CareDx Celebrates 1 Million Organ Transplants and 100,000 Patient Milestone

One out of Ten Patients Served by CareDx

Signals Broad Uptake of Company’s Non-Invasive Testing Services for Heart, Kidney, and Lung Transplant 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 that it has served its 100,000th transplant patient, representing one out of ten patients transplanted in the U.S. This milestone demonstrates strong clinical adoption of molecular surveillance for transplant patients and showcases AlloMap® and AlloSure® as leading tools which are becoming firmly embedded in post-transplant patient care.

“We celebrate the one millionth organ transplant patient in the U.S., a historical milestone reported by UNOS that represents countless saved lives. At CareDx we are extremely proud to have achieved our own milestone in serving 100,000 patients and one out of ten patients transplanted in the U.S.,” said Reg Seeto, CEO and President of CareDx. “This is a testament to our dedicated, 100 percent commitment to transplantation, and leading innovation with AlloSure and AlloMap.”

“I’ve been a strong proponent of CareDx’s non-invasive testing services, and it is exciting to see their growing use in kidney transplantation,” said Tarek Alhamad, MD, Medical Director, Kidney Transplant Program, Barnes Jewish, Washington University. “It is truly remarkable to see how post-transplant care is evolving, and I am excited, along with other clinicians in the field, to see how the company’s imminent multimodal KidneyCare offering will help us better risk stratify allograft injury to proactively manage this condition, and potentially to reduce the need for biopsy.”

CareDx AlloMap gene-expression profiling (GEP) was made commercially available in 2005 and AlloSure donor-derived cell-free DNA (dd-cfDNA) in 2017, both becoming the most widely used non-invasive tests of their kind to identify immune quiescence and the risk of graft injury in transplant recipients. AlloMap Heart is used in more than 90 percent of the nation’s heart transplant centers and in more than 1 in 2 newly transplanted patients.¹ In 2020, CareDx launched HeartCare, which includes both AlloMap and AlloSure, and currently accounts for over 90 percent of AlloMap use.¹ AlloSure Kidney is used in 70 percent of kidney transplant centers and 1 in 3 newly transplanted patients.¹ AlloSure Lung is used in over 50 percent of lung transplant centers and has been used in over 1,400 patients.¹

“Simply put, the rapid uptake of CareDx’s non-invasive testing services is a testament to the value clinicians place on these molecular solutions to drive earlier data-driven interventions,” said Nirav Raval, MD, Thoracic Transplant Director, Florida Hospital Transplant Institute, Advent Health. “I look forward to the company’s addition of artificial intelligence to its molecular offerings. This will be a game changer because in the future, we will be able to personalize care even further by being able to not only identify, assess and manage rejection but also treat based on knowing a patient’s risk of Cardiac Allograft Vasculopathy (CAV).”

Eugene DePasquale, MD, Medical Director, Heart Transplant Program, Keck Medicine, USC, adds, “AlloSure dd-cfDNA has accelerated the shift from traditional heart surveillance biopsies to ‘for cause’ biopsy -- dd-cfDNA is being evaluated for incorporation into ISHLT guidelines and once added will only amplify the value of AlloMap, which is already in guideline, as an integral part of heart transplant care.”

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 AlloMap, AlloSure, and CareDx’s processing of transplant tests on patients. 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 AlloMap, AlloSure, or CareDx’s processing of transplant tests on patients; risks that CareDx may not repeat the same success as it introduces other disruptive innovations using artificial intelligence and multimodal assessments; risks that KidneyCare may not be eventually commercialized; 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, 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.

References:

1. CareDx data on file. September 13, 2022.

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