CareDx Launches ACROBAT Study to Potentially Change Care Paradigm for Stem Cell Transplant Patients

Rhea-AI Summary

CareDx, Inc. (NASDAQ: CDNA) has announced the enrollment of the first patient in the ACROBAT study, which investigates the potential of the AlloHeme testing tool in predicting relapse for patients undergoing allogeneic hematopoietic cell transplants. This multicenter study aims to evaluate the effectiveness of AlloHeme, which uses next-generation sequencing to monitor donor and recipient cell levels, enhancing patient surveillance post-transplant. With around 10,000 such transplants annually in the U.S., the outcome of this study could significantly impact patient care and surveillance in this area.

Positive

• First patient enrolled in ACROBAT study indicates progress in research.
• AlloHeme testing could redefine standards in monitoring post-transplant relapse.
• Potential for improved patient outcomes through earlier detection of relapse.

Negative

• None.

ACROBAT is the prospective multi-center study of AlloHeme, to study the potential of relapse surveillance for stem cell transplant patients

SOUTH SAN FRANCISCO, Calif., July 26, 2021 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients, today announced the enrollment of the first patient in the Assessing Chimerism and Relapse of Bone marrow/ HCT transplant using AlloHeme Testing (ACROBAT) study at the Cleveland Clinic in Ohio.

The ACROBAT study is a prospective, multicenter, observational cohort study to evaluate the use of AlloHeme, a microchimerism tool to predict post-transplant relapse in patients with allogeneic hematopoietic cell transplants (HCT), also known as bone marrow or stem cell transplants.

AlloHeme is an innovative testing solution that utilizes Next-Generation Sequencing technology to measure the relative amount of donor and recipient cells after a stem cell transplant. Monitoring for changes in chimerism over time using AlloHeme has the potential to significantly change patient surveillance and care in the underserved HCT patient population.

Approximately 10,000 allogeneic stem cell transplants occur in the US each year as a potential cure for patients with late-stage cancer, such as acute myelogenous leukemia, acute lymphoid leukemia, and myelodysplastic syndrome. Chimerism testing has played an important role in monitoring donor engraftment in HCT patients. Predicting relapse using microchimerism measurement may establish a new standard in HCT patient surveillance and could enable earlier intervention and better outcomes.

“We are excited to introduce AlloHeme as a new innovation in the field of stem cell transplantation. CareDx has led the way in improving the standards of care in solid organ transplant and cell therapy monitoring, and now we enter into the stem cell transplant field with this first patient enrolled in ACROBAT,” said Reg Seeto, CEO and President of CareDx.

“We are excited to work with CareDx on the ACROBAT study,” said Dr. Ronald Sobecks, Blood and Marrow Transplant Program, Taussig Cancer Institute and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. “Although chimerism monitoring after allogeneic HCT has been a standard practice for decades, disease relapse remains the leading cause of treatment failure post-transplant. Further refinements in chimerism monitoring using AlloHeme’s higher sensitivity testing with a standardized surveillance protocol may allow for earlier detection of disease relapse. Potential therapeutic interventions may be implemented more readily, which may improve outcomes.”

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 ACROBAT study, the sensitivity of AlloHeme and the potential for AlloHeme to significantly change patient surveillance and care in the underserved HCT patient population, and the potential to establish a new standard in HCT patient surveillance that may allow for earlier intervention, better outcomes or earlier detection of disease relapse. 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 enrollment; 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:
CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@caredx.com

Investor Relations
Greg Chodaczek
347-610-7010
investor@caredx.com 

FAQ

What is the ACROBAT study by CareDx?

The ACROBAT study is a multicenter, observational study evaluating the AlloHeme testing tool to predict relapse in patients undergoing allogeneic hematopoietic cell transplants.

What is AlloHeme and its significance in the ACROBAT study?

AlloHeme is a microchimerism testing tool that uses next-generation sequencing technology to monitor donor and recipient cells, potentially improving post-transplant relapse prediction.

How many allogeneic stem cell transplants occur annually in the U.S.?

Approximately 10,000 allogeneic stem cell transplants are conducted each year in the U.S.

What are the potential benefits of the ACROBAT study for HCT patients?

The study aims to establish a new standard in patient surveillance, allowing for earlier intervention and potentially better outcomes for patients post-transplant.

When was the first patient enrolled in the ACROBAT study?

The first patient was enrolled in the ACROBAT study on July 26, 2021.