cost savings of dd-cfDNA-led surveillance after pediatric heart transplantation. Clin Transplant. 2023;37(5):e14933. doi:10.1111/ctr.14933.
- Yoo A, Riedel A, Qian I, et al. An Initial Analysis of the Baseline Levels of Dd-cfDNA After Pancreas Transplantation: A Prospective Study From High-volume Centers in the United States. Transplant Direct. 2023;9(4):e1459. doi:10.1097/TXD.0000000000001459.
- Williams MD, Fei M, Schadde E, et al. Early Experience Using Donor-derived Cell-free DNA for Surveillance of Rejection Following Simultaneous Pancreas and Kidney Transplantation. Transplant Direct. 2022;8(5):e1321. doi:10.1097/TXD.0000000000001321.
