CareDx Expands AlloSure Testing Services with Two New Indications
CareDx, Inc. (Nasdaq: CDNA), known as The Transplant Company™, a leader in precision medicine focused on the discovery, development, and commercialization of advanced healthcare solutions for transplant patients, has announced the expansion of its AlloSure® testing services. AlloSure® is now commercially available for pediatric heart transplant patients of all ages and those who have undergone a simultaneous pancreas-kidney (SPK) transplant. This expansion broadens the reach of AlloSure® to support more transplant patients, improving the management and care of these critical populations.
CareDx, Inc. (Nasdaq: CDNA), a leader in precision medicine for transplant patients, has expanded its AlloSure® testing services to include two new indications. AlloSure is now commercially available for pediatric heart transplant patients of all ages and for patients who have received a simultaneous pancreas-kidney (SPK) transplant. These new indications, approved by the New York State Clinical Laboratory Evaluation Program, highlight AlloSure’s ability to meet the highest validation standards for laboratory-developed tests (LDTs).
AlloSure Heart, which has been available for patients aged 15 and older since 2020, is now clinically validated for use in pediatric heart transplant patients under 15, including infants. This testing method has demonstrated its ability to detect biopsy-proven Acute Cellular Rejection (ACR) and Antibody-Mediated Rejection (AMR) across all age groups, including pediatric heart transplant patients. In studies, AlloSure Heart has shown a significant ability to monitor rejection and organ health without the need for invasive biopsies. A prospective study on pediatric patients demonstrated an 81% reduction in surveillance endomyocardial biopsies (EMBs), making it a vital tool in reducing the discomfort and risk of unnecessary procedures for children undergoing heart transplantation.
Dr. Brian Feingold, Medical Director of Pediatric Heart Transplantation at UPMC Children’s Hospital of Pittsburgh, emphasized the importance of this advancement. “The availability of AlloSure dd-cfDNA for all pediatric heart transplant patients is a major development. Our goal is for every one of our patients, including our youngest heart transplant recipients, to thrive with their transplanted heart. With molecular surveillance, we can monitor organ health while avoiding the inconvenience and discomfort of unnecessary biopsies,” said Dr. Feingold. He added, “We consider the use of surveillance biopsies outside of the first 2 or 3 months after transplantation to be outdated now that AlloSure is available for every pediatric heart transplant recipient.”
Simultaneous pancreas-kidney (SPK) transplants, which are commonly performed in patients with insulin-dependent diabetes and advanced renal disease, improve both quality of life and long-term survival. However, these organs are still at risk of rejection. AlloSure Kidney, which has already been clinically validated to identify rejection and graft injury in kidney transplant patients, is now available for SPK patients. By differentiating patients at higher risk of rejection, AlloSure Kidney helps in identifying those who may require additional monitoring from those who are at lower risk. This tool allows healthcare providers to better manage SPK patients by offering a non-invasive method of monitoring organ health.
Dr. Dolamu Olaitan, Transplant Surgeon at Rush University Medical Center, spoke to the significance of this development for SPK patients. “It is an honor to have led some of the early studies and to see that AlloSure Kidney is now clinically validated and commercially available for use in patients who have undergone simultaneous pancreas-kidney transplantation,” said Dr. Olaitan. “I have witnessed firsthand the significant benefits for patients with diabetes and kidney failure of receiving a pancreas and kidney transplant. Now, we have a well-validated, non-invasive tool to monitor organ rejection and injury, which has the potential to improve their quality of life and long-term outcomes.”
CareDx is proud to introduce these expanded indications for AlloSure, meeting critical needs in transplant patient care. Until now, pediatric heart transplant patients under 15 could only be tested on an exceptional basis. With AlloSure Heart now available for routine use in this population, healthcare providers can offer more consistent and effective monitoring. Additionally, AlloSure Kidney offers a reliable solution for SPK transplant patients, providing a non-invasive means of detecting rejection and improving patient management.
Robert N. Woodward, Chief Scientific Officer at CareDx, expressed excitement about the launch. “We are thrilled to introduce two new expanded indications of AlloSure, addressing critical needs in transplant patient care. Until now, children under 15 who received a heart transplant could only be tested by exception, but now they can receive routine AlloSure Heart testing. Additionally, for patients who have undergone a simultaneous pancreas-kidney transplant, we have a solution to meet their needs,” said Woodward.
In 2024, over 4,500 heart transplants were performed in the U.S., with approximately 10% of those involving pediatric patients under the age of 18. Additionally, more than 700 patients received an SPK transplant during the same year. With the new indications for AlloSure, CareDx continues to expand its support for transplant patients, improving outcomes and reducing unnecessary procedures.
About CareDx – The Transplant Company
CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine company focused on providing high-value healthcare solutions for transplant patients. CareDx offers a comprehensive range of testing services, products, and digital healthcare solutions throughout the pre- and post-transplant journey. As the leading provider of genomics-based information for transplant patients, CareDx is committed to improving patient care by providing tailored, innovative tools to ensure better transplant outcomes.
