CareDx Sponsored ISHLT Innovation Challenge Award Tackles Chronic Lung Allograft Dysfunction

Donor-Derived Cell-Free DNA will be Used to Evaluate Treatment to Improve Lung Transplant Outcomes

SOUTH SAN FRANCISCO, Calif., May 18, 2022 (GLOBE NEWSWIRE) -- 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 that the International Society for Heart and Lung Transplantation (ISHLT) has selected Dr. Berta Sáez-Giménez as the winner of the CareDx sponsored ISHLT Innovation Challenge Award.

Along with her collaborators at the Hospital Vall Hebrón in Barcelona, Spain, Dr. Sáez-Giménez will use AlloSeq™ cfDNA (cell-free DNA) to monitor the treatment of chronic lung allograft dysfunction, a condition associated with high mortality and morbidity in lung transplantation.^1,2

Lung transplant patients have one of the lowest median survivals of any solid organ transplant recipient, with a five-year survival rate of approximately 53%³, and chronic lung allograft dysfunction is one of the leading causes of mortality.^1,2 CareDx has made AlloSeq cfDNA available to laboratories outside the U.S. to enable testing analogous to AlloSure^® Lung, which can offer early warnings to physicians of organ injuries, including rejection which can help inform timely interventions.²  AlloSeq cfDNA is CE marked in Europe for surveillance of dd-cfDNA in solid organ transplantation.

"As a leader committed to advancing the field of transplantation, CareDx is proud to sponsor the ISHLT Innovation Challenge Award. This award will help advance the important research that Dr. Sáez-Giménez is undertaking to address one of the most pressing issues facing lung transplant patients, the development of irreversible chronic lung allograft dysfunction and one of the leading causes of mortality," said Reg Seeto, CEO and President of CareDx.

The ISHLT Innovation Challenge Award recognized research proposals that evaluated the clinical utility of using non-invasive solutions to improve outcomes in heart and lung transplant patients - specifically, research evaluating the clinical utility of combining donor-derived cell-free DNA (dd-cfDNA) and gene-expression profiling (GEP) in heart transplantation, or dd-cfDNA in lung transplantation.

"When the ISHLT panel of judges (comprised of ISHLT Grants and Awards Committee members, including researchers and clinicians) selected the winner for this award, we prioritized projects that can improve allograft survival in heart and lung transplant patients and were excited for investigators to explore important areas wherein non-invasive biomarkers such as donor-derived cell-free DNA or gene-expression profiling, could address a critical medical need," said Kathleen L. Grady, PhD, chair of the ISHLT Grants and Awards Committee and Administrative Director, Center for Heart Failure of the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital and Professor of Surgery and Medicine, Northwestern University, Chicago, IL.

Robert Woodward, PhD, Sr. Vice-President of Research and Development at CareDx adds, "ISHLT's selection of Dr. Sáez-Giménez's project aligns with the objective of defining the utility of dd-cfDNA to tackle an important medical need by addressing chronic lung allograft dysfunction, a condition with poor outcomes, with a well-designed study to answer critical question of monitoring treatment."

The selected project aims to focus on the correlation of dd-cfDNA and chronic lung allograft dysfunction (CLAD), which is the main complication hampering survival in patients at Dr. Sáez-Giménez's clinic. In particular, the team will evaluate the utility of dd-cfDNA to assess response to CLAD treatment. It is the hope of Dr. Sáez-Giménez's research team that early detection of immunologic complications might help to understand the underlying pathophysiological mechanisms that lead to CLAD.

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 Dr. Sáez-Giménez's winning of CareDx's sponsored ISHLT Innovation Challenge Award (the "Award") and her research to use AlloSeq™ cfDNA to monitor the treatment of chronic lung allograft dysfunction (the "Research"). 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 and Dr. Sáez-Giménez do not realize the expected benefits of the Research; risks that Dr. Sáez-Giménez fails to conduct the Research; 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 first quarter of 2022 ended on March 31, 2022 filed by CareDx with the SEC on May 5, 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. Chambers DC, Yusen RD, Cherikh WS, Goldfarb SB, Kucheryavaya AY, Khusch K, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirty-Fourth Adult Lung And Heart-Lung Transplantation Report-2017; Focus Theme: Allograft Ischemic Time. J Hear Lung Transpl (2017) 36:1047–59. doi: 10.1016/j.healun.2017.07.016
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. The Journal of Heart and Lung Transplantation. December 26, 2021. DOI: https://www.jhltonline.org/article/S1053-2498(21)02630-9/fulltext
3. Organ Procurement and Transplantation Network National Data. https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/ Accessed online December 31, 2021.