Natera Announces New Data From Two Studies Extending the Clinical Validation of Its Prospera Heart dd-cfDNA Test for Heart Transplant Recipients

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced the publication of two major studies, DTRT-2 and Trifecta-Heart, showcasing the ability of the Prospera Heart donor-derived cfDNA (dd-cfDNA) test to detect rejection in adult and pediatric heart transplant recipients. These are the second and third peer-reviewed publications evaluating Natera’s technology for use in heart transplantation.

“We are encouraged by the results of these two prospective studies,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera. “The consistent, excellent performance of Prospera Heart across multiple independent studies should inspire confidence among transplant physicians to leverage Prospera as part of standard patient care.”

The Prospera Heart test was launched in 2021 and received Medicare coverage following the 2022 publication of a multi-site clinical validation study, the DEDUCE study, in the Journal of Heart and Lung Transplantation. That study showed the Prospera Heart test had an overall area under the curve (AUC) of 0.86 for identifying acute rejection in over 800 samples from 200 adults with heart transplants.

The DTRT-2 (DNA-Based Transplant Rejection Test) study, published recently in Pediatric Transplantation, was sponsored by the National Institutes of Health (NIH). A total of 487 samples from 160 heart transplant recipients were evaluated, of which 78 were pediatric and 82 were adult patients. The Prospera Heart test demonstrated outstanding performance in detecting rejection, as determined by histopathology from endomyocardial biopsies (EMBs), with an AUC of 0.82 in adult patients and 0.83 in pediatric patients. The study reported a negative predictive value (NPV) of 92% for adult patients and 99% for pediatric patients, supporting the intended use of Prospera Heart as a rule-out test to help obviate surveillance biopsy procedures.

“DTRT-2 is a landmark study that further demonstrates that the Prospera Heart test is a highly reliable, non-invasive tool for detecting heart transplant rejection in adult patients, and now solidifies that outstanding performance for pediatric patients as well,” said Shriprasad R. Deshpande, MBBS, MS, director of the Advanced Cardiac on Therapies and Heart Transplant Program, Children’s National Hospital, and lead author of the study. “Based on these findings, I believe the Prospera Heart test has the potential to greatly reduce the number of invasive surveillance biopsies in children and enhance their quality of life.”