Natera, Inc. 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. 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.

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 patients 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. The Trifecta-Heart study had its initial publication last week in Transplantation and has an upcoming oral presentation at the 2024 International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting. This initial readout included 137 plasma samples analyzed using the Prospera Heart test, correlated with matched EBs analyzed using the Molecular Microscope®?

Diagnostic System (MMDx), a more objective reference standard for rejection compared to histopathology.