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CareDx, Inc. (NASDAQ: CDNA) is at the forefront of transforming transplant patient care through its innovative surveillance management solutions. Dedicated to improving the lives of organ transplant patients, CareDx leverages the latest in genomics and bioinformatics technology combined with rigorous clinical evidence derived from trials and registries.
CareDx offers a suite of precision medicine solutions aimed at enhancing both pre- and post-transplant care. One of its flagship products, AlloSure®, is the first and only non-invasive blood test that directly measures allograft injury. This next-generation sequencing (NGS) based test detects donor-derived cell-free DNA (dd-cfDNA), providing clinicians with a powerful tool to identify organ injury and the probability of active rejection, particularly in kidney transplant patients.
The company's portfolio also includes AlloMap Heart, AlloSure Heart, and AlloSure Lung, which are dd-cfDNA solutions designed for heart and lung transplant recipients. These products underscore CareDx’s commitment to offering clinically differentiated, high-value healthcare solutions that span the entire transplant journey.
CareDx generates the majority of its revenue from the United States, with a significant portion coming from its testing services. Its product suite not only addresses the critical needs of transplant patients but also supports healthcare providers in delivering better patient outcomes through genomics-based information.
Recent achievements include the continued expansion of their product line and partnerships with leading healthcare institutions to further validate and implement their innovative diagnostic solutions. These efforts position CareDx as a leader in the field of transplant diagnostics and surveillance.
CareDx Hosts Innovative Symposium on Transplant Health
SOUTH SAN FRANCISCO, Calif., April 6, 2022 – CareDx, Inc. (Nasdaq: CDNA) announces its symposium, “Improved Precision with a Multimodality Approach,” at the American Society of Transplantation’s CEoT meeting, April 6-8. The event on April 7 will discuss multimodality surveillance advancements using AlloSure® dd-cfDNA and AlloMap® gene-expression profiling for kidney and lung transplants. NYU Langone Health's abstract on dd-cfDNA stability post-SARS-CoV-2 vaccination reinforces vaccine safety in kidney transplant recipients.
CareDx, Inc. (Nasdaq: CDNA) has partnered with the European Society for Organ Transplantation (ESOT) to enhance education regarding the use of donor-derived cell-free DNA (dd-cfDNA) in monitoring transplanted organ health. This collaboration aims to promote AlloSeq cfDNA, which provides insights into allograft injury and rejection risk. Both organizations emphasize the importance of non-invasive monitoring technologies for improving transplant outcomes. CareDx plans to leverage this partnership to expand the adoption of its technologies across Europe.
CareDx, Inc. (Nasdaq: CDNA) announced its partnership with the HeartBrothers Foundation to host a patient education webinar on navigating heart transplantation. This event will take place on March 31, 2022, and aims to provide insights into the transplant journey through personal stories and information on non-invasive post-transplant surveillance. CareDx highlights its commitment to supporting heart failure patients and promotes its AlloMap® Heart product, utilized by over 90% of heart transplant centers. The partnership underscores CareDx's dedication to enhancing patient education and support in the transplant community.
CareDx, Inc. (Nasdaq: CDNA) has enhanced its AlloCare® mobile app with a new “virtual roadmap” feature aimed at assisting kidney failure patients in managing the transplant waitlist process. Historically, only 13.5% of the 550,000 U.S. dialysis patients are on waiting lists, largely due to the complex requirements. The new feature, integrated with the TxAccess™ tool, allows pre- and post-transplant patients to connect with healthcare providers and track essential steps. Since its launch in 2020, AlloCare has been downloaded over 25,000 times, offering valuable health metric tracking and support.
CareDx, Inc. (Nasdaq: CDNA) has launched XenoSure™ and XenoMap™, the world’s first surveillance solutions for investigational use in xenotransplantation research and post-transplant clinical monitoring. These non-invasive tests assess organ graft health, with XenoSure detecting graft injury and XenoMap evaluating immune status. Used during a historic pig-to-human heart transplant at the University of Maryland, these innovations mark a significant advancement in transplant diagnostics. CareDx aims to enhance long-term outcomes for transplant patients through continuous innovation.
CareDx Wins False Advertising Case Against Natera
CareDx (Nasdaq: CDNA) has successfully won a false advertising lawsuit against Natera (Nasdaq: NTRA), with the jury awarding CareDx $44.9 million in damages. The jury found that Natera engaged in false advertising regarding its Prospera kidney transplant rejection assessment test, misleading the transplant community. CareDx's AlloSure technology was upheld as the trusted standard in this domain. This ruling reinforces CareDx's commitment to scientific integrity and patient care in the transplant sector.
CareDx, Inc. (Nasdaq: CDNA) announced a virtual “Xenotransplantation Innovation Day” set for March 22, 2022. This event will feature prominent transplant experts discussing breakthroughs in xenotransplantation, including successful transplants of genetically modified pig organs. Notably, it will include updates from the University of Maryland on the first living pig-to-human heart transplant and NYU Langone on the first gene-edited pig kidney transplant. CareDx aims to enhance transplant outcomes and address the organ shortage crisis, with critical discussions on advancements in bioengineered organs.
CareDx Wins False Advertising Case Against Natera
In a landmark ruling on March 14, 2022, CareDx (CDNA) secured a significant victory against Natera (NTRA), with a jury awarding CareDx $44.9 million for false advertising related to Natera's kidney transplant assessment test, Prospera. The jury found Natera liable for intentional false advertising and unfair competition, highlighting misleading statements made by its senior executives. CareDx's AlloSure technology, the only FDA-validated dd-cfDNA test for transplant surveillance, remains a standard of care in over 150 U.S. centers.
CareDx announces the initiation of the CIBIL clinical trial in partnership with Cibiltech to assess the iBox AI algorithm for kidney transplant patient management. The trial aims to include 450 patients to evaluate the clinical and economic benefits of iBox in predicting organ survival. CareDx is a minor stakeholder in Cibiltech and holds exclusive commercialization rights for iBox in the U.S. The company is also leveraging iBox within its OKRA study, enhancing its suite of transplant monitoring tools.
CareDx, Inc. (Nasdaq: CDNA) is collaborating with the National Kidney Foundation to mark National Kidney Month by supporting initiatives aimed at improving outcomes in kidney care. This partnership continues a seven-year commitment to advocate for kidney disease awareness, including legislative efforts for funding research on chronic kidney disease (CKD). Notably, the company is co-hosting an educational webinar on March 15, focusing on innovations in kidney care, which aims to aid patients in their healthcare journey.