CareDx Announces Presentation of Data at 2025 Tandem Meetings Demonstrating Strong Performance of AlloHeme in Early Relapse Detection for Hematologic Malignancies
13 2월 2025 - 9:05PM
Business Wire
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CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a
leading precision medicine company focused on the discovery,
development, and commercialization of clinically differentiated,
high-value healthcare solutions for transplant patients and
caregivers – today announced new AlloHeme data presented at the
2025 Tandem Meetings, Transplantation & Cellular Therapy
Meetings of ASTCT™ and CIBMTR®, held February 12-15, 2025 in
Honolulu, Hawaii.
In an oral presentation, a one-year interim analysis of the
ACROBAT prospective, multi-center study showed that AlloHeme™ is an
accurate and sensitive test for monitoring relapse after allogeneic
stem cell transplantation in Acute Myeloid Leukemia (AML) and
Myelodysplastic Syndromes (MDS). By measuring small changes in
mixed chimerism, AlloHeme demonstrated excellent performance
characteristics with a hazard ratio (HR) of 40.5 (p<0.001) for
relapse, and a clinically meaningful median lead time to relapse of
36 days. The analysis included one-year interim follow-up data from
a cohort of 229 patients with AML and MDS from 11 stem cell
transplant centers across the U.S.
“We are extremely pleased with the results of the ACROBAT study
which demonstrates that AlloHeme is highly accurate in predicting
risk of relapse in patients who have undergone a hematopoietic cell
transplant,” said Dr. Monzr M. Al Malki, Associate Professor, and
Director of Unrelated Donor Bone Marrow Transplant Program at City
of Hope National Medical Center. “This study gets us one step
closer to having a highly reliable molecular biomarker that enables
us to assess the status of the stem cell engraftment and predict
risk of relapse.”
CareDx's AlloHeme is an NGS-based test that has been shown to be
more sensitive than the current standard of care methods for
monitoring engraftment and relapse post-allogeneic hemopoietic stem
cell transplantation for hematologic malignancies.
“The interim results of the ACROBAT study build upon our growth
strategy to expand into hematology oncology. With AlloHeme, we can
detect relapse after allogeneic stem cell transplantation prior to
conventional methods, giving clinicians the significant lead time
they need to intervene sooner,” said Marica Grskovic, PhD, CareDx
Chief Strategy Officer. “We are very pleased with these results
demonstrating the high sensitivity of the AlloHeme assay and its
selection for an oral presentation at the Tandem Meetings given the
significant impact it may have on patient outcomes through earlier
detection of malignancy recurrence.”
About CareDx – The Transplant Company
CareDx, Inc., headquartered in Brisbane, 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 potential
benefits and results that may be achieved with AlloHeme. 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 numerous risks and
uncertainties, all of which are difficult to predict and many of
which are beyond CareDx’s control, that could cause actual results
to differ materially from those projected, including risks that
CareDx does not realize the expected benefits of AlloHeme. These
statements are also subject to general economic and market factors,
and other risks discussed in CareDx’s filings with the Securities
and Exchange Commission (the “SEC”), including, but not limited to,
the Annual Report on Form 10-K for the fiscal year ended December
31, 2023 filed by CareDx with the SEC on February 28, 2024, the
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024
filed by CareDx with the SEC on May 9, 2024, the Quarterly Report
on Form 10-Q for the fiscal quarter ended June 30, 2024 filed by
CareDx with the SEC on July 31, 2024, the Quarterly Report on Form
10-Q for the quarter ended September 30, 2024 filed by CareDx with
the SEC on November 4, 2024, 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. You are cautioned not to place undue reliance on these
forward-looking statements. CareDx expressly disclaims any
obligation, except as required by law, or undertaking to update or
revise any such forward-looking statements, whether as a result of
new information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20250213449450/en/
Media Contacts Anna Czene 818-731-2203 aczene@caredx.com
Investor Relations Caroline Corner investor@caredx.com
CareDx (NASDAQ:CDNA)
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