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 assess the effectiveness of HeartCare, which includes AlloMap® and AlloSure-Heart®, in providing comprehensive surveillance for allograft rejection. This registry is significant as it utilizes non-invasive methods to enhance post-transplant care, aligning with international guidelines.
The intervention being tested is the HeartCare service, which combines AlloMap® and AlloSure-Heart® diagnostics. AlloMap® evaluates immune activity and rejection risk through gene-expression profiling, while AlloSure-Heart® measures donor-derived cell-free DNA to detect graft injury.
The study follows a prospective cohort observational model, focusing on heart transplant recipients. Participants are not randomly allocated, and the primary purpose is to gather data on the utility of HeartCare in clinical settings. There is no masking involved in the study.
The study commenced on December 28, 2018, with an estimated completion date in 2025. The most recent update was submitted on June 30, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
This update could positively influence CareDx’s stock performance by reinforcing investor confidence in its innovative diagnostic solutions. As the company continues to advance its offerings in the transplant care market, it may also impact competitors focusing on similar technologies.
The study is ongoing, with further details available on the ClinicalTrials portal.