CareDx’s AlloSure Demonstrates Better Accuracy Than Current Standards of Care in Independent Kidney Transplant Study

Rhea-AI Summary

CareDx announced the successful completion of a longitudinal study by OrganX involving over 1,000 kidney transplant patients. This study demonstrated that AlloSure Kidney can more accurately detect allograft rejection compared to traditional methods like eGFR and DSA testing. Key findings indicate that increased dd-cfDNA levels correlate with rejection activity. CEO Reg Seeto highlighted that this is the largest cohort of paired-biopsy results comparing AlloSure to standard care. The study solidifies AlloSure's position in the transplant monitoring market.

Positive

• AlloSure Kidney demonstrated higher accuracy in detecting allograft rejection compared to traditional methods.
• The study involved a large cohort of 1,196 kidney transplant patients, enhancing data reliability.
• Incremental rise in dd-cfDNA levels correlates with increasing Banff lesion scores, indicating strong predictive capability.

Negative

• None.

Landmark Longitudinal Study in Over 1,000 Transplant Patients Confirms AlloSure More Accurately Measures Organ Health

SOUTH SAN FRANCISCO, Calif., Oct. 21, 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 and caregivers – today congratulated OrganX on the completion of a landmark longitudinal study that shows AlloSure is more accurate than current standards of care, including estimated glomerular filtration rate (eGFR) or donor specific antibody (DSA) testing, in detecting allograft rejection.

New data on AlloSure Kidney was presented at the European Society of Transplant Congress held in Milan in September 2021 and the abstract published in Transplant International. In an analysis of paired-biopsy results of 1,196 kidney patients taken from 2013 to 2018, the study conclusively demonstrated that AlloSure® Kidney showed independent and incremental predictive capability when compared to standard of care patient monitoring, including circulating anti-HLA DSA, eGFR, proteinuria, and occurrence of a recent clinical or immunologic event. The study shows AlloSure Kidney detects both antibody mediated rejection (ABMR) and T-cell mediated rejection (TCMR) with great accuracy and reproducibility.

OrganX was founded by Alexandre Loupy, who also runs the Paris Transplant Group, a leading expert in machine learning and artificial intelligence to personalize transplant medicine. While AlloSure Kidney has only been on the market for three years, OrganX’s longitudinal study was made possible by measuring dd-cfDNA levels in kidney transplant patients from 2013 to 2018 using stored blood samples.

“Better, earlier data gives transplant physicians opportunities to make more informed decisions sooner as they attempt to save organs and lives throughout the transplant journey,” said Alexandre Loupy, MD PhD, OrganX founder and the principal study investigator. “Our data confirms that AlloSure Kidney can more accurately gauge the risk of immunologic events, giving more accurate information earlier than the standard of care.”

Confirmatory findings include:

• Higher AlloSure-measured dd-cfDNA levels were observed for T-cell mediated rejection (TCMR) and antibody mediated rejection (AMR)
• Incremental rise in AlloSure-measured dd-cfDNA levels correlated with increasing Banff lesion scores for rejection activity
• No association of AlloSure-measured dd-cfDNA levels with allograft-inactive lesions
  

“This is the largest cohort of longitudinal, paired-biopsy results ever collected comparing AlloSure to the standard of care,” said CareDx CEO Reg Seeto. “OrganX further validates that AlloSure performance is very strong, and we look forward to the full publication next year.”

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 results of the OrganX longitudinal study of AlloSure® Kidney (the “Study”), the prospects of AlloSure® Kidney and the ability of AlloSure® Kidney to more accurately gauge the risk of immunologic events, giving more accurate information earlier than the current standards of care. 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 AlloSure® Kidney; the risks that the results of the Study are not replicated in future studies; 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
Ian Cooney
(415) 722-4563
investor@CareDx.com

FAQ

What were the key findings of the OrganX study regarding CDNA?

The OrganX study found that AlloSure Kidney is more effective than traditional monitoring methods in detecting allograft rejection.

How many patients were involved in the OrganX study related to CDNA?

The study involved 1,196 kidney transplant patients.

What does the AlloSure Kidney test measure?

AlloSure Kidney measures donor-derived cell-free DNA (dd-cfDNA) levels to assess organ health post-transplant.

When were the study results presented for CDNA?

The study results were presented at the European Society of Transplant Congress in September 2021.

Who is the founder of OrganX involved in the study related to CDNA?

Alexandre Loupy, who is a leading expert in transplant medicine, is the founder of OrganX.