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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) showcased its AlloSure surveillance tool during the virtual ASN annual conference from October 22-25, 2020, reflecting increasing interest from nephrologists.
Eleven abstracts highlighting AlloSure were presented, underscoring its significance in transplant patient management. The company also sponsored an educational symposium titled Diagnostic Controversies in Transplantation. Notably, real-world data from over 1,000 patients will be shared, showing positive clinical outcomes associated with the AlloSure tool.
CareDx announces that the Centers for Medicare and Medicaid Services (CMS) has recommended continued coverage of AlloMap for heart transplant patients via local Medicare Administrative Contractors (MACs). This follows a memo acknowledging multiple studies demonstrating AlloMap's clinical utility since its initial request for a national coverage determination in 2013. AlloMap, adopted by over 90% of U.S. transplant centers and supported by ISHLT guidelines, continues to receive reimbursement, affirming its status as the standard of care in transplant medicine.
CareDx, Inc. (CDNA) announced its participation in the virtual 46th annual ASHI conference, taking place from October 19-21, 2020. The company will showcase its latest innovations for HLA laboratories, including a symposium led by Dr. Rajalingam Raja on October 20, highlighting the AlloSeq Tx17 HLA typing solution. Presentations and posters will cover various advancements in HLA typing, including hybrid capture techniques and genetic risk factors in transplantation. CareDx aims to strengthen community engagement and share updates on best practices in transplant patient care.
CareDx, Inc. (Nasdaq: CDNA) will release its third-quarter 2020 financial results on October 29, 2020, after market close. The conference call to review these results will be hosted by CEO Peter Maag and CFO Michael Bell at 1:30 PM PT. Interested parties can join the call by dialing 877-705-6003 or via webcast on CareDx's investor relations page. A replay will be available from October 29 at 4:30 PM PT until November 12, 2020. CareDx specializes in precision medicine for transplant patients.
CareDx, Inc. (CDNA) announced a preliminary revenue of approximately $53.0 million for Q3 2020, a 57% increase from $33.8 million in Q3 2019. This growth was driven by testing revenue of $45.2 million, up from $28.2 million year-over-year. Notably, around 21,800 AlloSure and AlloMap tests were conducted during the quarter. The company emphasizes its commitment to supporting transplant patients amid the pandemic and continues to invest in growth and digital solutions for enhanced patient care.
CareDx, Inc. (Nasdaq: CDNA) announced pivotal clinical data publications for AlloSure Lung, a non-invasive biomarker for acute cellular rejection (ACR) in lung transplant patients. The LARGO study, involving 69 patients, demonstrated AlloSure's effectiveness in identifying ACR without invasive procedures. Additionally, the University of Texas San Antonio published findings from a cohort of 48 patients, emphasizing the tool's value for monitoring allograft dysfunction, especially during the COVID-19 pandemic. Experts highlight AlloSure Lung as a promising advancement in transplant care.
CareDx, Inc. (Nasdaq: CDNA) announced the release of a final local coverage determination by Palmetto MolDx for AlloSure Heart, a dd-cfDNA test identifying cell injury that leads to organ rejection. Medicare reimbursement for this test follows a thorough technical assessment, highlighting its clinical utility in transplant management. This decision facilitates the launch of HeartCare, which combines AlloSure Heart with AlloMap Heart, offering a comprehensive, non-invasive solution for heart transplant patients during the COVID pandemic. This coverage enhances patient access and optimizes care management.
CareDx, Inc. (Nasdaq: CDNA) launched AlloCare, a mobile app aimed at enhancing medication adherence and health management for transplant patients. The app will debut at the AlloCare Transplant Festival on September 26, 2020, designed to foster connections within the transplant community. The festival will feature notable personalities and over 25 transplant organizations, emphasizing CareDx's commitment to improving long-term outcomes through innovative patient engagement solutions. The app is now available for download in the Apple App Store.
CareDx, Inc. (CDNA) announced its participation in the 28th International Congress of The Transplantation Society (TTS) from September 13-16, 2020. The company will showcase its AlloSure and AlloSeq cfDNA tools through four virtual symposia and six poster presentations. Expert speakers will discuss topics like risk prediction in kidney transplantation and the use of dd-cfDNA as a biomarker. CareDx aims to support continuous education for the transplant community and emphasize innovations in transplant medicine.
CareDx, Inc. (NASDAQ: CDNA), a precision medicine leader, has appointed new senior executives in key areas: Digital Services, Laboratory Operations, Business Development, and Market Access. The appointments aim to enhance operational efficiency amidst rapid growth. Notable new hires include Kashif Rathore, Ryan Phan, Sean Grant, and Danielle Scelfo, each bringing extensive experience from leading companies. CEO Peter Maag emphasizes the need for robust leadership to navigate increasing operational complexities and advance CareDx's market strategies.
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