07-05-2025
Prospera™ Heart Test with DQS Outperforms dd-cfDNA Percentage in Detecting Allograft Rejection, New AJT Publication Shows
Study published in American Journal of Transplantation highlights strong sensitivity and specificity, along with a >37% reduction in false positives when using Prospera Heart with DQS
Adds to the growing body of evidence supporting DQS for dd-cfDNA analysis in solid organ transplant
AUSTIN, Texas, May 07, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that the American Journal of Transplantation (AJT) published a new study1 evaluating the performance of Prospera Heart with DQS to detect allograft rejection.
Prospera with DQS leverages a two-threshold algorithm, combining the traditional donor fraction (dd-cfDNA %, measuring dd-cfDNA as a fraction of total cfDNA) and donor quantity score (DQS, estimating the total quantity of dd-cfDNA in the blood). This method delivers a single result for risk assessment of both antibody mediated rejection (AMR) and acute cellular rejection (ACR).
In the study, 808 Prospera Heart test samples were obtained from 187 heart transplant patients alongside paired endomyocardial biopsies. Prospera with DQS was compared to dd-cfDNA %-alone to assess the detection of biopsy-proven allograft rejection. The study highlights the following performance improvements demonstrated by Prospera with DQS, including:
Sensitivity increased from 78.2% to 86.5%.
Specificity increased from 76.9% to 83.6%.
Area under the curve (AUC) increased from 0.865 to 0.881
A reduction in false positive cases of 37.3%
"This publication provides evidence that combining dd-cfDNA % with DQS improves the accuracy of dd-cfDNA testing for acute rejection over dd-cfDNA %-alone," said Josef Stehlik, M.D., M.P.H., one of the study investigators and medical director of the Heart Transplant Program and co-chief of the Advanced Heart Failure Program at the University of Utah. "It is encouraging to see that this novel approach significantly reduced false positive results and will help to obviate unnecessary biopsies in clinical care. This is another step in providing enhanced care for heart transplant patients using noninvasive tools to determine risk of rejection."
This data confirms the growing body of evidence for the utilization of DQS when analyzing dd-cfDNA in solid organ transplant, including a study evaluating DQS in kidney transplant (Halloran et al). Natera has also demonstrated the value of DQS in the supplemental data from its 2022 DEDUCE study2 in Prospera Heart, as well as recently announced data from the DEFINE-HT study.
