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CareDx, Inc. (Nasdaq: CDNA) is a precision medicine company in the medical laboratories industry that focuses on transplant patients and caregivers. The company describes itself as “The Transplant Company” and emphasizes genomics‑based information, non‑invasive molecular testing, and digital health technologies for heart, kidney, and lung transplantation. This news page brings together company announcements and disclosures that illustrate how CareDx develops and commercializes transplant‑focused diagnostics and solutions.
Readers can expect news related to financial results, where CareDx reports revenue across testing services, product revenue, and patient and digital solutions revenue. The company issues press releases on quarterly and preliminary annual performance, highlighting trends in testing services volume and segment‑level revenue. These updates provide context on how its transplant‑focused offerings are used in clinical practice.
CareDx also publishes clinical and scientific updates, including data from the Surveillance HeartCare Outcomes Registry (SHORE) and other transplant studies. These releases describe how HeartCare, AlloSure Heart, and related molecular tests are evaluated as biomarkers for rejection risk, graft dysfunction, and treatment response in heart and kidney transplantation. Product‑focused news, such as the introduction of HistoMap Kidney and other molecular assays, further illustrates the company’s emphasis on transplant diagnostics.
Additional news items cover corporate and governance developments, such as leadership appointments, board changes, equity inducement grants under Nasdaq Listing Rule 5635(c)(4), and participation in investor conferences. Together, these updates offer investors, clinicians, and other stakeholders a consolidated view of CareDx’s activities in precision transplant medicine. For ongoing insight into CDNA, this page serves as a central source for company press releases and related disclosures.
CareDx announced that a District Court has overturned a jury verdict in a patent infringement case, invalidating all patent claims asserted against the company by competitor Natera. This reversal eliminates the previous $96 million verdict against CareDx.
The Court ruled the patents invalid because they failed to describe the claimed invention in sufficient detail. CareDx believes this decision represents the correct legal outcome and benefits transplant patients.
CareDx developed AlloSure®, the industry's first donor-derived cell-free DNA assay for identifying organ rejection in transplant patients, which was commercially introduced in 2017 for kidney transplant patients and later validated for heart and lung transplants.
If Natera appeals, CareDx plans to continue defending its technology. Additionally, the patent underlying the $96 million verdict is subject to a pending ex parte reexamination by the USPTO, which issued a non-final Office action on February 14, 2025, rejecting the claims CareDx was found to have infringed.
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.
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