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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. (CDNA) reported its Q3 2022 financial results, achieving revenue of $79.4 million, a 5% increase year-over-year. The number of patient test results grew by 15%, totaling 46,500. Despite a strong GAAP gross margin of 73%, the net loss widened to $16.9 million, with a loss per share of $0.32. Adjusted EBITDA showed a loss of $2.5 million, contrasting with a gain in Q3 2021. The company has adjusted its 2022 revenue guidance to $320-$325 million due to a shift in payer mix.
CareDx, the Transplant Company, recently announced its participation in the ASN Kidney Week 2022, where it will present data on AlloSure Kidney and digital health solutions. This event, taking place from November 3-6 in Orlando, Florida, is an opportunity for CareDx to showcase its commitment to improving transplant patient care. The company will feature nine abstracts highlighting AlloSure's role in post-transplant surveillance, supported by findings from the groundbreaking ADMIRAL study, which demonstrated AlloSure's predictive capabilities for long-term graft survival.
CareDx, Inc. announced a study published in the Clinical Journal of the American Society of Nephrology demonstrating the efficacy of AlloSure® dd-cfDNA as a biomarker for early detection of allograft rejection and BK virus infection in pediatric kidney transplant patients. This independent study involved 57 patients and showed significant results, including an AUC of 0.82 for acute rejection detection. The findings emphasize AlloSure's potential for improving transplant outcomes through timely interventions, supporting CareDx's position as a leader in transplant innovation.
CareDx, Inc. (NASDAQ: CDNA) has congratulated C-Path’s Transplant Therapeutics Consortium and the Paris Transplant Group for receiving European Medicine Agency's draft qualification for the iBox Scoring System, a significant step in kidney transplant trials. The iBox system evaluates graft failure risk by assessing renal function and immunologic responses. CEO Reg Seeto expressed pride in collaborating with these groups to further transplant innovation.
CareDx, Inc. (NASDAQ: CDNA) will report its financial results for Q3 2022 on November 3, 2022, after market close. A conference call will follow at 1:30 p.m. PT / 4:30 p.m. ET. Interested parties can listen by dialing 1-800-289-0438 for domestic calls or 1-323-794-2423 for international calls, using Conference ID: 2768596. The call will also be available via a live webcast on the company's investor relations website.
CareDx, Inc. (CDNA) announced a webinar in collaboration with the National Kidney Foundation and Honor the Gift Coalition to assist kidney transplant patients with Medicare enrollment related to the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020, effective January 1, 2023. The webinar, titled "2023 Medicare Immunosuppressant Coverage: What Patients Need to Know," will take place on October 27, 2022, covering patient eligibility and coverage options. CareDx's initiative reflects its commitment to improving patient access to essential immunosuppressive treatments.
CareDx, Inc. (NASDAQ: CDNA) has announced its sponsorship at the 48th annual meeting of the American Society for Histocompatibility and Immunogenetics (ASHI) in Las Vegas from October 24-28. The company will present its innovative NGS HLA typing kits and chimerism monitoring solutions. CEO Reg Seeto emphasized their commitment to driving transplantation innovation. Key presentations include the unique hybrid capture approach of AlloSeq Tx17 for better donor-recipient matching, enhancing long-term allograft survival rates. The event highlights CareDx's leadership in precision medicine for transplant patients.
CareDx, Inc. (NASDAQ: CDNA) will host a symposium at the Heart Failure Society of America Annual Scientific Meeting in Washington, D.C., from September 30 to October 3, 2022. The event will focus on innovations in post-cardiac transplant care, particularly the AI Heart Platform with AiCAV™ for assessing cardiac allograft vasculopathy risk. Key presentations will address heart transplant surveillance and predictive models for patient outcomes. CareDx, a leader in precision medicine for transplant patients, emphasizes early interventions to enhance graft and recipient health.
CareDx, Inc. (NASDAQ: CDNA) announced a new study confirming that AlloMap, the only gene-expression profiling blood test for heart transplant rejection, significantly reduces pain and adverse events compared to heart biopsy. Conducted at Baylor University Medical Center, the study involved 43 patients and demonstrated that AlloMap's home testing option minimizes infection risk. The test has been FDA cleared since 2005 and is used in over 90% of U.S. heart transplant centers. The results support CareDx's commitment to enhancing patient experiences in transplant care.
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