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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 (NASDAQ: CDNA) announced findings published in Transplant International showing that AlloSeq cfDNA's performance in detecting allograft rejection matches their established AlloSure test. The multicenter prospective study, involving 580 kidney transplant patients from three European transplant centers, demonstrated AlloSeq cfDNA's high accuracy in detecting kidney allograft rejection.
The study revealed a significant difference between rejection and non-rejection cases (p<0.0001) with an AUC of 0.758. AlloSeq cfDNA's performance was consistent with AlloSure Kidney across various clinical scenarios, including post-transplant timepoints, allograft stability, and rejection subcategories. This technology aims to provide early detection of rejection, allowing physicians to intervene before irreversible organ damage occurs.
AlloSeq cfDNA is CE-IVD marked and available in the EU and UK markets, where approximately 18,000 kidney transplants are performed annually. The product is not available in the US.
CareDx (CDNA) presented new data from the ACROBAT study for its AlloHeme™ test at the 2025 Tandem Meetings. The interim analysis, involving 229 patients from 11 U.S. transplant centers, demonstrated AlloHeme's effectiveness in monitoring relapse after allogeneic stem cell transplantation in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).
The study showed impressive performance metrics, including a hazard ratio of 40.5 (p<0.001) for relapse detection and a median lead time to relapse of 36 days. AlloHeme, an NGS-based test, proved more sensitive than current standard care methods for monitoring engraftment and relapse post-allogeneic hemopoietic stem cell transplantation.
CareDx (Nasdaq: CDNA), a company focused on transplant healthcare solutions, has announced it will release its fourth quarter and full year 2024 financial results after market close on Wednesday, February 26, 2025. The company will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on the same day. Interested parties can access the call via phone using 1-800-267-6316 (domestic) or 1-203-518-9783 (international) with Conference ID: CareDx. A webcast will also be available through the Events & Presentations section of CareDx's Investor Relations website.
CareDx (CDNA) reported preliminary Q4 2024 results with expected revenue between $85-86 million, representing a 30% year-over-year increase. Testing services revenue is anticipated at $62.5-63.5 million, up 35% YoY, with testing volume reaching 45,500, a 14% increase.
For full-year 2024, revenue is expected to be $332-333 million, with Digital Solutions and Products each contributing $11.4 million. The company projects a GAAP loss of $58-60 million, but expects adjusted EBITDA gain of $25-26 million. Cash position strengthened to approximately $261 million, up $26 million YoY.
Looking ahead, CareDx provides 2025 revenue guidance of $370 million and maintains its 2027 targets of $500 million in revenue with 20% adjusted EBITDA. The company completed its sales and marketing team expansion with approximately 30 new professionals.
CareDx (CDNA), a precision medicine company specializing in transplant healthcare solutions, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The company's management team is scheduled to deliver a presentation on Tuesday, January 14, 2025, at 4:30 PM PT (7:30 PM ET).
Interested parties can access the webcast through the Events & Presentations section of CareDx's Investor Relations website at investors.caredx.com. The company, which focuses on developing and commercializing high-value healthcare solutions for transplant patients and caregivers, continues to maintain its position as a leading force in transplant medicine.
TC BioPharm (NASDAQ: TCBP), a clinical-stage biotechnology company developing allogeneic gamma-delta T cell therapies, announced a partnership with CareDx (NASDAQ: CDNA) to support the ACHIEVE clinical trial. This phase II, open-label study aims to evaluate the efficacy of TCB008, an allogeneic gamma delta T cell therapy for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).
CareDx will use its AlloCell solution for pharmacokinetic analysis to monitor the expansion and persistence of TCB008 in patients. The data collected will help understand the duration and effect of TCB008 in reconstituting the immune system of AML patients. Alison Bracchi, EVP of Clinical Operations at TC BioPharm, highlighted the partnership as a significant milestone in developing TCB008. Marica Grskovic, PhD, CareDx Chief Strategy Officer, emphasized the collaboration's role in advancing allogeneic cell therapy for AML patients.
CareDx (CDNA) announces a partnership with TC BioPharm to provide pharmacokinetic analysis using its AlloCell™ solution in the ACHIEVE clinical trial. The phase II trial evaluates TCB008, an allogeneic gamma-delta T-cell therapy for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). AlloCell, which has been used in ten previous cell therapy trials, will monitor the expansion and persistence of TCB008 in trial patients. This partnership aligns with CareDx's strategic expansion into hematology oncology, specifically focusing on pharmacokinetic and monitoring assays for cell therapy patients.
CareDx (Nasdaq: CDNA), a precision medicine company specializing in transplant healthcare solutions, has announced its participation in three upcoming investor conferences. The company will present at the Jefferies London Healthcare Conference on November 19 at 4:00 AM EST, the Stephens Investment Conference in Nashville on November 21 at 9:00 AM EST, and the Piper Sandler Healthcare Conference in New York on December 4 at 10:10 AM EST. Interested parties can access the webcasts through CareDx's Investor Relations website at investors.caredx.com.
CareDx reported strong Q3 2024 results with total revenue of $82.9 million, up 23% year-over-year. Testing Services volume increased 16% to 44,600 tests. While reporting a GAAP net loss of $7.4 million, the company achieved non-GAAP net income of $8.0 million and positive adjusted EBITDA of $6.9 million. Cash flow from operations was $12.5 million, with $241 million in cash and no debt. The company raised its 2024 revenue guidance to $327-331 million and adjusted EBITDA guidance to $18-22 million. CMS reaffirmed Medicare coverage for AlloSure® and AlloMap® testing, and surveillance testing mix in kidney showed improvement.
CareDx and Dovetail Genomics have announced a strategic partnership to advance HLA genotyping for organ and stem cell transplant matching. The collaboration combines CareDx's AlloSeq Tx 17, the first HLA typing solution covering 17 loci, with Dovetail's Hi-C LinkPrep technology to achieve high-resolution genotyping and haplotyping without family studies. The partnership includes an Early Access Program for HLA labs to evaluate innovative donor-recipient matching methods. The combined technology's performance will be presented at the 50th annual ASHI meeting.
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