Third SHORE Publication Highlights HeartCare’s Role in Risk Stratification and Personalized Post-Transplant Care

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 the publication of the third manuscript from Surveillance HeartCare Outcomes Registry (SHORE) in the Journal of Heart and Lung Transplantation (JHLT). The analysis, titled “Multimodal Molecular Testing Provides Prognostic Value for Heart Transplant Recipients”, underscores the critical role of HeartCare^® in guiding clinical decisions for heart transplant patients.

The third SHORE manuscript included 1,934 heart transplant recipients from 59 centers and demonstrated that HeartCare’s molecular signals can reveal risk for adverse outcomes even when biopsy results appear normal. Patients with positive HeartCare results, including both AlloMap^® and AlloSure^® Heart, were found to be at a significantly higher risk for rejection-related complications.

“This analysis from SHORE demonstrated that positive HeartCare results—when both AlloMap and AlloSure are elevated—pinpoint the heart transplant recipients at highest risk for graft dysfunction and cardiovascular death,” said Dr. Kiran Khush, Professor of Medicine at Stanford University and corresponding author of the study. “With this prognostic information, clinicians can closely monitor patients who most need it, potentially improving their outcomes.”

Key Findings

• Positive HeartCare results (AlloMap and AlloSure Heart) between 2–6 months post-transplant were associated with a nearly twofold increase in the cumulative incidence of graft dysfunction and cardiovascular death in the following year in the positive HeartCare group (15.5% vs. 8.5% or lower for other groups, p=0.009).
• This elevated risk persisted even among patients without histological evidence of rejection, indicating that molecular testing provided independent prognostic information not detected by biopsy.
• A positive HeartCare result at any time (2 months to 5 years post-transplant) was associated with a threefold increase in the 30-day risk of graft dysfunction or cardiovascular death.
• Even in the setting of acute cellular rejection (ACR), positive HeartCare results conferred a significantly higher risk for subsequent graft dysfunction or cardiovascular death compared to other molecular result combinations.

“These SHORE analyses challenge the paradigm of the biopsy as the gold standard for assessing graft injury, showing that HeartCare’s molecular insights can identify risk that histology alone may miss,” said Dr. Jeff Teuteberg, Chief Medical Officer of CareDx. “This study empowers clinicians to deliver more personalized care and establishes the scientific rationale for an interventional study to test the impact of treating patients with abnormal HeartCare results despite having a normal biopsy.”

The full publication is available online at: https://www.jhltonline.org/article/S1053-2498(25)02400-3/fulltext

About CareDx

CareDx, Inc., headquartered in South San Francisco, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. For more information, 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 Heart, AlloMap, and HeartCare. 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 Heart, AlloMap, and HeartCare, risks that the findings in the SHORE study supporting the data may be inaccurate, general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by CareDx with the SEC on February 28, 2025, 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. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

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