AI Integration and Real-World Utility of CareDx Portfolio Highlighted in New Data at the 2024 American Transplant Congress

Rhea-AI Summary

CareDx has announced new data to be presented at the 2024 American Transplant Congress from June 1-5 in Philadelphia. The data will highlight the clinical utility of CareDx's products, including AI integration in kidney transplant monitoring.

AI-derived AlloView results correlate with biopsy-proven kidney rejection, enhancing early rejection risk prediction. AlloSure Kidney’s longitudinal monitoring helps identify graft injury earlier and assesses rejection treatments effectively.

KOAR data show AlloSure-informed biopsies detect more acute rejections compared to traditional methods. AlloSure can potentially reduce unnecessary biopsies in cases of delayed graft function, avoiding up to 36% of biopsies.

Additionally, AlloMap and AlloSure indicate lower cancer risk post-heart transplant. Experts will present these findings at a symposium moderated by Dr. Kiran Khush.

Positive

• AI-derived AlloView correlates with biopsy-proven kidney rejection, enhancing early risk prediction.
• AlloSure Kidney's longitudinal monitoring aids in early identification of graft injury and effective assessment of rejection treatments.
• KOAR data reveal AlloSure-guided biopsies detect more acute rejections than traditional indications (48% vs. 28%).
• AlloSure's use could reduce unnecessary biopsies by up to 36% in cases of delayed graft function.
• AlloMap and AlloSure show lower mean levels before cancer diagnosis in heart transplant patients.
• Significant presence at 2024 ATC with 36 oral presentations and posters, showcasing innovative approaches and AI integration.

Negative

• The PR does not provide specific financial data, leaving potential investors unclear about the company's financial performance.
• The effectiveness of AI-derived AlloView and AlloSure is based on correlation data, which may not guarantee consistent real-world performance.
• The presented studies are in scope and may not reflect broader clinical outcomes.
• Potential reduction in biopsy frequency might be offset by the need for sophisticated monitoring and AI tools, which could be costly.

Insights

Medical Research Analyst

The integration of artificial intelligence (AI) in CareDx’s solutions for transplant monitoring marks a significant leap forward in the field of precision medicine. AI-derived models like AlloView and AlloSure Kidney facilitate earlier and more accurate detection of graft injuries and rejection in kidney transplant patients. This makes it easier for clinicians to intervene promptly, potentially improving patient outcomes and extending the lifespan of transplanted organs. These advancements could result in a shift in standard clinical practices towards more AI-driven diagnostic tools, which might reduce reliance on invasive procedures like biopsies. For investors, this innovation could signify a stronger market positioning for CareDx in the transplant care industry, suggesting potential revenue growth and an increase in share value over the long term. The ability of AlloSure Kidney to detect acute and borderline T-cell mediated rejection more effectively than traditional methods enhances its clinical utility, which can drive adoption among healthcare providers. However, it's important to consider the regulatory landscape and potential competition. AI-based solutions in healthcare require rigorous validation and regulatory approval, which can be time-consuming and costly. Additionally, the market may see entries from other companies, which could dilute CareDx's competitive advantage. Nonetheless, the current data highlights a promising future for AI in transplant care, which is a positive indicator for stakeholders.

Oncology Doctor

The study examining the link between lower levels of AlloMap gene-expression profiling and AlloSure dd-cfDNA before the diagnosis of cancer in heart transplant patients is particularly interesting. It suggests that these biomarkers could potentially serve as early indicators for cancer risk post-transplantation. This could be groundbreaking, as early detection of malignancies in transplant patients can significantly impact treatment approaches and patient survival rates. For CareDx, this finding opens up new avenues for product development and could expand their market reach beyond transplant rejection monitoring to oncology-related applications. However, further research is needed to validate these findings across larger cohorts and different transplant types. This potential expansion into oncology monitoring could diversify CareDx's revenue streams, but it also comes with the challenge of navigating the oncology market, which is highly competitive and tightly regulated. Investors should watch for further studies and regulatory developments in this area, as these will be key factors in determining the real-world applicability and commercial success of these findings.

AI-Derived AlloView Results Correlate with Presence and Type of Biopsy Proven Kidney Rejection

Longitudinal Monitoring with AlloSure Kidney Enables Earlier Identification of Graft Injury and Assessment of Rejection Treatment

KOAR Data Show Kidney Biopsies Informed by AlloSure Detect More Acute Rejection than Biopsies Based on Traditional Indications

BRISBANE, Calif.--(BUSINESS WIRE)-- 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 data to be presented at the 2024 American Transplant Congress (ATC) being held June 1-5 in Philadelphia.

CareDx solutions are featured in 36 oral presentations and posters, and a symposium. The findings highlight innovative approaches, including AI integration, and the real-world clinical utility of CareDx’s solutions, emphasizing their significant impact on patient care and outcomes in kidney, heart, and lung transplantation.

“The additive value of artificial intelligence to our transplant solutions holds significant promise,” said John W. Hanna, CareDx President and CEO. “We are proud to have a leading presence at ATC and showcase new data on AI-enabled rejection monitoring, the clinical value of longitudinal monitoring with AlloSure Kidney, and the potential for biopsy reductions with AlloSure Kidney in real-world settings.”

Key data to be presented at 2024 ATC:

• Utilization of Artificial Intelligence (AI) in Predicting the Risk of Kidney Allograft Rejection, S. V. Shah, S. Voora, P. J. Hanson, et al. Poster Abstract Session D148. This independent study establishes reference values for AlloView™, correlating results with the presence and type of allograft rejection observed on kidney biopsies. AlloView is the first AI-derived model to predict rejection risk in kidney transplant patients by integrating AlloSure Kidney with other clinical and laboratory factors associated with rejection.
• Time-Varying Relative Changes in Donor-Derived Cell-Free DNA (dd-cfDNA) during Rejection and dnDSA Detection in Primary and Repeat Kidney Transplant Recipients (KTR), S. Parajuli, N. Garg, K. Pinney, et al. Poster Abstract Session A184. This study highlights the importance of AlloSure® Kidney for longitudinal monitoring of dd-cfDNA trends, enabling earlier identification of evolving graft injury and evaluating rejection treatment response.
• Donor-Derived Cell-Free DNA Increases the Yield of Acute Rejection and Borderline TCMR on Kidney Transplant Biopsies, J. Bromberg, D. Mandelbrot, M. Weir, et al. Poster Abstract Session A174. An analysis of KOAR (Kidney Outcomes with AlloSure Registry) data show that kidney biopsies based on AlloSure alone or AlloSure and traditional laboratory indications, significantly enhance detection of actionable findings, yielding acute rejection and borderline T-cell mediated rejection (TCMR) in 48% of cases compared to 28% with traditional for-cause biopsy indications alone.
• Clinical Utility of Donor-Derived Cell-Free DNA during the Period of Recovery of Renal Function after Kidney Transplantation, R. D. Foresto, Y. C. Dreige, I. Meira, et al, Rapid Fire Oral Abstract Session 363. Data show that using a threshold of AlloSure Kidney dd-cfDNA of >0.5% to guide surveillance biopsies during delayed graft function (DGF) or at 30 days post-transplant in the setting of incomplete recovery of kidney function would have avoided 23% and 36% of biopsies, respectively.
• Characterization of GEP and dd-cfDNA Profile with Long-Term Malignancy Risk Post-Cardiac Transplant, L. Chen, D. H. Lee, E. Czinn, et al. Poster Abstract Session C062. The study reveals that patients developing cancer after heart transplantation have lower mean levels of both AlloMap® gene-expression profiling and AlloSure dd-cfDNA before cancer diagnosis compared to propensity-matched patients.

A leading group of experts in the field will present findings from the recent SHORE (Surveillance HeartCare Outcomes Registry) publication and the latest data featuring AlloSure Kidney and AlloView, the first AI-derived model to predict rejection risk in kidney transplant patients. The sponsored symposium¹, “From Invasive to Intelligent: Utilizing Cutting-Edge Artificial Intelligence and Molecular Diagnostics in Real-World Clinical Practice,” will be moderated by Kiran Khush, MD, MAS, Stanford Medicine. Panelists include Alexandre Loupy, MD, PhD, Paris Transplant Group, Darshana Dadhania, MD, Weill-Cornell Medicine, Gaurav Gupta, MD, Virginia Commonwealth University, and Sean Pinney, MD, Mount Sinai Morningside.

"I am thrilled to moderate this exciting symposium sponsored by CareDx as it will explore the latest advancements in transplant monitoring and highlight the recent landmark SHORE publication along with new data on AlloSure Kidney and AlloView. The integration of AI in predicting rejection risk marks a significant leap forward in patient care," said Kiran Khush, MD, MAS, Cardiologist, Professor of Cardiovascular Medicine, Stanford Medicine.

For a complete listing of abstracts, oral presentations and posters go here.

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 AlloView, AlloSure, AlloMap, and other CareDx products (including with the use of artificial intelligence), and statements regarding the data to be presented at the 2024 American Transplant Congress (ATC). 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 AlloView, AlloSure, AlloMap, and other CareDx products (including with the use of artificial intelligence); risks that the data to be presented at the ATC may not follow the agenda as stated in this press release; risks that the findings in the studies 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:

1. The symposium is an independent, non-CME event.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240530179664/en/

CareDx, Inc.

Media Relations

Anna Czene

818-731-2203

aczene@caredx.com

Investor Relations

Greg Chodaczek

investor@caredx.com

Source: CareDx, Inc.

FAQ

What is the significance of the AI-derived AlloView in CareDx's new data?

AI-derived AlloView correlates with biopsy-proven kidney rejection, enhancing early prediction of rejection risk in kidney transplant patients.

How does AlloSure Kidney help in transplant care according to CareDx's latest data?

AlloSure Kidney aids in early identification of graft injury and effective assessment of rejection treatments through longitudinal monitoring.

What do the KOAR data reveal about AlloSure-informed kidney biopsies?

KOAR data show that AlloSure-informed biopsies detect more acute rejections (48%) compared to traditional indications (28%).

Can AlloSure reduce the frequency of unnecessary biopsies?

Yes, AlloSure could reduce unnecessary biopsies by up to 36% in cases of delayed graft function or incomplete recovery post-transplant.

What does the data say about cancer risk in heart transplant patients using AlloMap and AlloSure?

The data indicate that heart transplant patients who develop cancer have lower mean levels of AlloMap and AlloSure before diagnosis compared to propensity-matched patients.

When and where will CareDx present its new data?

CareDx will present its new data at the 2024 American Transplant Congress in Philadelphia from June 1-5.