Independent Prospective Study Defines Reference Range for CareDx’s AlloSure for Long-Term Lung Transplant Surveillance

First Study to Establish AlloSure Lung dd-cfDNA Baseline Beyond Two Years Post-Transplant by Evaluating Clinically Stable Patients

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced the results of a new study published in Transplantation Direct¹ which establishes a reference baseline when using AlloSure® Lung in the long-term surveillance of lung transplant patients.

“CareDx’s focus is to deliver innovation for transplant patients, and this is especially critical in lung where one in two grafts fail five years post-transplant. We are pleased to see the results of this new study which adds to the growing body of clinical evidence for AlloSure lung^2-5 and establishes a reference for use in the long-term surveillance of lung transplant recipients,” said Reg Seeto, CEO and President of CareDx. “Today, sixty percent of lung centers are already using our services, evidence that the clinical utility of AlloSure Lung is being borne out, consistent with the widespread adoption of AlloSure in kidney and heart transplantation.”

The independent observational study performed at Vanderbilt University Medical Center measured AlloSure dd-cfDNA levels in clinically stable lung transplant patients two years post-transplant during routine clinic appointments, every three months. In an analysis of fifty-one patients with at least three AlloSure dd-cfDNA measurements, the reference baseline was defined for using AlloSure in the long-term surveillance of lung transplant patients. Additionally, the study defined the reference change value of 73 percent for patients greater than two years post-transplant, consistent with the 70 percent reference change value published for earlier post-transplant timeframes.³

“We are pleased with the results of this study as we now have longitudinal data in patients two years post-transplant that helps to establish the reference baseline when using AlloSure dd-cfDNA as a molecular biomarker in the long-term surveillance of lung transplant patients,” said Anil J. Trindade, MD, Assistant Professor in the Department of Medicine and Associate Medical Director for Lung Transplant at Vanderbilt University Medical Center. “This study adds to the body of evidence supporting the use of AlloSure Lung. There is a significant unmet need to monitor these high-risk patients where the rates of lung transplant failure are very high, and it is estimated that one out of two lung transplants are likely to fail in the first five years post-transplant.”

For more details, read the publication here.

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 may be achieved with AlloSure Lung on transplant patients and the value of the independent study on AlloSure Lung conducted by Vanderbilt University Medical Center (the “Study”). 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 the AlloSure Lung or the Study; risks that the results of the Study 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, 2021 filed by CareDx with the SEC on February 24, 2022, the quarterly report on Form 10-Q for the quarter ended March 31, 2022 filed by CareDx with the SEC on May 5, 2022, the quarterly report on Form 10-Q for the quarter ended June 30, 2022 filed by CareDx with the SEC on August 4, 2022, the quarterly report on Form 10-Q for the quarter ended September 30, 2022 filed by CareDx with the SEC on November 3, 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.

CareDx, Inc.

References:

1. Trindade AJ, Chapin KC, Mullican A, et al. Assessment of dd-cfDNA Levels in Clinically Stable Lung Allograft Recipients Beyond the Initial 2 y Posttransplant. Transplant Direct. 2022 Nov 17;8(12): e1411. doi:10.1097/TXD.0000000000001411. PMID: 36406896; PMCID: PMC9671749.
2. Keller M, Sun J, Mutebi C, et al. Donor-derived cell-free DNA as a composite marker of acute lung allograft dysfunction in clinical care. J Heart Lung Transplant. 2022 Apr;41(4):458-466. doi: 10.1016/j.healun.2021.12.009. Epub 2021 Dec 26. PMID: 35063338.
3. Keller M, Mutebi C, Shah P, et al. Biological Variation of Donor-Derived Cell-Free DNA in Stable Lung Transplant Recipients. J Appl Lab Med. 2022 Jun 30;7(4):901-909. doi: 10.1093/jalm/jfab171. Erratum in: J Appl Lab Med. 2022 Nov 12; PMID: 35024828.
4. Khush KK, De Vlaminck I, Luikart H, et al. Donor-derived, cell-free DNA levels by next-generation targeted sequencing are elevated in allograft rejection after lung transplantation. ERJ Open Res. 2021 Jan 25;7(1):00462-2020. doi: 10.1183/23120541.00462-2020. PMID: 33532456; PMCID: PMC7836440.
5. Sayah D, Weigt SS, Ramsey A, et al. Plasma Donor-derived Cell-free DNA Levels Are Increased During Acute Cellular Rejection After Lung Transplant: Pilot Data. Transplant Direct. 2020 Sep 24;6(10): e608. doi: 10.1097/TXD.0000000000001063. PMID: 33062841; PMCID: PMC7515612. 

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