Natera, Inc. announced the results of its DEFINE-HT clinical trial in heart transplantation, presented at the International Society for Heart and Lung Transplantation 45th Annual Meeting. The study demonstrated that Prospera Heart with Donor Quantity Score (DQS) is predictive of clinical outcomes.
DEFINE-HT is the first prospective, multicenter study in heart transplant recipients designed to assess whether elevated levels of donor-derived cell-free DNA (dd-cfDNA) are associated with adverse clinical outcomes. The study, which included over 1,100 dd-cfDNA samples, showed a significant correlation between dd-cfDNA and a composite endpoint of treated rejections, graft dysfunctions, re-transplantations, and deaths at one year.
Crucially, Prospera Heart with DQS outperformed biopsy in predicting graft dysfunction, demonstrating a 37% reduction in false positives and being three times better at predicting graft dysfunction. These findings suggest the potential for Prospera to obviate invasive surveillance endomyocardial biopsies, leading to less invasive and more personalized patient management.
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