Core Insights - CareDx (CDNA) announced clinical validation data for AlloHeme, a blood-based monitoring test aimed at predicting relapses in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) post-allogeneic hematopoietic cell transplant (HCT) [1][4] Group 1: AlloHeme Test Details - AlloHeme utilizes next-generation sequencing and artificial intelligence to enhance sensitivity in detecting early relapse signals compared to traditional methods [2][4] - The ACROBAT clinical study demonstrated that AlloHeme achieved 85% sensitivity and 92% specificity, detecting relapses a median of 41 days earlier than standard clinical diagnosis [9][12] - The assay's performance metrics indicate a 95% negative predictive value and a 79% positive predictive value, with an area under the curve of 0.89 [11] Group 2: Commercialization and Market Strategy - CareDx plans to roll out AlloHeme in the U.S. starting with CLIA readiness in 2026, followed by commercialization in 2027 and expected payer coverage by 2028 [3][9] - The company aims to expand its Transplant+ strategy into cell therapy and hematologic oncology, addressing unmet needs in AML and MDS monitoring [3][6] - The integrated offering will combine diagnostics, digital tools, and patient support solutions tailored for the cell therapy ecosystem [4][7] Group 3: Market Performance and Growth Potential - Following the announcement, CDNA shares increased by 2.8%, with a 65.6% rise over the past six months, significantly outperforming the industry and S&P 500 [5] - The clinical validation of AlloHeme is seen as a significant growth catalyst, enhancing CareDx's position in the cell therapy and hematologic oncology markets [6][7] - The cell therapy market is projected to reach $9.13 billion by 2026, with a compound annual growth rate (CAGR) of 22.9% through 2034, driven by advancements in technology and increasing disease prevalence [14][15]

PresentationI would now like to turn the conference over to Natasha Wagner. You may begin.Hello, and thank you for standing by. At this time, I would like to welcome everyone to the CareDx Investor Webinar Call. [Operator Instructions]Natasha Moshirian Wagner Hello, and thank you for joining us. I'm Natasha Wagner, VP of Corporate Communications at CareDx. Welcome to our investor webcast focused on AlloHeme, advancing AI-enabled relapse monitoring in AML and MDS post-cell therapy, positioning CareDx to lead ...

CareDx (NasdaqGM:CDNA) Update / briefing February 12, 2026 10:00 AM ET Company ParticipantsBrandon Couillard - Managing DirectorJeffrey Teuteberg - Chief Medical OfficerJohn Hanna - President and CEOMarica Grskovic - Chief Strategy OfficerNatasha Wagner - VP of Corporate CommunicationsRan Reshef - Professor of Medicine and Director of Translational ResearchConference Call ParticipantsAndrew Brackmann - Research Analyst of HealthcareBill Bonello - Senior Research AnalystTom DeBourcy - Senior Equity Research ...

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. ...

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 that pivotal clinical validation data from the ACROBAT study (NCT04635384) will be presented at the 2026 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT™ and CIBMTR®,. ...

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]

Financial Results - CareDx, Inc. announced preliminary unaudited financial results for the quarter and year ended December 31, 2025[4] - The financial results will be further detailed in the attached press release, which is incorporated by reference[5] Press Release - The press release detailing these results was issued on January 12, 2026[4] Company Information - The company is listed on The Nasdaq Stock Market under the trading symbol CDNA[2] - CareDx, Inc. is not classified as an emerging growth company[3]

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].