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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, 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.
CareDx, Inc. (Nasdaq: CDNA) announced it will release its financial results for Q4 and the full year 2021 on February 24, 2022, after market close. A conference call will follow at 1:30 PM PT / 4:30 PM ET. Interested participants can listen by calling 855-327-6837 in the U.S. or 631-891-4304 internationally, referencing Conference ID: 1001789, or via a live webcast on their investor relations website.
CareDx, Inc. (CDNA) has announced its commitment to raising awareness for organ donation on National Donor Day, February 14. With over 100,000 Americans waiting for organ transplants, the company supports advocacy groups like Donate Life America and the National Kidney Foundation. CEO Reg Seeto emphasized the importance of legislative efforts, including the Living Donor Protection Act, to promote organ donation. The company aims to influence public awareness about organ donations and address critical unmet needs in the transplant community.
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