CareDx Inc ((CDNA)) announced an update on their ongoing clinical study.
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CareDx Inc. is conducting an observational study titled ‘Surveillance HeartCare® Outcomes Registry’ to evaluate the clinical utility of HeartCare testing services in monitoring heart transplant recipients. The study aims to enhance post-transplant care by utilizing HeartCare, which includes AlloMap® and AlloSure-Heart®, to detect allograft rejection through non-invasive methods. This registry is significant as it could improve patient outcomes and refine transplant monitoring protocols.
The intervention being tested is the HeartCare service, which combines AlloMap® and AlloSure-Heart® tests. AlloMap® assesses immune activity and rejection risk, while AlloSure-Heart® measures graft injury via donor-derived cell-free DNA. These tests aim to provide comprehensive surveillance for heart transplant recipients.
The study follows an observational cohort model with a prospective time perspective. It involves two groups: patients managed with HeartCare and a historical control group matched based on clinical factors. The primary purpose is to gather data on the effectiveness of HeartCare in real-world settings.
The study began on December 28, 2018, with its last update submitted on June 30, 2025. These dates are crucial for tracking the study’s progress and ensuring data relevance. The primary completion and estimated completion dates are yet to be disclosed.
For investors, this study update could positively impact CareDx’s stock performance by demonstrating the potential of HeartCare to become a standard in transplant monitoring. As the only non-invasive method recommended by ISHLT guidelines, HeartCare could position CareDx favorably against competitors in the transplant diagnostics market.
The study is ongoing, with further details available on the ClinicalTrials portal.