CareDx Leads Scientific Evidence with Over 100 Peer-Reviewed Publications Supporting the Clinical Use of AlloSure and AlloMap for Organ 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 the five-year anniversary of AlloSure®, the groundbreaking, non-invasive donor-derived cell-free DNA (dd-cfDNA) surveillance solution used to measure allograft injury in solid organ transplant recipients. AlloSure along with AlloMap® represent disruptive innovations in the field of solid organ transplant.

“Prior to AlloSure’s introduction, dd-cfDNA was one of many non-invasive markers for organ rejection with the potential for clinical use. At the time, no one could have predicted the impact that it has achieved in just five years,” said Matthew R. Weir, MD, Attending Physician and Director of the Division of Nephrology in the Department of Medicine, University of Maryland School of Medicine and University of Maryland Medical Center. “CareDx led the way by demonstrating the value of dd-cfDNA by applying its extensive experience in organ transplant diagnostics to provide a clinically useful service with the power of dd-cfDNA to identify molecular signs of graft injury.”

“At CareDx, we are proud to have taken a leadership role in the field of transplant as very few companies are investing in transplant, let alone being 100 percent focused. Transplant is a lightly served area with research and development when compared to most other medical areas such as oncology, neurology and rare diseases. We have served this market, as the unmet need is significant, and it is estimated that one in five kidney transplants, one in three heart transplants, and one in two lung transplants are expected to fail five years post-transplant. There is an important need for highly sensitive and accurate biomarkers that can detect early injury and/or changes in immune quiescence,” said Reg Seeto, CEO and President of CareDx.

For more than twenty years CareDx has invested in transplant innovations to improve long-term allograft outcomes. This innovation has taken both significant financial investment and time to conduct multicenter, prospective studies versus relying only on single center or retrospective studies. In addition, CareDx has always conducted further clinical studies to build a robust scientific base of understanding for the transplant physician. Its tests are transplant specific and not repurposed from uses outside organ transplant.

Key highlights:

• CareDx is a scientific leader in transplant research and its testing services are the most extensively studied with over 100 peer-reviewed medical journal publications.
• CareDx’s two most studied organs are kidney with more than 55 publications, followed by heart with over 40 publications, 6 publications in lung, and 2 in liver. The most significant publications are listed on the company website.
• Since the introduction of AlloMap Heart in 2005, AlloSure Kidney in 2017, AlloSure Heart in 2020 as part of HeartCare, and AlloSure Lung in 2021, over 100,000 kidney, heart, and lung transplant patients have benefited from CareDx non-invasive testing services.
• Many of the leading transplant centers across the U.S. have independently established their own AlloMap and/or AlloSure surveillance testing protocols for heart, kidney, and lung transplant in their clinical practice based on the extensive published literature and their own experience of the services’ clinical value.

Added Reg Seeto, “As a reflection of our commitment and focus, we have invested more than $200 million dollars over the last three years into transplant research and development and notably, there have been more than 100 peer-reviewed publications supporting the use of AlloMap and AlloSure. This is a significant amount for a company of our size, yet we have made a commitment that every single research and development dollar is invested back into the transplant field with the goal to improve long-term outcomes.”

Since the launch of AlloSure, CareDx has also made a significant commitment to link the fragmented U.S. transplant ecosystem as patients traverse from pre- to peri- to post-transplant. Today, CareDx has the #1 medication discharge form in transplant patients, #1 quality management systems, #1 transplant downloaded app, #1 next-generation sequencing technology for HLA typing, in addition to being #1 in post-transplant biomarkers in heart, kidney and lung patients.

Furthermore, CareDx’ s commitment to the transplant community has included supporting important legislative policies such as the 21^st Century Cures Act to help bring new innovations to patients who need them faster, the Living Donor Protection Act to promote live organ donations and protect donors from discrimination, and most recently through its support of the “Honor the Gift Coalition,” helped to shepherd passage of the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019 (Immuno Bill). The Act allows patients to more easily maintain drug treatments essential for survival and preventing graft failure.

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 and AlloMap. 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 AlloSure and AlloMap; 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.

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