Landmark Independent Publication in Nature Medicine Validates CareDx AlloView AI-Enabled Risk Prediction Model and Demonstrates AlloSure Kidney Detects Subclinical Rejection in Stable Patients
03 June 2024 - 9:05PM
Business Wire
Surveillance Monitoring with Both AlloSure
Kidney and the AlloView AI-Enabled Risk Prediction Model Improves
the Detection of All Types of Allograft Rejection
AlloSure Kidney Detected Subclinical Rejection
in Clinically Stable Patients and AlloSure Kidney dd-cfDNA Levels
were Elevated Prior to Biopsy Proven Rejection in an Analysis of
Patients Receiving Consecutive Biopsies
AlloSure dd-cfDNA Levels Declined in Response
to Immunosuppression Treatment Suggesting There May be Utility in
Therapy Monitoring for Recovery or Progression
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 in conjunction with the
2024 American Transplant Congress, the publication in Nature
Medicine1 of findings from the largest, real-world study of its
kind, assessing the role of AlloSure® donor-derived cell-free DNA
(dd-cfDNA) and of an AI-enabled rejection risk prediction model,
AlloView™ that incorporates AlloSure to improve detection,
characterization, and treatment of kidney allograft rejection.
“This landmark study in Nature Medicine further establishes the
clinical utility of AlloSure Kidney and the added value of
AlloView, our AI-enabled risk prediction model, in detecting the
presence, activity and severity of allograft rejection. These
findings contribute to a growing body of evidence establishing new
standards globally in the routine monitoring of rejection and
treatment response in kidney transplant patients," said John W.
Hanna, President & CEO of CareDx.
The international multicenter study of 2,882 patients with
AlloSure Kidney dd-cfDNA levels and matched biopsy results was
conducted by the Paris Institute for Transplantation and Organ
Regeneration along with researchers in the U.S. and Belgium. The
study evaluated AlloSure Kidney and used AlloView, an AI-enabled
risk prediction model, to predict rejection by combining AlloSure
with standard of care measures, including estimated glomerular
filtration rate (eGFR), proteinuria, change in serum creatinine,
donor-specific antibodies (DSA), and previous history of
rejection.
The study results published in Nature Medicine demonstrated the
following1:
- Surveillance monitoring with AlloSure Kidney and AlloView
improves the detection of antibody-mediated rejection (ABMR),
T-cell mediated rejection (TCMR), and subclinical rejection when
compared to standard of care measures.
- AlloSure Kidney detected subclinical rejection in clinically
stable patients.
- AlloSure Kidney dd-cfDNA levels were elevated prior to biopsy
proven rejection in an analysis of patients receiving consecutive
biopsies.
- AlloSure Kidney dd-cfDNA levels were associated with stability
in patients with immune quiescence, a significant increase for
patients with de novo allograft rejection, a significant decrease
for patients with successfully treated rejection, and remained at
elevated levels for patients with persistent allograft
rejection.
- In patients with acute rejection, AlloSure Kidney dd-cfDNA
levels were associated with the severity of acute rejection.
“This study underscores AlloSure dd-cfDNA’s role as a real-time
indicator of kidney transplant rejection, enabling clinicians to
intervene earlier before rejection occurs and to monitor
post-treatment progress without resorting to unnecessary biopsy
procedures,” said Alexandre Loupy, MD, PhD, Professor of Nephrology
and Statistics at Necker Hospital, and Director of the Paris
Institute of Transplantation and Organ Regeneration at the French
National Institute of Health (Inserm).
CareDx’s AlloSure dd-cfDNA was made commercially available in
2017, the industry’s first dd-cfDNA for use to non-invasively
identify the risk of allograft injury and rejection in kidney
transplantation. Since then, AlloSure has also become available for
clinical use in heart and lung transplant recipients. AlloView, an
AI-enabled risk prediction model is now commercially available.
AlloView optimizes patient risk prediction by integrating
artificial intelligence, AlloSure and standard of care
measures.2
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 AlloSure and
AlloView. 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 CareDx does
not realize the expected benefits of AlloSure and AlloView; risks
that the findings in the Nature Medicine study supporting the data
may be inaccurate; 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,
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, 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.
References
- Aubert, O., Ursule-Dufait, C., Brousse, R., et al. Cell-Free
DNA for the detection of kidney allograft rejection. Nat Med
(2024). https://doi.org/10.1038/s41591-024-03087-3
- AlloView is intended to support the healthcare provider’s
independent assessment of the patient’s post-transplant status.
AlloView is not intended to diagnose a condition or determine a
patient’s course of treatment. An AlloSure dd-cfDNA test result is
a required input of AlloView.
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version on businesswire.com: https://www.businesswire.com/news/home/20240603261518/en/
CareDx, Inc. Media Relations Anna Czene 818-731-2203
aczene@caredx.com
Investor Relations Greg Chodaczek investor@CareDx.com
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