CareDx Validates Clinical Performance of AlloMap Kidney to Comprehensively Assess Transplant Rejection

Rhea-AI Summary

CareDx, Inc. (CDNA) announced new data from the multi-center OKRA study confirming that AlloMap Kidney can predict allograft rejection, specifically antibody-mediated rejection (ABMR) and T cell-mediated rejection (TCMR). With a negative predictive value of 95%, this gene expression profiling can effectively distinguish rejection from quiescence in kidney transplant patients. CEO Reg Seeto noted that these findings advance their KidneyCare solutions. This data aligns with previous studies indicating AlloSure's effectiveness in monitoring renal transplant rejection.

Positive

• AlloMap Kidney demonstrates a negative predictive value of 95% for allograft rejection.
• The study confirms AlloMap's ability to distinguish between rejection and quiescence.
• The data supports CareDx's efforts in developing comprehensive KidneyCare solutions.

Negative

• Potential risks associated with the accuracy of AlloMap Kidney performance.
• Uncertainty regarding the commercialization of KidneyCare solutions.

OKRA Multi-Center Prospective Study Confirms AlloMap Kidney Detects ABMR and TCMR Allograft Rejection

SOUTH SAN FRANCISCO, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients – today announced the publication¹ of new data demonstrating that AlloMap® Kidney gene-expression profiling predicts the probability of allograft rejection for both antibody-mediated rejection (ABMR) and T cell-mediated rejection (TCMR).

The new data, published in Biomarkers in Medicine, combining multiple data sets, including the multi-center, prospective OKRA (Outcomes of KidneyCare in Renal Allografts) study (NCT03326076), shows that AlloMap Kidney can reliably discriminate rejection from quiescence in kidney transplant patients with a negative predictive value of 95%. The results are consistent with previously published clinical validation study results.²

“This multi-center study delivers further evidence that AlloMap Kidney comprehensively assesses immunological risk of rejection,” said Reg Seeto, CEO and President of CareDx. “This moves us one step closer to being able to offer our multimodality KidneyCare solution to clinicians, an innovative new advancement for kidney transplant patients.”

“It’s exciting to see the data confirming the performance of AlloMap Kidney, on the heels of the landmark ADMIRAL study^3, which showed that AlloSure Kidney improves upon standard of care serum creatine for rejection surveillance and is an effective non-invasive service that can be used routinely to assess clinical and subclinical rejection,” said Dr. Yasir A. Qazi, Associate Professor of Clinical Medicine at Keck School of Medicine. “Together, these two biomarkers, gene-expression profiling and donor-derived cell-free DNA, will provide meaningful new insights to better personalize immunosuppression medication to prevent rejection and to safely reduce immunosuppression in patients with stable quiescent immune activity.”

CareDx is an innovator in multimodality transplant solutions. HeartCare, which includes AlloSure and AlloMap for heart transplant patients, is utilized by the majority of heart transplant centers in the United States.⁴ CareDx is bringing its deep expertise in multimodality care to the kidney transplant community with the eventual commercialization of KidneyCare.

About CareDx – The Transplant Company
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 potential benefits and results that may be achieved with AlloMap Kidney. 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 AlloMap Kidney; risks that the new data regarding AlloMap Kidney performance may not be accurate; risks that KidneyCare fails to eventually commercialize; 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, 2021 filed by CareDx with the SEC on February 24, 2022, 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

References:

1. Cheung R, Xu H, Jin X, et al. Validation of a gene expression signature to measure immune quiescence in kidney transplant recipients in the CLIA setting. Biomarkers in Medicine. Published Online: 29 Apr 2022. https://doi.org/10.2217/bmm-2022-0113
2. Akalin E, Weir MR, Bunnapradist S, et al. Clinical Validation of an Immune Quiescence Gene Expression Signature in Kidney Transplantation. Kidney360. December 2021, 2 (12) 1998-2009; DOI: https://doi.org/10.34067/KID.0005062021
3. Bu L, Gupta G, Pai A, et al, Clinical outcome from the Assessing Donor-derived cell-free DNA Monitoring Insights of kidney Allografts with Longitudinal surveillance (ADMIRAL) study. Kidney International. April 2022, 101(4) 793-803; doi: https://doi.org/10.1016/j.kint.2021.11.034.
4. CareDx data on file, May 4, 2022.

FAQ

What is the significance of the OKRA study results for CareDx (CDNA)?

The OKRA study confirmed that AlloMap Kidney can reliably predict allograft rejection with a 95% negative predictive value, enhancing CareDx's kidney transplant solutions.

When were the findings from the OKRA study published?

The findings from the OKRA study were published on May 5, 2022.

How does AlloMap Kidney help kidney transplant patients?

AlloMap Kidney helps by predicting the likelihood of allograft rejection, allowing for better management of immunosuppression.

What data supports the effectiveness of AlloMap Kidney?

The data includes results from the multi-center OKRA study and aligns with previous validation studies showing its predictive accuracy.

What are the risks associated with AlloMap Kidney according to CareDx's press release?

The press release indicates potential risks related to the accuracy of performance and uncertainty regarding the commercialization of KidneyCare.