Core Viewpoint - CareDx is focusing on advancing AI-enabled relapse monitoring for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) post-cell therapy, positioning itself as a leader in precision medicine for cell therapy [1]. Group 1: Company Overview - CareDx is conducting an investor webinar to discuss its initiatives and advancements in precision medicine [1]. - The company aims to enhance its competitive position and explore potential growth opportunities within the industry [2]. Group 2: Future Outlook - CareDx's future business plans include the development of testing services and digital solutions aimed at increasing revenue and commercial success [2]. - The company is engaged in clinical trial collaborations and registry studies to support its growth and market opportunities [2].

CareDx Investor Webinar Call Summary Company Overview - **Company**: CareDx - **Focus**: Development of AlloHeme, an AI-enabled solution for relapse monitoring in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) post-cell therapy, aiming to lead in precision medicine for cell therapy [2][9] Key Points Industry Context - **Market Growth**: Solid organ transplantation is a growing market, driven by federal policies and technological advances, with CareDx capturing over 70% of the serviced market [9] - **Cell Therapy Market**: The cell therapy market is expanding rapidly, with allogeneic hematopoietic cell transplants (HCT) and CAR T-cell therapies being primary focuses. The market is expected to grow at a 9% CAGR for HCT and 30% for CAR T-cell therapies from 2024 to 2028 [14][15] AlloHeme Development - **Target Population**: AlloHeme is designed for high-risk patients with hematologic malignancies, particularly those undergoing allogeneic HCT and CAR T-cell therapies [10][12] - **Monitoring Solution**: AlloHeme utilizes next-generation sequencing to analyze micro changes in cell populations from peripheral blood samples, providing a non-invasive method for relapse prediction [17][18] - **Clinical Validation**: The ACROBAT trial demonstrated AlloHeme's high sensitivity (85%) and specificity (92%) for detecting relapse, with a median lead time of 41 days before clinical relapse [41][45] Market Opportunity - **Total Addressable Market (TAM)**: Estimated at approximately $1 billion, driven by an increasing patient population eligible for HCT, with 70% for AML and 45% for MDS [57] - **Commercialization Timeline**: CareDx plans to launch AlloHeme in early 2027, following the publication of the ACROBAT study and completion of CLIA readiness activities [60] Competitive Landscape - **Current Monitoring Tools**: Existing tools for relapse monitoring, such as chimerism testing and MRD approaches, have limitations in sensitivity and require invasive procedures like bone marrow biopsies. AlloHeme aims to fill this gap with a more sensitive, non-invasive alternative [23][24][49] Future Directions - **Standardization Goal**: CareDx aims for AlloHeme to become a standardized tool for monitoring relapse in post-allogeneic HCT patients, addressing the variability in current monitoring practices [63][64] - **Clinical Utility Evidence**: Future studies will focus on demonstrating the clinical utility of AlloHeme in improving health outcomes through earlier detection and intervention [64][66] Additional Insights - **Patient Journey**: The patient journey post-transplant involves intensive monitoring for relapse, with a significant gap in current practices due to the infrequency of sensitive assessments like bone marrow biopsies [21][22] - **Regulatory Considerations**: CareDx anticipates that coverage decisions for AlloHeme will begin in 2028, which will be crucial for market adoption [60] This summary encapsulates the key points discussed during the CareDx Investor Webinar Call, highlighting the company's strategic focus on AlloHeme and its potential impact on the cell therapy market.

BRISBANE, Calif.--(BUSINESS WIRE)--CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, highvalue healthcare solutions for transplant patients and caregivers, today announced pivotal clinical validation results of AlloHeme™, a non-invasive, nextgeneration sequencing (NGS)–based, and artificial intelligence (AI)-powered monitoring test designed to predict relapse in. ...

Core Insights - CareDx, Inc. is a leading precision medicine company focused on healthcare solutions for transplant patients and caregivers [1] Group 1 - The company announced pivotal clinical validation data from the ACROBAT study (NCT04635384) [1] - This data will be presented at the 2026 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT™ and CIBMTR® [1]

Company Overview - CareDx provides diagnostic solutions for transplant patients and caregivers, including donor-derived cell-free DNA tests, gene expression tests (AlloMap Heart), and transplant patient management software [5] - The company generates revenue through direct sales and third-party distributors, offering both testing services and software products to healthcare providers and transplant centers [5] Financial Performance - As of January 31, 2026, CareDx's stock price was $20.55, with a market capitalization of $1.06 billion [4] - The company reported a total revenue of $358 million and a net income of $70.45 million for the trailing twelve months (TTM) [4] - For the fourth quarter of FY 2025, CareDx announced preliminary revenue of $108 million, representing a 25% year-over-year increase, which beat analyst expectations [7] Recent Transactions - John Walter Hanna Jr., President and CEO of CareDx, sold 19,480 shares on January 21 and 22, 2026, for a total value of approximately $412,200 [1] - This sale was part of a Rule 10b5-1 plan, indicating that it was planned in advance, and he had sold another 10,156 shares a week earlier for $214,292 [6] - The shares sold represented 3.16% of Hanna Jr.'s direct ownership, leaving him with 597,405 shares valued at approximately $12.56 million post-transaction [2][8] Market Outlook - CareDx expects strong growth in its testing services throughout 2026, particularly with its AlloSure Kidney solution and AlloMap Heart [7] - Following a lackluster performance in 2025, CareDx's stock rose approximately 9% in January 2026, indicating potential for recovery [8]

Company Overview - CareDx is a healthcare diagnostics company that specializes in advanced molecular and digital solutions for transplant patient care, focusing on organ and stem cell transplant monitoring [1] - The company generates revenue through direct sales and third-party distribution of proprietary diagnostic tests, software platforms, and related services [2] Recent Transactions - John Hanna, President and CEO of CareDx, sold 19,480 shares in multiple open-market transactions on January 21 and 22, 2026, with an aggregate transaction value of approximately $412,200 [7] - This sale was part of a Rule 10b5-1 trading plan, which allows insiders to buy and sell shares at predetermined times to avoid the appearance of insider trading [8] Insider Ownership - The transaction reduced direct holdings by 3.16%, leaving John Hanna with 597,405 directly held shares, which still represents a substantial ownership position post-sale [5] - The sale of 19,480 shares was the largest among two recent sell-only trades by John Hanna, surpassing the prior transaction of 10,156 shares [6] Financial Performance - CareDx's stock is down 9.36% over the last year and 75.4% since January 22, 2021, but its financial results and future outlook appear promising [9] - The company announced preliminary fourth-quarter revenue of approximately $108 million, an increase of 25% year over year, and full-year revenue of approximately $380 million, an increase of 14% year over year [9] - CareDx repurchased 5.8 million shares for $88 million at an average price of $15.16 per share, indicating strong cash-flow management [9] Strategic Initiatives - CareDx announced a strategic collaboration with 10x Genomics to establish a research initiative called ImmuneScape, which will study the biology of transplant organ rejection and support clinical diagnostic development [10]

Group 1 - CareDx, Inc. (CDNA) reported preliminary fourth quarter revenue of approximately $108 million, an increase of 25% year-over-year [1] - Testing services revenue for the fourth quarter was approximately $78 million, reflecting a 23% increase [1] - Testing services volume reached approximately 53,000, marking a 17% increase [1] Group 2 - Preliminary revenue for 2025 was approximately $380 million, an increase of 14% year-over-year [2] - Testing services revenue for 2025 was approximately $274 million, an increase of 10% [2] - Testing services volume for 2025 was approximately 200,000, an increase of 14% [2]

Core Viewpoint - CareDx, Inc. reported preliminary, unaudited financial results for the fourth quarter and full year 2025, highlighting significant revenue growth in the transplant healthcare sector [1]. Financial Performance - The company achieved revenue of approximately $108 million in the fourth quarter of 2025, representing a 25% increase year-over-year [1].

Core Viewpoint - CareDx, Inc. has announced a strategic collaboration with 10x Genomics to establish ImmuneScape, a multiomics research initiative aimed at enhancing healthcare solutions for transplant patients and caregivers [1] Group 1: Company Overview - CareDx, Inc. is a leading precision medicine company focused on the discovery, development, and commercialization of high-value healthcare solutions for transplant patients and caregivers [1] - 10x Genomics is recognized as a leader in single cell and spatial biology [1] Group 2: Strategic Collaboration - The collaboration between CareDx and 10x Genomics is aimed at establishing ImmuneScape, which is designed to elucidate complex biological systems [1]

Core Viewpoint - The analysis of CareDx, Inc. (CDNA) presents a contrarian perspective, rating the stock as a "Sell" despite prevailing Hold or Buy ratings from other analysts [1]. Group 1: Investment Philosophy - The company emphasizes the importance of patient investing and the accumulation of high-quality assets over time [1]. - It advocates for a balanced investment strategy that includes both steady growth and high-risk, high-reward opportunities [1]. - The company values integrity in investing, focusing on businesses that contribute positively to society [1]. Group 2: Analyst Background - The analyst has over 25 years of investing experience and a PhD from Brunel University, indicating a strong academic background [1]. - The analyst is self-taught in investing, highlighting a commitment to continuous learning and growth through diverse reading [1].