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CareDx, Inc. reports developments in precision medicine for transplant patients and caregivers. The company’s updates center on non-invasive molecular testing for heart, kidney, and lung transplantation, including AlloSure, AlloMap, HeartCare, and related evidence generation for post-transplant surveillance, risk assessment, and longitudinal patient management.
CareDx news also covers operating and financial results for testing services and patient and digital solutions, product and platform launches such as VANTx clinical data analytics, clinical conference presentations, material agreements, and Nasdaq-related governance matters including inducement equity awards.
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.
CareDx, focused on transplant healthcare solutions, reported Q4 2021 revenue of $79.2 million, a 35% increase year-over-year. Full-year revenue reached $296.4 million, up 54% from 2020. Testing services revenue in Q4 was $68.6 million, while product revenue was $7.7 million. Despite the revenue growth, the company experienced a net loss of $16.2 million in Q4, compared to a loss of $3.5 million in Q4 2020. CareDx aims for 2022 revenues between $330 million and $350 million.
CareDx’s Non-Invasive Blood Tests Revolutionize Organ Health Monitoring
CareDx, Inc. (CDNA) announced that its non-invasive organ transplant surveillance solutions are being utilized in the world's first successful heart xenotransplantation at the University of Maryland Medical Center, performed on January 7, 2022. These innovative tests aid in assessing graft health through gene expression profiling and donor-derived cell-free DNA analysis. CareDx's commitment to transplant patients is highlighted by its established solutions utilized by over 90% of heart transplant centers in the U.S., addressing an urgent organ shortage.