CareDx Leads the Way in Xenotransplant Organ Surveillance in Monitoring World's First Successful Living Xenotransplantation

SOUTH SAN FRANCISCO, Calif., Feb. 22, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. 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 its non-invasive organ transplant surveillance solutions are being used to help monitor post-operative graft health in the world's first successful heart xenotransplantation. A genetically modified pig heart was successfully transplanted into a patient at the University of Maryland Medical Center on January 7, 2022.

Surgeons from the University of Maryland School of Medicine (UMSOM) are using adapted versions of two complementary, non-invasive CareDx surveillance solutions, experimentally, to provide a comprehensive, multimodal assessment of organ graft health. Gene expression profiling is being used to assess immune quiescence and donor-derived cell-free DNA (dd-cfDNA) to detect graft injury.

"As an innovator in organ transplant surveillance, CareDx is proud to be working with UMSOM on this landmark case which represents a groundbreaking moment in the history of transplantation," said Reg Seeto, CEO and President of CareDx. "It's incredibly rewarding to apply our years of experience and dedication to the transplant community by offering the world's first biomarker surveillance solution for xenotransplantation. We look forward to continuing to work closely with surgeons at UMSOM and the extended care team at the University of Maryland Medical Center to help ensure long-term success for this patient."

"We are taking every precaution to ensure the optimal care of the world's first successful transplantation of a genetically modified pig heart, including using CareDx's non-invasive multimodality surveillance solutions to help monitor graft health," said Dr. Bartley P. Griffith, Professor of Surgery and Clinical Director of the Cardiac Xenotransplant Program at UMSOM. Dr. Muhammad Mohiuddin, Professor of Surgery and Scientific Director of the Program in Cardiac Xenotransplantation at UMSOM, co-led the procedure with Dr. Griffith.

There is an organ shortage in the U.S. While most Americans support organ donation, only 58 percent are registered as organ donors.¹ There is a great need for more donors with more than 100,000 Americans on the national transplant waiting list, and nearly 20 people die each day waiting for an organ transplant.² Xenotransplantation may offer an alternative for people in need of a life-saving organ.

CareDx is dedicated to driving innovation in the transplant field. 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 and kidney transplant patients. CareDx has served over 80,000 organ transplant patients with its AlloSure or AlloMap assays for their post-transplant care. 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' organ health.³

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 CareDx's surveillance solutions. 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 its surveillance solutions; risks that CareDx ceases work with the University of Maryland Medical Center and the extended care team; 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, 2020 filed by CareDx with the SEC on February 24, 2021, the quarterly report on Form 10-Q for the first quarter of 2021 ended on March 31, 2021 filed by CareDx with the SEC on May 5, 2021, the quarterly report on Form 10-Q for the second quarter of 2021 ended on June 30, 2021 filed by CareDx with the SEC on July 29, 2021, the quarterly report on Form 10-Q for the third quarter of 2021 ended on September 30, filed by CareDx with the SEC on October 28, 2021, 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. LifeCenter. The Organ Shortage & the Need for Donors. Available at https://lifepassiton.org/the-organ-shortage-the-need-for-donors/. Accessed online February 16, 2022.
2. Health Resources & Services Administration (HRSA). Available at https://www.organdonor.gov/learn/organ-donation-statistics/. Accessed online February 16, 2022.
3. CareDx data on file. January 31, 2021