CareDx Leads Transplant Innovation with AiKidney, an AI Clinical Decision Support Tool for Predicting Allograft Rejection Risk

Data from AiKidney Helps Clinicians Gain New Insights into Patient’s Risk of Allograft Rejection

CareDx to Host Investor Event to Share More Information About AiKidney, Clinical Pipeline and Using Augmented Information in Transplantation

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 plans to expand its growing multimodality portfolio with AiKidney™, a new allograft risk assessment clinical decision support tool, in development, that includes AlloSure® and other transplant metrics.

This follows CareDx’s recently announced plans to add an artificial intelligence (AI) prognostic for cardiac allograft vasculopathy (CAV). Presentations covering these developments will occur during the 2022 Transplant Congress on June 4-8 in Boston, Massachusetts.¹

AiKidney delivers information about a patient’s current risk of rejection and a prognosis of allograft survival at three, five, and seven years. AiKidney can be used for informing clinical management decisions and to help clinicians predict the long-term impact of treatments. As transplant patient care becomes more complex, with an increasing focus on optimizing immunosuppression and long-term care, AlloSure is the only donor-derived cell-free DNA (dd-cfDNA) solution that features this additive AI-enabled risk assessment algorithm.

“CareDx is driving the next wave of transplant innovation with multimodality that amplifies the power of AlloSure by incorporating artificial intelligence.² AiKidney has the potential to set a new standard of care through precision medicine by generating new insights to support earlier interventions or to modulate immunosuppression when assessing the risk of rejection by physicians,” said Reg Seeto, CEO and President of CareDx. “This approach aligns very much with our mission of improving long-term outcomes through innovative solutions.”

“We’re proud to work with CareDx to apply innovative digital health solutions to drive earlier data-driven interventions with molecular precision,” said Dr. Alex Loupy, Founder of OrganX. “This ongoing partnership is yielding positive results and it is exciting to see AiKidney coming to fruition in the clinic.”

“Studies have shown the effectiveness of CareDx’s multimodality solutions for routine kidney transplant surveillance and for identifying immune-quiescence,”^3-5 said Miklos Z. Molnar, MD, PhD, Professor of Medicine and Medical Director of Kidney and Pancreas Transplantation at University of Utah. “AiKidney supports this assessment by providing information about a patient’s risk of allograft rejection and expected long-term graft survival. I am excited with innovations such as this one that have the potential to help prolong kidney allograft survival which remains suboptimal at the 10-year mark. “

Transplant Congress Presentations Highlight the Utility of AI-Enabled Risk Assessments:

• CareDx Product Theatre: The Predictive Power of AlloSure and AiKidney, Sunday, June 5, 9:30–10:00 am ET, Theatre A, Exhibit Hall C

• CareDx Lunch Symposium: A Window to a New World: Multi-Modality Molecular Characterization & Prediction of Allograft Outcomes, Tuesday, June 7, 12:45 – 1:45pm ET.

For detailed agendas for the product theatre and lunch symposium, please go to the CareDx website and follow this link.

CareDx Innovation Day:

• Artificial Intelligence in Transplantation and CareDx Clinical Pipeline, Tuesday, June 7, 2:00 -3:00pm ET. The event will be held in a hybrid format to enable a wide audience to participate. To learn more and sign up, register here.

Long-term kidney transplant failure is a serious issue and begins to accelerate three years post-transplantation. Kidney failure rates⁶ are approximately 15 percent at three years, 21 percent at five years and 48 percent at ten years.⁷ Graft injury and rejection are the main reasons for transplant failures, excluding death. Adding to the problem is a serious kidney organ shortage. Over 90,000 Americans are on the waiting list for a kidney transplant, and about 13 people die each day waiting for one.⁸ Conventional kidney transplant biomarkers (e.g. serum creatine) are lagging indicators of kidney transplant rejection. Innovations from CareDx have the potential to inform earlier, data-driven interventions which have the potential to improve long-term outcomes.

Note: The product theater, symposium, and investor innovation day are not part of the official American Transplant Congress (ATC) educational program, and the sessions and content are not endorsed by ATC.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 AiKidney. 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 AiKidney; risks that the agendas of CareDx presentations highlighting AI-enabled risk assessment in transplantation fail to take place as planned; 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.

References:

1. The product theaters, symposium, and investor innovation day are not part of the official American Transplant Congress (ATC) educational program, and the sessions and content are not endorsed by ATC.
2. Aubert O, Brousse R, Juliette Gueguen J, et al. FC 113: Development and Validation of an Integrative DD-CFDNA System to Predict Allograft Rejection: A Population Based Study, Nephrology Dialysis Transplantation, Volume 37, Issue Supplement_3, May 2022, gfac123.002, https://doi.org/10.1093/ndt/gfac123.002
3. Bu L, Gupta G, Pai A, et al, Validation and clinical outcome in assessing donor-derived cell freeDNA monitoring insights of kidney allografts with longitudinal surveillance (ADMIRAL) study., Kidney International (2022), doi: https://doi.org/10.1016/j.kint.2021.11.034.
4. Cheung R, Xu H, Jin X, et al. Validation of a gene expression signature to measure immune quiescence in kidney transplant recipients in the CLIA setting. Biomarkers in Medicine. Published Online: 29 Apr 2022. https://doi.org/10.2217/bmm-2022-0113
5. Akalin E, Weir MR, Bunnapradist S, et al. Clinical Validation of an Immune Quiescence Gene Expression Signature in Kidney Transplantation. Kidney360. December 2021, 2 (12) 1998-2009; DOI: https://doi.org/10.34067/KID.0005062021
6. Deceased kidney organ donations.
7. Hart A, Lentine KL, Smith JM,et al. OPTN/SRTR 2019 Annual Data Report: Kidney. Am J Transplant. 2021 Feb;21 Suppl 2:21-137. doi: 10.1111/ajt.16502. PMID: 33595191.
8. UNOS Website. https://www.srtr.org/reports/optnsrtr-annual-data-report/ accessed May 30 2022

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