Welcome to our dedicated page for Caredx news (Ticker: CDNA), a resource for investors and traders seeking the latest updates and insights on Caredx stock.
CareDx, Inc. (CDNA) operates at the forefront of transplant medicine, where product innovations, clinical trial results, and regulatory developments drive significant news flow. As a precision diagnostics company focused on organ transplantation, CareDx generates news related to clinical study publications, FDA and regulatory interactions, reimbursement policy changes, and product commercialization milestones. This news page provides comprehensive coverage of developments affecting the company's transplant surveillance and HLA typing businesses.
The types of news that matter most for CareDx include peer-reviewed study publications demonstrating clinical utility of its dd-cfDNA technology, Medicare coverage determinations that impact reimbursement for surveillance testing, product launches expanding into new transplant types or international markets, and earnings reports revealing testing volume trends. Additionally, significant 8-K filings may disclose material events such as partnership agreements with transplant centers, changes in reimbursement policies, or intellectual property developments. Understanding these news categories helps investors track the company's progress in validating its technology platform and expanding commercial adoption.
CareDx's news flow reflects the biotech and diagnostics industry's focus on evidence generation and regulatory milestones. Clinical data presentations at major transplant medicine conferences like the American Transplant Congress and American Society of Nephrology provide insights into product performance and physician adoption trends. Regulatory submissions for expanded product indications, international certifications, and coverage policy updates from insurers represent critical catalysts that can accelerate or constrain market penetration for the company's diagnostic services.
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.
CareDx, Inc. (Nasdaq: CDNA) submitted insights from over 250 transplant patients to the Centers for Medicare and Medicaid Services (CMS) regarding the Health and Safety Requirements for transplant programs. This initiative reflects CareDx's commitment to advocating for patient needs. The survey identified key areas for improvement, including increasing organ donor awareness, enhancing patient education, expediting waitlist processes, and providing greater financial assistance. CareDx continues to support legislative policies beneficial to transplant patients, solidifying its role as a leader in transplant care solutions.
CareDx has announced a webinar on February 10, 2022, aimed at educating kidney transplant patients, particularly from underrepresented minorities, about maintaining optimal heart health to prevent cardiovascular complications that can lead to transplant failure. The event, in partnership with MOTTEP, will feature expert panelists discussing critical topics, including organ waitlists and managing post-transplant health. The initiative coincides with Black History Month and Heart Month, emphasizing equity in organ transplantation.
CareDx, Inc. (Nasdaq: CDNA) announced its participation in two upcoming conferences: the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 16, 2022, at 1:00 PM ET and the Raymond James 43rd Annual Institutional Investors Conference on March 7, 2022, at 11:35 PM ET. Interested parties must contact BTIG representatives to access the first event, while the second will be available via a webcast on CareDx's investor relations website. CareDx specializes in healthcare solutions for transplant patients.
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