CareDx, Inc.（凯达公司）- Global Leader in Transplant Diagnostics and Precision Medicine

📢 Key Milestones (2025-2026):
   Full year 2025 revenue reached $379.8 million (+14% YoY), with Q4 revenue of $107.5 million (+25% YoY). Testing volume grew to approximately 202,000 tests annually. The company launched AlloSure Heart pediatric indication and AlloSure Plus, established the ImmuneScape™ multi-omics discovery platform with 10x Genomics, and introduced VANTx™, an AI-powered clinical data analytics platform. In March 2026, Keith Kennedy assumed the role of COO and CFO. The company provided 2026 revenue guidance of $420 million to $444 million.

Company Overview (Updated April 2026)

CareDx, Inc. is a leading precision medicine company dedicated to the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. Headquartered in Brisbane, California, the company was founded in December 1998 (originally as XDx, Inc.) and rebranded as CareDx in March 2014. As "The Transplant Company™", CareDx has established itself as the global leader in transplant diagnostics, serving transplant centers worldwide with non-invasive molecular testing solutions.

Corporate History

- 1998: Founded in California with focus on applying genomics and bioengineering to transplant medicine

- 2005: AlloMap Heart received FDA approval as the first non-invasive blood test to assess acute cellular rejection risk in heart transplant patients

- 2012: Listed on Nasdaq (NASDAQ: CDNA)

- 2014: Rebranded as CareDx, Inc., initiating diversified transplant diagnostic strategy

- 2016-2019: Launched AlloSure Kidney (dd-cfDNA testing for kidney transplant rejection monitoring), expanded to heart and lung transplantation

- 2024: Full year revenue $333.7 million; reported net income of $52.5 million (including $96.3 million litigation settlement gain)

- 2025: Revenue reached $379.8 million (+14%); launched AlloSure Heart pediatric indication and AlloSure Plus; established ImmuneScape™ platform with 10x Genomics; announced pivotal AlloHeme validation data (ACROBAT study)

- March 2026: Appointed Keith Kennedy as Chief Operating Officer and Chief Financial Officer; launched VANTx™ AI platform

Core Business Segments

Testing Services

AlloSure® dd-cfDNA Testing:

- AlloSure Kidney: Donor-derived cell-free DNA (dd-cfDNA) test for monitoring kidney transplant rejection, covering both acute rejection and antibody-mediated rejection

- AlloSure Heart: dd-cfDNA testing for heart transplant patients, with pediatric indication launched in 2025

- AlloSure Lung: dd-cfDNA monitoring solution for lung transplantation

- AlloSure Plus: Expanded indication testing service

2025 Testing Services revenue: $274.5 million (+10% YoY), with approximately 202,000 tests delivered (+14% volume growth). Average revenue per test approximately $1,470 in Q4 2025.

Gene Expression Testing (AlloMap)

- AlloMap Heart: Gene expression profiling test for heart transplant recipients, FDA-cleared for non-invasive rejection risk assessment without biopsy

- Clinical Validation: The SHORE (Surveillance Heart Care Outcomes Registry) study demonstrated that combined molecular testing provides independent prognostic information beyond biopsy alone, with abnormal results associated with approximately 3-fold increased 30-day risk of graft dysfunction and cardiovascular death

Patient & Digital Solutions

- Ottr™: Comprehensive transplant patient management software supporting clinical decision-making

- AlloCare™: Mobile application for transplant patients providing education resources and self-management tools

- XynQAPI™ / ZynQAPI™: Quality tracking software updated to include IOTA (Increasing Organ Transplant Access) calculations for real-time performance monitoring

- MedActionPlan: Patient discharge planning and medication therapy management tool

- Epic Aura Integration: Seven transplant centers live as of Q4 2025, with approximately twenty implementations underway

2025 Patient & Digital Solutions revenue: $56.9 million (+31% YoY)

Laboratory Products

- AlloSeq™ Portfolio: Next-generation sequencing (NGS) HLA typing solutions (AlloSeq Tx, AlloSeq cfDNA, AlloSeq HCT for chimerism testing)

- Olerup SSP®: Sequence-specific primer HLA typing technology

- QTYPE®: High-resolution HLA typing solution, now IVDR certified in Europe

- AlloSeq TX11 & SCOR 7: Launched in Q4 2025, designed to improve workflow efficiency and regulatory alignment

2025 Product revenue: $48.4 million (+19% YoY)

Cell Therapy & Hematologic Malignancies (AlloHeme™)

- AlloHeme™: AI-powered, NGS-based blood test for relapse monitoring following allogeneic hematopoietic cell transplant in AML (acute myeloid leUKemia) and MDS (myelodysplastic syndromes)

- ACROBAT Trial Results (2025): Demonstrated median 41-day earlier relapse detection versus clinical practice, with 85% sensitivity, 92% specificity, 95% negative predictive value, and 79% positive predictive value (AUC 0.89)

- Commercial Timeline: Expected launch in early 2027, with CLIA readiness in 2026 and anticipated payer coverage in 2028

- Strategic Partnership: Collaboration with TC BioPharm for the ACHIEVE clinical trial

Financial Performance (FY 2025)

Full Year Results

- Total Revenue: $379.8 million (+14% YoY)

- Testing Services Revenue: $274.5 million (+10%)

- Testing Volume: Approximately 202,000 tests (+14% YoY)

- Patient & Digital Solutions: $56.9 million (+31%)

- Product Revenue: $48.4 million (+19%)

- Non-GAAP Gross Margin: 69.3%

- Adjusted EBITDA: $31.7 million (compared to $27.8 million in 2024)

- Cash Collections: $405.6 million (+32% YoY)

- Days Sales Outstanding (DSO): Improved from 71 days to 41 days

- Cash & Marketable Securities: $201.4 million as of December 31, 2025

- Share Repurchases: $88 million for 5.8 million shares at average price of $15.16

Q4 2025 Highlights

- Revenue: $107.5 million (+25% YoY)

- Testing Services Revenue: $78.0 million (+23%)

- Testing Volume: Approximately 54,000 tests (+17% YoY)

- Average Revenue per Test: ~$1,470 (including ~$5 million prior period revenue)

- Cash Collections: $115.8 million (+37% YoY)

2026 Financial Guidance

- Revenue: $420 million to $444 million (11%-17% growth)

- Testing Services Revenue: $306 million to $326 million

- Testing Volume: 220,000 to 228,000 tests

- Average Revenue per Test: Approximately $1,400-$1,410 (blended), reflecting Medicare LCD impact and PLA code reimbursement changes

- Non-GAAP Gross Margin: 69%-71%

- Adjusted EBITDA: $30 million to $45 million

- Medicare LCD Impact: Guidance includes estimated $7.5 million revenue reduction (half-year effect) from proposed Local Coverage Determination (LCD) implementation

Strategic Initiatives & Innovation Pipeline

ImmuneScape™ Multi-Omics Platform

Established in 2025 through strategic collaboration with 10x Genomics, combining single-cell sequencing and spatial transcriptomics technologies to identify novel signal mechanisms and biomarkers in transplantation, supporting next-generation precision diagnostics development.

VANTx™ AI Platform (February 2026 Launch)

AI-powered, cloud-based clinical data and analytics platform built on Databricks and Llama 3 model. VANTx transforms complex transplant data into research and real-world evidence insights, enabling secure cohort analyses across longitudinal patient timelines using de-identified molecular tests and clinical trial data. The platform will incorporate validated predictive models from KOAR, SHORE, ALAMO, and MAPLE studies to support research in kidney, heart, lung, and liver transplantation.

iBox Kidney Transplant Prediction

Licensing agreement with Cibiltech SAS (France) to commercialize iBox software, an FDA Breakthrough Device-designated predictive analytics tool for kidney allograft loss following transplantation.

HistoMap™ Kidney

Tissue-based molecular test launched November 2025, utilizing gene expression profiling to objectively characterize rejection type and enhance biopsy clinical utility. Available early 2026 through clinical study.

Corporate Information

Company Name: CareDx, Inc.

Founded: December 22, 1998

Headquarters: Brisbane, California, USA

Stock Ticker: CDNA (NASDAQ)

Employees: Approximately 500+

CEO: John W. Hanna, Jr. (since 2019)

COO & CFO: Keith Kennedy (appointed March 2026)

Chief Data & AI Officer: Dr. Jing Huang (appointed October 2024)

Market Position & Competition

Market Leadership

CareDx holds a dominant position in the dd-cfDNA transplant monitoring market, serving hundreds of transplant centers across the United States and internationally. The company maintains deep integration with Epic electronic health records and other major EHR systems.

Key Competitors

- Natera (Signatera): ctDNA testing in the transplant and oncology space

- Eurofins Viracor: Transplant diagnostic laboratory services

- Traditional Biopsy: Tissue biopsy remains the gold standard for rejection diagnosis, though dd-cfDNA testing is increasingly adopted as adjunctive standard of care

Medicare Coverage & Regulatory Dynamics

CMS Local Coverage Determination (LCD)

The proposed Medicare LCD, expected to be finalized mid-2026, is anticipated to negatively impact revenue by approximately $15 million annually if implemented as drafted. CareDx has incorporated a conservative $7.5 million half-year impact into its 2026 guidance. The company continues to engage with CMS and the transplant community to demonstrate the clinical value of molecular surveillance testing, supported by evidence from the SHORE registry and other clinical studies.

IOTA (Increasing Organ Transplant Access)

The proposed CMS IOTA rule for Year 2 is expected to drive increased kidney transplant volume, including expanded use of medically complex organs, potentially creating tailwinds for CareDx's testing services as surveillance protocols expand.

Contact Information

Headquarters: Brisbane, California, USA

Website: www.caredx.com

Investor Relations: investors.caredx.com

Media Contact: Natasha Moshirian Wagner (nwagner@CareDx.com)

Investor Contact: Caroline Corner (investor@CareDx.com)

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