CareDx Extends Leadership in Multimodality Transplant Care with KidneyCare Validation Publication

Rhea-AI Summary

CareDx, Inc. (CDNA) announced a multicenter study validating its solutions AlloMap and AlloSure for kidney transplantation, as published in Kidney360. This study, encompassing data from 14 top transplant centers, demonstrates that AlloMap can effectively differentiate between organ rejection and immune quiescence. The combination of AlloSure and AlloMap provides a comprehensive assessment, achieving a combined AUC of 0.894. CEO Reg Seeto emphasized the extended application of multimodality solutions in kidney care, reflecting CareDx's commitment to innovate in transplant medicine.

Positive

• AlloMap and AlloSure validated through data from 14 leading transplant centers.
• Combined AUC of 0.894 indicates strong performance in assessing kidney health.
• CEO emphasizes commitment to kidney transplantation innovations with KidneyCare.

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• None.

Multicenter Study Validates AlloMap and Demonstrates the Complementary Value with AlloSure for Detecting Rejection

SOUTH SAN FRANCISCO, Calif., Sept. 30, 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 announced a publication in Kidney360 of a multicenter study that demonstrates the clinical performance of AlloSure and AlloMap to inform biopsy and treatment decisions following kidney transplantation.

KidneyCare is CareDx’s multimodality solution that includes AlloSure and AlloMap, and is now clinically validated using data from fourteen leading kidney-transplant centers and hospitals across the United States. AlloSure is a measure of donor derived cfDNA, which identifies organ injury, and AlloMap is a measure of gene expression, which identifies immune quiescence. The Kidney360 publication demonstrates the ability of AlloMap to differentiate between rejection and immune quiescence using a range of scores, and shows that AlloMap is complementary to AlloSure, yielding a combined AUC of 0.894. Together, these biomarkers offer a comprehensive assessment of kidney health compared to the current standard of care.

“CareDx has been an innovator in multimodality solutions with the launch of HeartCare, which includes AlloSure and AlloMap for heart transplant patients and is now utilized by the majority of heart transplant centers. We are using this deep expertise to bring multimodality care to the kidney transplant community with KidneyCare,” said Reg Seeto, CEO at CareDx.

“Multi-modality solutions like KidneyCare offer real-time readouts of two different biomarkers, each with critical information about allograft risk and rejection,” said Enver Akalin, MD, Montefiore. “Complementary testing using next-generation genomic-expression testing represents a significant advance in post-surgical kidney care.”

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 Kidney360 publication of a multicenter study regarding the clinical performance of AlloSure and AlloMap (the “Kidney360 Publication”), and the potential benefits and results that may be achieved through KidneyCare, CareDx’s multimodality solution that includes AlloSure and AlloMap. 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 KidneyCare, AlloSure or AlloMap; risks that the results from the Kidney360 Publication may not be accurate; 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 does the recent study reveal about AlloMap and AlloSure?

The study demonstrates that AlloMap effectively distinguishes between kidney organ rejection and immune quiescence, validating its complementary use with AlloSure.

How many centers participated in the AlloMap and AlloSure study?

The study involved data from 14 leading kidney transplant centers across the United States.

What is the significance of the combined AUC of 0.894?

A combined AUC of 0.894 indicates strong clinical performance in assessing kidney health compared to current standards.

What is CareDx's focus in the healthcare market?

CareDx specializes in precision medicine solutions for transplant patients, offering testing services and healthcare solutions.

What does KidneyCare include?

KidneyCare is CareDx’s multimodality solution that comprises the biomarkers AlloSure and AlloMap.