Landmark Independent Publication in Nature Medicine Validates CareDx AlloView AI-Enabled Risk Prediction Model and Demonstrates AlloSure Kidney Detects Subclinical Rejection in Stable Patients

Rhea-AI Summary

CareDx announced a landmark publication in Nature Medicine validating their AI-enabled risk prediction model, AlloView, and AlloSure Kidney, a donor-derived cell-free DNA (dd-cfDNA) test. The study, conducted by the Paris Institute for Transplantation and Organ Regeneration with U.S. and Belgian researchers, involved 2,882 patients and showed that combining AlloView with AlloSure and standard care measures enhances detection and characterization of kidney allograft rejection. Key findings include AlloSure's ability to detect subclinical rejection and predict biopsy-proven rejection, and AlloView's utility in therapy monitoring. This validation supports the clinical utility of these tools in routine kidney transplant patient monitoring, potentially setting new global standards.

Positive

• Validation in Nature Medicine enhances credibility.
• AlloView optimizes rejection risk prediction using AI.
• AlloSure detects subclinical rejection in stable patients.
• Study confirms AlloSure's predictive value before biopsy.
• Findings may set new global standards in transplant monitoring.
• Large-scale study with 2,882 patients enhances reliability.
• AlloSure useful in monitoring therapy effectiveness.
• AlloView available for commercial use, integrating AI and standard care measures.

Negative

• Study's scope to kidney transplants; other organs not extensively covered.
• Long-term efficacy and cost-effectiveness of AlloSure and AlloView not fully addressed.
• Reliance on AI models poses risks if data accuracy is compromised.

Insights

Medical Research Analyst

The inclusion of Nature Medicine as the publication venue for this study is a strong endorsement of the research's quality and importance. This journal is highly respected in the medical community and publication there signifies that the study has undergone rigorous peer review.

The findings on AlloSure Kidney and the AlloView AI-enabled risk prediction model present multiple implications. The ability of AlloSure to detect subclinical rejection in stable patients is particularly critical. Traditionally, kidney transplant rejection is diagnosed through invasive biopsy, which carries risks and discomfort. The demonstration that AlloSure can detect rejection through a non-invasive blood test prior to clinical symptoms or biopsy-proven rejection is a major advancement. This could lead to earlier intervention, potentially improving patient outcomes and extending the life of the transplanted kidney.

Furthermore, the ability of AlloSure to monitor therapy response adds another layer of utility. By tracking levels of donor-derived cell-free DNA (dd-cfDNA), clinicians can assess the effectiveness of immunosuppressive treatments in real-time and adjust therapies accordingly. This is particularly important given the delicate balance required in immunosuppressive therapy to prevent rejection while minimizing adverse effects.

Financial Analyst

From a financial perspective, the publication of these findings in such a prestigious journal can be expected to positively impact CareDx's stock. The validation of AlloSure and AlloView through peer-reviewed research provides a strong foundation for increased adoption by the medical community. This could translate into higher sales and revenue growth for CareDx.

Additionally, the study's international scope, involving multiple centers and a large patient cohort, strengthens the generalizability of the findings. This broad applicability across different healthcare settings can enhance market penetration and customer confidence globally.

Investors should also note the potential for this technology to reduce healthcare costs. By potentially decreasing the need for invasive biopsies and enabling more precise immunosuppressive therapy management, AlloSure and AlloView could save costs for healthcare systems. This cost-saving potential adds another attractive dimension to the product's value proposition.

Oncology Doctor

The implications of the study for clinical practice are significant. The ability to monitor dd-cfDNA levels in real-time provides a valuable tool for transplant physicians. This could lead to more personalized and precise care for transplant patients. The non-invasive nature of the test is particularly beneficial, as it reduces the need for biopsies, which can be uncomfortable and carry risks for patients.

The findings also confirm the role of AlloSure in detecting various types of rejection, including antibody-mediated rejection (ABMR) and T-cell mediated rejection (TCMR). Having a reliable, non-invasive method to detect rejection early can significantly impact patient management and outcomes. The association of dd-cfDNA levels with the severity of acute rejection further underscores its clinical utility.

This study also suggests potential utility in therapy monitoring, as dd-cfDNA levels declined in response to effective treatment. This can help in assessing and adjusting treatment plans more effectively, potentially improving recovery and long-term outcomes for patients.

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

BRISBANE, Calif.--(BUSINESS WIRE)-- 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

1. 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
2. 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.

View source 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

Source: CareDx, Inc.

FAQ

What is AlloView and how does it help kidney transplant patients?

AlloView is an AI-enabled risk prediction model that integrates AlloSure and standard care measures to enhance detection and treatment of kidney allograft rejection.

How does AlloSure Kidney detect subclinical rejection in stable patients?

AlloSure Kidney measures donor-derived cell-free DNA (dd-cfDNA) levels, which are elevated prior to biopsy-proven rejection, allowing early detection of subclinical rejection.

What were the key findings of the Nature Medicine study on AlloSure and AlloView?

The study confirmed that AlloSure detects subclinical rejection and AlloView improves risk prediction, aiding in earlier intervention and monitoring therapy effectiveness.

How many patients were involved in the AlloSure and AlloView study?

The study involved 2,882 patients and was conducted by international researchers.

What is the significance of AlloSure dd-cfDNA in kidney transplantation?

AlloSure dd-cfDNA serves as a real-time indicator of kidney transplant rejection, enabling earlier interventions and reducing the need for unnecessary biopsies.

When was AlloSure first made commercially available?

AlloSure was first made commercially available in 2017 for non-invasive identification of allograft injury and rejection in kidney transplants.

Is AlloView available for other types of organ transplants?

AlloSure is available for kidney, heart, and lung transplants, and AlloView, which integrates AI, is now commercially available for optimizing patient risk prediction.