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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, a leader in precision medicine for transplant patients, showcased its innovations at the 2022 American Transplant Congress with over 50 presentations, including the first oral presentation of the OKRA study. The study involved data from over 50 centers, emphasizing the impact of CareDx’s multimodal KidneyCare solutions, including AlloSure and AlloMap. CEO Reg Seeto highlighted the potential of these technologies in improving patient outcomes. The congress runs from June 4-8 in Boston, Massachusetts.
CareDx Expands Transplant Portfolio in Europe
CareDx, Inc. (CDNA) announced the CE marking for its AlloSeq HCT chimerism testing kit and interpretation software, aimed at improving care for hematopoietic cell transplantation (HCT) patients in Europe. This innovative NGS-based test enhances sensitivity in monitoring engraftment compared to traditional methods. CEO Reg Seeto emphasized the company's commitment to delivering high-quality products. Dr. Jean Villard praised the AlloSeq HCT for its superior sensitivity, which could help predict early disease relapse.
CareDx, Inc. has announced the selection of Dr. Berta Sáez-Giménez for the ISHLT Innovation Challenge Award. Her research will utilize AlloSeq cfDNA to monitor treatment for chronic lung allograft dysfunction (CLAD), critical for improving outcomes in lung transplant patients. With a five-year survival rate around 53%, addressing CLAD is vital as it significantly affects mortality rates. CareDx aims to provide early warnings of organ injury through cfDNA testing, thereby enhancing transplant patient care.
CareDx, Inc. (NASDAQ: CDNA) announces updates in its ongoing patent battle with Natera. Natera has withdrawn a patent but has filed two variations against CareDx, which it believes are invalid and not infringed. This development follows a jury trial in March 2022 where CareDx was awarded $44.9 million for Natera's false advertising related to the Prospera test. CareDx maintains that its donor-derived cell-free DNA technology, AlloSure, is specifically designed for transplant patients.
CareDx, Inc. (CDNA) will present its AlloSeq portfolio at the EFI 2022 Conference from May 17-20 in Amsterdam. The AlloSeq solutions, crucial for HLA typing and post-transplant monitoring, highlight the company's leadership in transplant diagnostics. CEO Reg Seeto emphasized CareDx's unique focus on transplant solutions, which serve as vital tools for researchers and clinicians. The symposium on May 18 will discuss advancements in patient care related to transplantation, showcasing significant collaborations in the field.
CareDx, Inc. (CDNA) reported an 18% year-over-year revenue increase to $79.4 million for Q1 2022, driven by strong performance in testing services, which generated $66.4 million. The company showcased scientific leadership at the International Society of Heart and Lung Transplantation with over 25 presentations and secured $44.9 million in damages against Natera for false claims. Despite revenue growth, CareDx recorded a net loss of $19.6 million and a negative EBITDA of $5.6 million. The company reiterated its full-year 2022 revenue guidance of $330 million to $350 million.
CareDx, Inc. (CDNA) announced new data from the multi-center OKRA study confirming that AlloMap Kidney can predict allograft rejection, specifically antibody-mediated rejection (ABMR) and T cell-mediated rejection (TCMR). With a negative predictive value of 95%, this gene expression profiling can effectively distinguish rejection from quiescence in kidney transplant patients. CEO Reg Seeto noted that these findings advance their KidneyCare solutions. This data aligns with previous studies indicating AlloSure's effectiveness in monitoring renal transplant rejection.
CareDx, Inc. (CDNA) announced that Board member Dr. Hannah Valantine received the 2022 Lifetime Achievement Award from the International Society for Heart and Lung Transplantation during their annual meeting in Boston. Valantine's contributions include pioneering research in heart transplantation and innovations like AlloMap® Heart. Her leadership in the field and efforts to promote health equity in transplantation are highlighted. CEO Reg Seeto praised her for shaping public policy and improving patient care in transplant medicine.
CareDx, Inc. (Nasdaq: CDNA) has announced an expansion to its HeartCare multimodality portfolio, adding an AI prognostic tool for cardiac allograft vasculopathy (CAV) in partnership with OrganX. This development aims to enhance patient stratification by assessing the risk of CAV, a significant cause of heart transplant failure. By integrating this AI tool with existing products like AlloMap® and AlloSure®, CareDx intends to offer a more personalized approach to interventions for improving long-term heart transplant outcomes. The initiative follows positive outcomes from previous AI applications in the KidneyCare portfolio.
CareDx, Inc. (Nasdaq: CDNA) will report its first-quarter 2022 financial results after market close on May 5, 2022. Following the report, company management will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET. Interested participants can join by calling 877-300-8521 for domestic or 412-317-6026 for international access, using Conference ID: 10165254. CareDx specializes in precision medicine solutions for transplant patients, with offerings that include diagnostic testing and digital healthcare solutions.
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