Addressing Health Inequities & Patient Advocacy

Partnership with MOTTEP to Support High-Risk Underserved Communities

CareDx joined forces with MOTTEP (Minority Organ and Tissue Transplant and Education Program) to help advance its mission of increasing the number of minority-donated organs and greater adoption of disease prevention behaviors which reduce the incidence of end-stage disease and the need for organ transplantation in high-risk, underserved communities.

MOTTEP’s mission is to reduce the rate and number of ethnic minority Americans needing organ and tissue transplants through disease prevention education and to increase minority organ donations to improve transplant success by finding better matches from similar minority ethnic groups.

CareDx Submits Letter to CMS in Response to Request for Transplant Patient Needs

The Centers for Medicare and Medicaid Services (CMS) requested Public Comments on the “Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities.” CareDx responded by conducting a survey with Its patient network, delivering insights from over 250 kidney, heart, lung, and liver transplant patients.

The survey identified four main areas for improvement to better support transplant patients across the continuum of care: 1) there is a need to create greater public awareness about the need for more registered organ donors to ensure a robust transplant ecosystem in the future; 2) more patient education is needed to prevent end-stage disease and improve post-transplant outcomes; 3) transplant patients are looking for ways to get on organ waitlists sooner; 4) patients are seeking greater financial assistance to help them manage chronic illnesses.

CareDx Advocates for Patients with Heart Failure & Heart Transplant by Partnering with HeartBrothers Foundation

CareDx is partnering again with the HeartBrothers Foundation a non-profit organization dedicated to helping patients with heart failure, including those receiving heart transplants, navigate their heart-related challenges. CareDx was HeartBrothers first corporate member and been a steadfast supporter since 2015. Its sponsorship has contributed to key achievements in 2021, including the launch of the HeartBrothers Patient Support Group, Heart Failure Awareness Campaign, and opening of HeartBrothers House.

Patient Education Webinars Conducted – Recordings Can Be Found Here

  • Optimizing For The Long-Term Success Of Transplant Patients
  • Ask the Experts: Post-Transplant Nutrition
  • Heart Health Across the Kidney Transplant Journey
  • COVID-19: Boosters, Antibodies & Continued Risk
  • Transplant Confessions: I Wish I Would Have Known

Product News, Studies, & Publications

Lung Transplantation

NIH Study Results for AlloSure® Lung Published in The Journal of Heart and Lung Transplantation

The results of a study led by the National Institutes of Health (NIH), published in The Journal of Heart and Lung Transplantation,1 “Donor-derived Cell-free DNA as a Composite Marker of Acute Lung Allograft Dysfunction in Clinical Care,” validates the ability of AlloSure Lung to detect signs of organ rejection and infection in asymptomatic lung transplant recipients in a real-world, home-based surveillance setting.  The use of AlloSure Lung also identified episodes of acute rejection and infection that would have been missed using a biopsy strategy alone.

The AlloSure Lung Clinical Utility Study was a real-world, multicenter, prospective study conducted from March 24 to September 1, 2020, at the height of the pandemic. Four lung transplant centers used AlloSure Lung donor-derived cell-free DNA (dd-cfDNA) instead of surveillance bronchoscopy for transplant rejection surveillance in a home-based setting using CareDx RemoTraC™, an at-home blood draw phlebotomy service.

The study showed that non-invasive AlloSure Lung effectively identified acute cellular rejection (ACR), antibody-mediated rejection (AMR), and infection in asymptomatic lung transplant patients during routine surveillance screening. For diagnosis of ACR, AMR, or infection in these patients, dd-cfDNA yielded a sensitivity of 73.9%, specificity of 87.7%, positive predictive value of 43.4%, and negative predictive value of 96.5%, with an area under the curve (AUC) of 0.82 using the ALARM investigator’s protocol. Using an AlloSure Lung surveillance strategy, there were 83% fewer invasive biopsies than would have been performed under a surveillance biopsy program.

Introduced in October 2021, AlloSure Lung has already been adopted in over 40% of lung transplant centers.2

Heart Transplantation

ISHLT Transplant Innovation Research Grant

CareDx partnered with the International Society for Heart and Lung Transplantation (ISHLT) in offering an Innovation Challenge Award to clinicians to further AlloSure and AlloMap research in support of patient care.

The ISHLT Innovation Challenge Award will support studies that evaluate the clinical utility of the combination of donor-derived cell-free DNA (dd-cfDNA) and gene expression profiling (GEP) in heart transplantation, or the utility of dd-cfDNA in lung transplantation. Selected finalists will be invited to present their research proposal at a specialized session at the ISHLT 2022 Annual Meeting & Scientific Sessions in Boston from April 27-30, 2022. The winner will be determined by a panel of expert, on-site judges.

Xenotransplantation

CareDx Introduces XenoSure & XenoMap for Xenotransplantation Research

XenoSure™ donor-derived cell-free DNA (dd-cfDNA) and XenoMap™ gene-expression profiling are now available for investigational use in xenotransplantation research and post-xenotransplant clinical monitoring.  These products represent the world’s first surveillance solutions for investigational use in xenotransplantation.

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.

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.

Xenotransplantation Innovation Day Held

CareDx brought together leading transplant experts to share latest advancements in the field of xenotransplantation after genetically modified pig kidneys and, separately a pig heart, were recently successfully transplanted, two medical firsts.

The event included an update from Muhammad M. Mohiuddin, MD, Professor of Surgery and Scientific Director of the Program in Cardiac Xenotransplantation at the University of Maryland School of Medicine who co-led the world’s first successful living pig-to-human heart xenotransplant and an update from Robert A. Montgomery, MD, DPhil, Professor and Chair of the Department of Surgery and Director of the Transplant Institute, NYU Langone Health, and surgeon who performed the world’s first successful kidney xenotransplant. Recent developments of clinical-grade, human-compatible organs, and cells were provided by eGenesis and Miromatrix.

Opening remarks were delivered by professional and patient society leaders including: American Society of Transplant Surgeons (ASTS), A. Osama Gaber, MD, President-Elect; National Kidney Foundation, Paul M. Palevsky, MD, President; The International Society for Heart and Lung Transplantation (ISHLT), Andreas Zuckermann, MD, President-Elect; and Transplant International Organization (TRIO), James Gleason, President and heart transplant recipient.

Professional Society Meetings & Webinars

CEoT Symposium Featured Latest Multimodality Innovations in Kidney & Lung Transplant Surveillance

CareDx hosted the symposium, “Improved Precision with a Multimodality Approach,” during the annual American Society of Transplantation Cutting Edge of Transplantation (CEoT) on Thursday, April 7. The latest advancements in multimodality surveillance using CareDx’s AlloSure donor-derived cell-free DNA (dd-cfDNA), AlloMap gene-expression profiling, and other new emerging modalities for assessing allograft injury, rejection, and infection in kidney and lung transplantation were presented.

Professional Education Webinars Conducted – Recording Can Be Found Here

  • Optimizing For The Long-Term Success of Transplant Patients
  • Managing Your Outcomes in a World of Imperfect Organs and Higher Risk Recipients – Two Parts
  • Score 6 Advanced Options and Troubleshooting Tips – Fast Results with Automated Analysis
  • AlloSeq HCT – The Latest Innovation in NGS-based Chimerism Testing

Company News

CareDx Acquires The Transplant Pharmacy, Expanding Medication Adherence Services

CareDx acquired The Transplant Pharmacy, a transplant focused pharmacy, to expand its medication management and adherence services. The Transplant Pharmacy provides individualized transplant pharmacy services for patients at multiple transplant centers located throughout the United States. Dedicated to patient service and medication adherence, the pharmacy also offers an online patient portal and mobile app for medication ordering and reminders.

The acquisition of The Transplant Pharmacy expands CareDx’s medication adherence-focused healthcare solutions for patients, which currently includes products such as: AlloCare®, a comprehensive mobile health app for managing the day-to-day health of patients pre- and post-transplant; Transplant Hero™, a pill reminder app; and MedActionPlan®, a robust medication management and adherence platform used by more than 100 healthcare systems.

CareDx Wins $44.9M in Damages in False Advertising Trial Against Natera

The jury found that Natera intentionally and recklessly misled the transplant community by deliberately engaging in false advertising in the promotion and marketing of its Prospera kidney transplant rejection assessment test. CareDx was awarded monetary damages totaling $44.9M: $21.2M in compensatory damages and $23.7M in punitive damages.

Overwhelming evidence emerged at trial that demonstrated that Natera made false statements that its senior executives knew were based on unscientific, unreliable, and inappropriate conclusions to market Prospera. The trial underscored the value of AlloSure®’s clinical excellence as the only donor-derived cell-free DNA (dd-cfDNA) test that has prospective, multicenter validation published. The jury did not find CareDx liable for false advertising under the Delaware Deceptive Trade Practices Act, or intentional and willful false advertising or unfair competition. Notably, the jury rejected all of Natera’s challenges to AlloSure performance claims.

The jury found Natera liable for false advertising based on Natera’s false comparisons of its kidney transplant assessment test, Prospera, to CareDx’s market leading AlloSure technology. Specifically, the jury found Natera liable for: 1) false advertising under the Lanham Act; 2) false advertising under the Delaware Deceptive Trade Practices Act; 3) Intentional and willful engagement in false advertising; and 4) Intentional or reckless engagement in unfair competition.

Global Outreach

CareDx Partners with the ESOT to Support the Use of AlloSeq cfDNA in Europe

CareDx is partnering with the European Society for Organ Transplantation (ESOT) to provide education for its membership on the clinical evidence supporting the use of donor-derived cell-free DNA (dd-cfDNA) to monitor transplanted organ health.

CareDx’s partnership with the European Society for Organ Transplantation represents a key step forward in educating the European transplant community about the clinical utility of AlloSeq cfDNA, its kit version to allow donor-derived cell-free DNA assessment. Over time this may help expand access to this leading technology, and make it the standard of care for organ transplant patients globally.

References:

1. Keller M, Sun J, Mutebi C, et al. Donor-derived Cell-free DNA as a Composite Marker of Acute Lung Allograft Dysfunction in Clinical Care. The Journal of Heart and Lung Transplantation. December 26, 2021. DOI: https://www.jhltonline.org/article/S1053-2498(21)02630-9/fulltext
2. CareDx data on file. March 31, 2022.