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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) 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.
CareDx, Inc. (CDNA) has partnered with MOTTEP to enhance minority organ donations and promote disease prevention in underserved communities. This collaboration aims to address health disparities and improve organ transplant outcomes for minority patients, who make up 60% of the U.S. organ transplant waiting list. The partnership will fund educational initiatives to encourage organ registry sign-ups and emphasize the significance of medication adherence post-transplant. CareDx seeks to bridge gaps in healthcare access and patient care for historically underrepresented populations.
CareDx, Inc. (CDNA) announced the publication of results from the ADMIRAL study, demonstrating that its AlloSure® Kidney test effectively detects both clinical and subclinical allograft injuries in kidney transplant patients. The multicenter study, which monitored 1,092 patients, showed a 62% improvement over standard serum creatinine in identifying rejections. AlloSure correlated with a 271% increased risk of donor-specific antibody formation and can predict long-term graft survival. These findings highlight AlloSure's potential to transform transplant care and enhance patient outcomes.
CareDx, Inc. (Nasdaq: CDNA) announced collaborations with three leading biopharmaceutical companies to incorporate its AlloCell surveillance solutions in ongoing CAR T-cell therapy clinical studies. AlloCell serves as a next-generation sequencing tool to monitor the expansion and persistence of allogeneic cell therapies in cancer patients. The potential market for AlloCell in oncology is estimated over $5.5 billion. This initiative reflects CareDx's commitment to advancing cell therapy research and improving patient outcomes.
CareDx, Inc. (Nasdaq: CDNA) reported preliminary financial results for Q4 and full year 2021, showcasing significant growth. Q4 revenue is projected between $78.6 million and $79.0 million, up 34% to 35% year-over-year, with over 41,900 tests conducted. Full year revenue is anticipated to be between $295.7 million and $296.1 million, reflecting a 54% increase from 2020. The company achieved CLIA validation for AlloMap Kidney and completed five acquisitions, strengthening its market position. Cash reserves stood at $348 million as of December 31, 2021.
CareDx, Inc. announced significant findings from the ALARM study published in The Journal of Heart and Lung Transplantation. The study validates the efficacy of AlloSure Lung for non-invasive monitoring of lung transplant recipients during the COVID-19 pandemic. Conducted across four centers, it showed that AlloSure can detect acute rejection and infection with a sensitivity of 73.9% and specificity of 87.7%. Notably, using this method reduced invasive biopsies by 83%. These advancements highlight a safer and effective approach for transplant patient surveillance.
CareDx, Inc. (CDNA) announced the successful completion of CLIA validation for AlloMap Kidney, a blood-based gene expression classifier identifying immune quiescence, crucial for assessing rejection risk and allograft health. The clinical validation indicates AlloMap Kidney can differentiate between rejection types and immune quiescence, achieving a combined area under the curve (AUC) of 0.894. This validation is a significant step toward commercializing the KidneyCare multimodality solution, enhancing monitoring for kidney transplant health.
CareDx Acquires The Transplant Pharmacy to Enhance Support for Organ Transplant Patients. Located in Flowood, Mississippi, The Transplant Pharmacy specializes in individualized medication management services for transplant patients across the U.S. This acquisition strengthens CareDx’s connection with patients and expands its portfolio, which includes AlloCare™, Transplant Hero™, and MedActionPlan. CEO Reg Seeto emphasized the importance of medication adherence in improving patient outcomes. The acquisition aims to deliver personalized pharmaceutical care, ultimately benefiting organ transplant recipients.
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