Company Description
CareDx, Inc. (Nasdaq: CDNA) is a precision medicine company in the medical laboratories industry focused on transplant medicine. According to company disclosures, CareDx describes itself as “The Transplant Company” and concentrates on the discovery, development, and commercialization of clinically differentiated, high‑value healthcare solutions for transplant patients and caregivers. The company highlights that it is a leading provider of genomics‑based information for transplant patients.
CareDx reports that its integrated solutions span the pre‑ and post‑transplant patient journey. These solutions include non‑invasive molecular testing services for heart, kidney, and lung transplants, laboratory products, digital health technologies, and patient solutions that support transplant care. The company states that it offers testing services, products, and digital healthcare solutions and that it generates the majority of its revenue from testing services, with additional revenue from products and patient and digital solutions.
Business focus and transplant solutions
CareDx positions its business around improving outcomes for transplant recipients and advancing organ health. Its commercially available testing services, as described in company information, include:
- AlloSure Kidney
- AlloMap Heart
- AlloSure Heart, a donor‑derived cell‑free DNA (dd‑cfDNA) solution for heart transplant patients
- AlloSure Lung, a dd‑cfDNA solution for lung transplant patients
The company also references HeartCare, which combines AlloMap and AlloSure Heart as a multimodal, non‑invasive approach to heart transplant surveillance. Published analyses from the Surveillance HeartCare Outcomes Registry (SHORE) cited by CareDx describe HeartCare’s molecular signals as providing prognostic information for heart transplant recipients and supporting risk stratification and personalized post‑transplant care.
In kidney transplantation, CareDx has announced HistoMap Kidney, described as a tissue‑based molecular test that characterizes rejection type and enhances the clinical utility of biopsy results by leveraging gene expression profiling. The company presents this as complementing histopathology with molecular information to provide more comprehensive diagnostic insights for kidney transplant patients.
Research, data, and clinical evidence
CareDx emphasizes clinical research as part of its business. The SHORE registry publications referenced by the company analyze large cohorts of heart transplant recipients and report that HeartCare’s molecular testing can identify risk for graft dysfunction and cardiovascular death, including in settings where biopsy findings appear normal. The company also highlights data showing that AlloSure Heart donor‑derived cell‑free DNA levels are associated with antibody‑mediated rejection and that changes in these levels may reflect response to treatment.
In kidney transplantation, CareDx has described studies evaluating donor‑derived cell‑free DNA and blood gene expression profiling in relation to graft function and rejection risk. Company communications indicate that these molecular tools are being studied as biomarkers that can support rejection screening and transplant management.
Products, laboratory offerings, and digital health
CareDx reports that it offers testing services, laboratory products, and patient and digital solutions along the transplant care continuum. The company’s disclosures describe:
- Non‑invasive molecular testing services for heart, kidney, and lung transplants, including dd‑cfDNA‑based assays and gene expression profiling.
- Lab products, including offerings such as HLA typing solutions referenced in company materials (for example, AlloSeq Tx11 and QTYPE analysis software, as described in a financial press release).
- Patient and digital solutions that support transplant centers and patients before and after transplant, which the company groups as patient and digital solutions revenue.
Across these categories, CareDx states that it focuses on genomics‑based and molecular diagnostics aimed at transplant rejection surveillance, risk assessment, and organ health monitoring.
Geographic presence and sector classification
CareDx identifies its headquarters as being in Brisbane, California, and some company press releases also reference operations in South San Francisco, California. The company is categorized in the medical laboratories industry within the broader health care and social assistance sector. CareDx’s common stock is listed on The Nasdaq Stock Market LLC under the ticker symbol CDNA, as indicated in its SEC filings.
Company information notes that CareDx generates the majority of its revenue from the United States and that testing services represent its largest revenue segment, with additional contributions from product revenue and patient and digital solutions revenue.
Corporate governance and regulatory disclosures
CareDx files periodic and current reports with the U.S. Securities and Exchange Commission (SEC). Recent Form 8‑K filings describe matters such as financial results, leadership changes, board appointments, and amendments to corporate governance documents. For example, the company has disclosed:
- Quarterly and preliminary annual financial results, including revenue breakdowns by testing services, product, and patient and digital solutions.
- Appointments of senior executives, such as a Chief Financial Officer and Chief Medical Officer, and the appointment of a new director to the board.
- An amendment and restatement of its bylaws to adopt a majority voting standard for the election of directors in uncontested elections, along with a director resignation policy tied to that standard.
- A proposed settlement of a shareholder derivative litigation, with preliminary court approval and a scheduled hearing date for consideration of final approval.
These disclosures illustrate how CareDx communicates material events, governance changes, and financial information to investors through SEC filings.
Position within transplant medicine
CareDx consistently describes itself in its press releases as a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The company emphasizes its focus on transplant‑specific diagnostics, genomics‑based information, and digital tools that support clinicians and patients along the transplant journey. By concentrating on transplant rejection surveillance, risk assessment, and organ health monitoring, CareDx positions its offerings within a specialized area of the medical laboratories and diagnostics sector.