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CareDx Announces XenoSure and XenoMap

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CareDx, Inc. (Nasdaq: CDNA) has launched XenoSure™ and XenoMap™, the world’s first surveillance solutions for investigational use in xenotransplantation research and post-transplant clinical monitoring. These non-invasive tests assess organ graft health, with XenoSure detecting graft injury and XenoMap evaluating immune status. Used during a historic pig-to-human heart transplant at the University of Maryland, these innovations mark a significant advancement in transplant diagnostics. CareDx aims to enhance long-term outcomes for transplant patients through continuous innovation.

Positive
  • Launch of XenoSure and XenoMap as the first non-invasive surveillance tools for xenotransplantation.
  • Used in the world's first pig-to-human heart transplant, showcasing practical application.
  • Significant market acceptance with over 90% of heart, 70% of kidney, and 40% of lung transplant centers utilizing CareDx products.
Negative
  • Forward-looking statements include risks that anticipated benefits from XenoSure and XenoMap may not be realized.

Represents World’s First Surveillance Solutions for Investigational Use in Xenotransplantation Research and Post-Xenotransplant Clinical Monitoring

SOUTH SAN FRANCISCO, Calif., March 23, 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 the availability of XenoSure™ donor-derived cell-free DNA (dd-cfDNA) and XenoMap™ gene-expression profiling for investigational use in xenotransplantation research and post-xenotransplant clinical monitoring.

Surgeons from the University of Maryland School of Medicine (UMSOM) recently used XenoSure and XenoMap, two complementary, non-invasive CareDx surveillance solutions, experimentally, for multimodal assessment of organ graft health in the world’s first pig-to-human heart xenotransplant. XenoSure is used to detect graft injury and XenoMap to assess immune quiescence.

“The rate of innovation in xenotransplantation is accelerating, and CareDx is proud to be the diagnostic leader by introducing XenoSure and XenoMap as the first molecular surveillance testing services for research use in these medical breakthroughs,” said Reg Seeto, CEO and President of CareDx. “XenoSure and XenoMap are now available for use in the clinical research setting to help monitor post-transplant organ health and generate insights to better understand how we can improve long-term outcomes.”

“I look forward to continuing our important work using innovative non-invasive xenotransplantation surveillance solutions to gain meaningful insights that help us make further scientific advancements that may one day make xenotransplants a lifesaving option for patients,” said Dr. Muhammad Mohiuddin, Professor of Surgery, Director, Program in Cardiac Xenotransplantation at the University of Maryland School of Medicine.

CareDx is dedicated to driving innovation in the transplant field. In May 2021 CareDx announced a minority investment in Miromatrix, a biotechnology company working to eliminate the need for an organ transplant waiting list through the development of implantable engineered biological organs, to help advance their important work. CareDx and Miromatrix are also collaborating on certain research and development activities using CareDx technology. AlloMap® Heart was the first non-invasive blood test to monitor immune quiescence in heart transplant patients and AlloSure® was the first dd-cfDNA to monitor organ rejection in heart, kidney, and lung transplant patients. CareDx has served over 80,000 organ transplant patients with its AlloSure or AlloMap assays for their post-transplant care.1 More than 90 percent of the nation’s heart transplant centers, 70 percent of kidney transplant centers, and 40 percent of lung transplant centers use CareDx products to monitor their patients’ transplanted organ health.1

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 XenoSure, XenoMap, and their use in xenotransplantation research and post-xenotransplant clinical monitoring. 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 XenoSure, XenoMap, or their use in xenotransplantation research and post-xenotransplant clinical monitoring; 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

___________________________________

  1. CareDx data on file. March 15, 2022.

 


FAQ

What are XenoSure and XenoMap by CareDx?

XenoSure and XenoMap are non-invasive surveillance solutions for monitoring organ health in xenotransplantation research and post-transplant clinical settings.

When were XenoSure and XenoMap launched by CareDx?

CareDx announced the launch of XenoSure and XenoMap on March 23, 2022.

How do XenoSure and XenoMap contribute to xenotransplantation?

They help assess graft injury and immune status, aiding in the monitoring of organ health post-transplant.

Which medical institution first used XenoSure and XenoMap?

Surgeons from the University of Maryland School of Medicine were the first to use XenoSure and XenoMap.

What is CareDx's mission?

CareDx focuses on delivering high-value healthcare solutions for transplant patients and advancing innovation in the transplant field.

CareDx, Inc.

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