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Thu. 18 Nov 2021, 7:02am ETBenzinga
In: Biotech, News, FDA, General

CareDx, Inc. (NASDAQ:CDNA) – The Transplant Company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced the enrollment of the first patients in what will be the largest ever digital study measuring the impact of AlloCare™, a tech-enabled mobile health app, on organ transplant patient outcomes.

The TEAMMATE (Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient) study will enroll 4,000 patients from more than 100 transplant centers nationwide as part of a prospective, randomized, controlled, multicenter study spanning kidney, heart, lung, and liver transplantation. Half of the participants will be enrolled in the study arm and half in the control arm. The study arm will have patients trained for regular use of the AlloCare mobile health app. The control arm will maintain the center's standard of care. The primary endpoint will be 90-day readmission rates. The secondary endpoints will include medication adherence, blood pressure management, organ rejection at 3, 6, and 12 months, and patient satisfaction levels.

AlloCare is a patient management app that helps transplant recipients precisely manage their medications, schedule their lab work, track their blood pressure and other vital metrics, view their AlloSure® and other test results, and connect with other transplant recipients. AlloSure is a non-invasive transplant diagnostic tool that measures donor-derived cell-free DNA (dd-cfDNA) levels released into the blood stream to indicate potential, post-transplant allograft injury.

"AlloCare is a comprehensive, tech-enabled mobile health app created specifically for transplant patients, and that's critically important because precise management of immunosuppressive medications is the most important factor in lowering the risk of organ rejection," said Dr. Sham Dholakia, Chief Medical Officer at CareDx. "This study will test the hypothesis that using AlloCare will empower solid organ transplant patients and their caregivers to achieve better adherence and, ultimately, better outcomes."

"Effective post-transplant care requires that recipients adhere precisely to their medication schedule, and this large-scale study will determine whether we can drive improvements in clinical outcomes by deploying a comprehensive mobile health app created specifically for transplantation," said Dr. Malay Shah, Associate Professor of Surgery at the University of Kentucky. "Unfortunately, medication non-adherence is far too common, and I look forward to seeing how AlloCare can not only help improve patient adherence but health outcomes as well."