CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on transplant care, has announced the commercial availability of its AlloSure testing service for two new patient populations: pediatric heart transplant recipients of all ages and patients who have received simultaneous pancreas-kidney (SPK) transplants.
Both expanded indications have received approval from the New York State Clinical Laboratory Evaluation Program, which represents one of the most rigorous validation standards for laboratory developed tests in the United States.
Expanded Access for Pediatric Heart Transplant Patients
AlloSure Heart, which has been available for patients 15 years and older since 2020, is now clinically validated and commercially available for pediatric patients under 15, including infants. Clinical studies have demonstrated that AlloSure Heart can effectively detect both Acute Cellular Rejection (ACR) and Antibody Mediated Rejection (AMR) in pediatric heart transplant patients of all ages, with performance consistent with results seen in adults.
A prospective study showed that using AlloSure's donor-derived cell-free DNA (dd-cfDNA) for surveillance monitoring in pediatric patients resulted in an 81% reduction in surveillance endomyocardial biopsies (EMB), significantly reducing the need for invasive procedures.
Dr. Brian Feingold, Medical Director of Pediatric Heart Transplantation at UPMC Children's Hospital of Pittsburgh, emphasized the significance of this development: "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."
Dr. Feingold added that his team now considers surveillance biopsies outside of the first 2-3 months after transplantation to be outdated given the availability of AlloSure for all pediatric heart transplant recipients.
New Option for Simultaneous Pancreas-Kidney Transplant Patients
The second expanded indication addresses the needs of patients who have received simultaneous pancreas-kidney (SPK) transplants, a procedure known to improve quality of life and long-term survival for patients with insulin-dependent diabetes and advanced renal disease.
AlloSure Kidney has been clinically validated to identify rejection and graft injury specifically in SPK patients. The non-invasive test can help clinicians differentiate between patients at increased risk of rejection who appear otherwise stable from those with a low likelihood of rejection.
Dr. Dolamu Olaitan, MBBS, Transplant Surgeon at Rush University Medical Center, who led some of the early studies on AlloSure Kidney in SPK patients, commented: "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."
Addressing Critical Needs in Transplant Care
Robert N. Woodward, CareDx Chief Scientific Officer, highlighted the importance of these expanded indications: "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."
According to data from the Organ Procurement and Transplantation Network (OPTN), over 4,500 heart transplants were performed in the U.S. in 2024, with approximately 10 percent (450) in patients under the age of 18. Additionally, more than 700 patients received SPK transplants in 2024.
Clinical Significance and Future Implications
The expansion of AlloSure testing to these patient populations represents a significant advancement in transplant care. For pediatric heart transplant patients, the ability to monitor for rejection without frequent invasive biopsies could substantially improve quality of life and potentially reduce complications associated with biopsy procedures.
Similarly, for SPK transplant recipients, having a validated non-invasive monitoring tool could lead to earlier detection of rejection, potentially improving graft survival rates and long-term outcomes.
CareDx's continued expansion of its testing services aligns with the growing trend toward precision medicine in transplant care, where monitoring solutions are increasingly tailored to specific patient populations and transplant types.
The company continues to focus on developing and commercializing clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, offering testing services, products, and digital healthcare solutions throughout the pre- and post-transplant patient journey.
