Welcome to our dedicated page for Caredx news (Ticker: CDNA), a resource for investors and traders seeking the latest updates and insights on Caredx stock.
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 reported strong Q1 2025 financial results with total revenue reaching $84.7 million, an 18% year-over-year increase. The company achieved its seventh consecutive quarter of growth in testing services, with volume rising to 47,100 tests.
Key highlights include:
- Testing services revenue: $61.9 million (+15% YoY)
- Patient and Digital Solutions revenue: $12.0 million (+24% YoY)
- Product revenue: $10.8 million (+26% YoY)
While reporting a GAAP net loss of $10.4 million, the company showed significant improvement with non-GAAP net income of $5.4 million and positive adjusted EBITDA of $4.6 million. CareDx maintains a strong financial position with $231 million in cash and no debt. The company reaffirmed its 2025 revenue guidance of $365-375 million and introduced expanded indications for AlloSure Testing Services.
CareDx presented new data on AlloSure Lung at the 2025 International Society for Heart and Lung Transplantation Meeting in Boston. The findings showcase significant advancements in transplant monitoring technology.
Key highlights from the research include:
- AlloSure Lung successfully detected acute cellular rejection onset and treatment response through surveillance monitoring
- The technology was used to monitor Tacrolimus inhalation powder safety in lung transplant patients with renal issues
- The ALAMO study revealed AlloSure Lung may predict Chronic Lung Allograft Dysfunction (CLAD)
- Higher AlloSure dd-cfDNA levels early post-transplant were linked to restrictive allograft syndrome (RAS)
The research, presented across 8 abstracts including 2 oral presentations, also demonstrated that the AlloHome remote monitoring system improved patient care efficiency and reduced staff workload. These findings suggest potential improvements in long-term outcomes for lung transplant patients.
CareDx (NASDAQ: CDNA) announced the presentation of 60 abstracts, including 19 oral presentations, at the 2025 International Society for Heart and Lung Transplantation Meeting. The presentations showcase data from 92 transplant centers demonstrating the clinical importance of CareDx's transplant testing solutions.
Key findings from the SHORE study revealed that HeartCare is prognostic of long-term graft outcomes independent of biopsy results. The study showed that dual-positive HeartCare results predict worse outcomes even with normal biopsy results, while early surveillance with HeartCare achieved similar 5-year survival rates with significantly fewer biopsies compared to traditional methods.
The company will host two sponsored symposia featuring experts from leading transplant centers discussing HeartCare and AlloSure Lung applications in clinical decision-making. Research demonstrated HeartCare's effectiveness in monitoring rejection across diverse patient populations, including women, Black Americans, and patients with chronic kidney disease.
CareDx (CDNA) has announced the granting of inducement stock awards to Jennifer Foley, their newly appointed Chief Product Officer, on April 7, 2025. The compensation package includes:
- 36,231 restricted stock units (RSUs) under the 2016 Inducement Equity Incentive Plan
- Performance-based stock units (PSUs) with 15,528 shares at target levels and up to 31,056 shares at maximum performance levels under the 2019 Inducement Equity Incentive Plan
The RSUs will vest over four years, with 25% vesting after the first year and 1/16th vesting quarterly thereafter. The PSUs have a two-year performance period plus one year of time-based vesting, with 50% eligible to vest on February 1, 2026, and the remaining 50% vesting in equal installments on February 1, 2027, and 2028, subject to performance goals and continued employment.
CareDx (Nasdaq: CDNA), a company specializing in transplant healthcare solutions, has announced it will release its first quarter 2025 financial results after market close on Wednesday, April 30, 2025. The company will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss the results.
Interested participants can join the call by dialing 1-800-445-7795 (domestic) or 1-785-424-1699 (international) with Conference ID: CareDx. A webcast will be available in the Events & Presentations section of CareDx's Investor Relations website.
CareDx (CDNA) has announced two major expansions for its AlloSure® testing services. The first expansion extends AlloSure Heart testing to pediatric heart transplant patients under 15 years old, including infants. Studies show the test can detect rejection types ACR and AMR in pediatric patients, with one study demonstrating an 81% reduction in surveillance biopsies.
The second expansion validates AlloSure Kidney for simultaneous pancreas-kidney (SPK) transplant patients. Both expansions have received approval from the New York State Clinical Laboratory Evaluation Program. The kidney test helps differentiate patients at increased rejection risk from those with low rejection likelihood.
These expansions address significant market opportunities, considering that over 4,500 heart transplants were performed in the U.S. in 2024 (10% under age 18) and more than 700 patients received SPK transplants in the same year.
CareDx (CDNA) reported strong financial results for Q4 and full year 2024. The company achieved full-year revenue of $333.8 million, up 19% year-over-year, with testing services revenue growing 19% to $249.4 million.
Q4 2024 highlights include revenue of $86.6 million (+32% YoY), testing services revenue of $63.8 million (+37% YoY), and testing volume of 45,500 (+14% YoY). The company reported GAAP net income of $87.7 million for Q4 and $52.5 million for the full year.
CareDx ended 2024 with $261 million in cash and no debt. The Board authorized a $50 million share repurchase program. For 2025, the company projects revenue between $365-375 million and adjusted EBITDA of $29-33 million.
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.