CareDx Enrolls First Patients in the Largest Digital Study in Transplant Using AlloCare to Assess Patient Outcomes

Rhea-AI Summary

CareDx (Nasdaq: CDNA) has initiated the TEAMMATE study, the largest digital study to assess the AlloCare app's impact on organ transplant patients. Enrolling 4,000 participants from over 100 transplant centers, the study will analyze 90-day readmission rates and other health metrics across various organ transplants. The AlloCare app aids in medication management and tracking vital signs, aiming to improve patient adherence and outcomes. The study is crucial for evaluating whether technology can enhance transplant care.

Positive

• Enrollment of 4,000 patients signifies strong interest and potential for significant data.
• AlloCare app developed to enhance post-transplant patient care and medication adherence.
• Study aims to provide concrete data on improving health outcomes through digital tools.

Negative

• Risks of failing to enroll all patients or achieving expected study outcomes.
• Dependency on technology adoption by patients for success.

TEAMMATE Study to Assess Impact in 4,000 Patients Across 100 Transplant Centers

SOUTH SAN FRANCISCO, Calif., Nov. 18, 2021 (GLOBE NEWSWIRE) -- 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.”

About CareDx

CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.

Forward Looking Statements

This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the patient enrollment in TEAMMATE study (the “Study”), the Study’s measurement of the impact of using AlloCare, and the potential benefits and results that may be achieved through the Study and AlloCare. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that the CareDx does not realize the expected benefits of the Study or AlloCare; risks that CareDx fails to enroll 4,000 patients in the Study or conduct the Study as planned; risks that the Study fails to demonstrate that the use of AlloCare may achieve better outcomes; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed by CareDx with the SEC on February 24, 2021 and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Contacts
Sasha King
Chief Marketing Officer
(415) 287-2393
sking@CareDx.com

Investor Relations
Ian Cooney
(415) 722-4563
investor@CareDx.com

FAQ

What is the TEAMMATE study by CareDx?

The TEAMMATE study is a large-scale research initiative aimed at assessing the impact of the AlloCare mobile health app on organ transplant patient outcomes, enrolling 4,000 patients.

What outcomes will the TEAMMATE study measure?

The study will measure 90-day readmission rates, medication adherence, blood pressure management, organ rejection, and patient satisfaction levels.

How does AlloCare assist transplant patients?

AlloCare helps patients manage medications, schedule lab work, track vital metrics, and view test results, enhancing their overall post-transplant care.

What is the significance of enrolling 4,000 patients in the TEAMMATE study?

Enrolling 4,000 patients indicates strong engagement and is expected to yield valuable data on the effectiveness of digital health solutions in transplant care.

What are the risks associated with the TEAMMATE study?

Risks include potential enrollment failures and the possibility that the study may not demonstrate improved outcomes from using the AlloCare app.