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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) announced the completion of its leadership transition from Peter Maag, PhD, to Reginald Seeto, MBBS, as Chief Executive Officer. This change marks the end of an orderly transition that began in November 2020, when Maag became Executive Chairman. He will now step down from this role but will remain on the Board of Directors. Michael D. Goldberg, the lead independent Director, will return as independent Chair, a position he previously held from 2011 to 2019. CareDx focuses on precision medicine solutions for transplant patients.
CareDx, Inc. (CDNA) reported a record revenue of $75.6 million for Q3 2021, marking a 42% year-over-year increase. The company achieved an 86% growth in testing services volume, providing around 40,000 patient results. The launch of AlloSure Lung was announced, and a publication validating the AlloMap test was released. Despite the revenue growth, CareDx reported a net loss of $11.9 million for the quarter, compared to a $2.8 million loss in Q3 2020. The company anticipates full-year 2021 revenue between $290 million and $293 million.
CareDx announced the successful completion of a longitudinal study by OrganX involving over 1,000 kidney transplant patients. This study demonstrated that AlloSure Kidney can more accurately detect allograft rejection compared to traditional methods like eGFR and DSA testing. Key findings indicate that increased dd-cfDNA levels correlate with rejection activity. CEO Reg Seeto highlighted that this is the largest cohort of paired-biopsy results comparing AlloSure to standard care. The study solidifies AlloSure's position in the transplant monitoring market.
CareDx announces a collaboration with Eledon Pharmaceuticals to assess the efficacy of Eledon's investigational drug, AT-1501, in preventing organ rejection in renal transplants using AlloSure technology. Eledon recently secured approval from Health Canada for human trials of AT-1501, which is expected to commence in Q4 2021 with interim data releases anticipated in late 2022. This partnership aims to leverage CareDx's innovative solutions to enhance patient outcomes in transplantation.
CareDx, Inc. (Nasdaq: CDNA) is set to report its third quarter 2021 financial results on October 28, 2021, after market close. A conference call will follow at 1:30 p.m. PT/4:30 p.m. ET. Interested parties can join by calling 877-705-6003 or 201-493-6725, referencing Conference ID: 13724010. CareDx specializes in precision medicine solutions for transplant patients, providing a range of testing services and digital healthcare tools aimed at improving patient outcomes.
CareDx, Inc. (Nasdaq: CDNA) announced the commercial launch of AlloSure Lung on October 12, 2021, in conjunction with the CHEST 2021 Meeting. This non-invasive testing solution aims to improve the management of high-risk lung transplant patients, who face significant survival challenges and the risk of Chronic Lung Allograft Dysfunction (CLAD). AlloSure Lung has already received coverage from several private payers and is supported by three clinical validation studies involving 155 patients. The product aims to meet an unmet need and enhance precision care for transplant patients.
CareDx, Inc. (CDNA) announced a multicenter study validating its solutions AlloMap and AlloSure for kidney transplantation, as published in Kidney360. This study, encompassing data from 14 top transplant centers, demonstrates that AlloMap can effectively differentiate between organ rejection and immune quiescence. The combination of AlloSure and AlloMap provides a comprehensive assessment, achieving a combined AUC of 0.894. CEO Reg Seeto emphasized the extended application of multimodality solutions in kidney care, reflecting CareDx's commitment to innovate in transplant medicine.
CareDx, Inc. (Nasdaq: CDNA) announced that a false advertising lawsuit against Natera will proceed to trial on October 25, 2021. In a separate matter, CareDx plans to appeal a recent court ruling that deemed three of its patents regarding non-invasive organ transplant monitoring ineligible. The company firmly believes that Natera and Eurofins Viracor are infringing on its patents, which are exclusively licensed from Stanford University. CareDx remains committed to enhancing transplant patient outcomes through innovative solutions.
CareDx, Inc. (CDNA) has announced its participation in the upcoming ASHI conference, featuring eight scientific abstracts related to AlloSeq Tx17 and AlloSeq HCT. The conference will take place from September 27-30, 2021, in Orlando, FL, showcasing innovations in transplant care. CEO Reg Seeto expressed pride in advancing transplant solutions, emphasizing the transformative role of AlloSeq HCT. Additionally, CareDx will host a lunch symposium discussing future innovations across the transplant journey.
CareDx Appoints Art Torres to Board of Directors
CareDx, Inc. (Nasdaq: CDNA) announced the appointment of Art Torres to its Board of Directors. Torres, a former California state senator and advocate for organ transplantation, brings extensive expertise in regenerative medicine and health equity. He is currently involved with several organizations, including the California Institute for Regenerative Medicine and One Legacy. His addition to the board is seen as a move to strengthen CareDx's commitment to improving support for transplant patients across diverse communities.
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