Findings from ALAMO Study Show AlloSure Lung is Associated with Prognosis of Chronic Lung Allograft Dysfunction and Restrictive Allograft Syndrome

AlloSure Lung Surveillance Monitoring Identifies the Onset of Acute Cellular Rejection and Treatment Response

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – 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 that CareDx, together with study collaborators, presented new scientific evidence on the use of AlloSure® Lung in clinical practice at the International Society for Heart and Lung Transplantation (ISHLT) 45^th Annual Meeting & Scientific Sessions, held from April 27-30 in Boston, Massachusetts.

AlloSure Lung and AlloHome™ were featured in 8 abstracts including 2 oral presentations and key findings were:

• Surveillance monitoring using AlloSure Lung effectively identified rising dd-cfDNA levels signaling onset of acute cellular rejection and decline in levels after treatment for rejection (Abstract 1627).
• AlloSure Lung was used to monitor safety and graft function of Tacrolimus (TAC) inhalation powder as a replacement to oral TAC in lung transplant patients with renal insufficiency (Abstract 143, oral session).
• AlloSure Lung was used to investigate the impact of TAC drug levels on the outcomes of DSA-positive lung transplant recipients over a one-year follow-up (Abstract 403, mini oral).
• AlloHome remote patient monitoring system in lung transplant enables real-time treatment adjustments and improved triage, easing workload on transplant center staff (Abstract 1204).

“We are very pleased with the new data presented at ISHLT indicating that surveillance monitoring using AlloSure effectively detected rejection and could be used to monitor patient treatment responses,” said Robert Woodward, CareDx Chief Scientific Officer.

Additionally, during a CareDx sponsored symposium, an interim analysis of the ALAMO (AlloSure Lung Assessment and Metagenomics Outcomes) prospective, multi-center study showed that AlloSure Lung may be prognostic of Chronic Allograft Lung Dysfunction (CLAD), a leading cause of death after lung transplantation. Elevated levels of AlloSure dd-cfDNA in patients early post-transplant were associated with future occurrence of restrictive allograft syndrome (RAS), a severe form of CLAD.

"We have observed the advantages of using AlloSure Lung for monitoring patients for early signs of graft injury and rejection. The early findings from the ALAMO study are promising as it indicates that increased levels of AlloSure Lung dd-cfDNA may identify patients at higher risk of developing CLAD, which is a major cause of mortality among lung transplant patients," said Ciara Shaver, MD, PhD, Principal Investigator for ALAMO at Vanderbilt University Medical Center. "Furthermore, the ALAMO data show that AlloSure Lung may identify subclinical lung injury during CMV viremia. In these ways, AlloSure Lung may help clinicians to identify the patients with the greatest chance to respond to therapy to enhance long-term outcomes.”

For a complete listing of abstracts, oral presentations and posters featuring CareDx’s heart and lung transplant portfolio, please follow this link.

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 have been or may be achieved with AlloSure Lung, AlloHome, and other CareDx products, and statements regarding the interim study results of CareDx’s ALAMO registry at the 2025 International Society for Heart and Lung Transplantation Meeting (the “ISHLT Presentation”). 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 Lung, AlloHome, or other CareDx products or its ISHLT Presentation; risks that the ISHLT Presentation and the data to be presented may not follow the agenda as stated in this press release; risks that the findings in the studies 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250429933930/en/