CareDx Reports Positive Data for AlloHeme in AML and MDS Post HCT

CareDx CDNA recently announced clinical validation data supporting AlloHeme, its next-generation, blood-based monitoring test designed to predict relapses in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) following allogeneic hematopoietic cell transplant (HCT).

AlloHeme leverages next-generation sequencing and artificial intelligence to detect early relapse signals with greater sensitivity than traditional bone marrow and marker-specific testing approaches, positioning the assay as a universal surveillance solution for post-transplant AML and MDS patients. The findings were generated from the ACROBAT clinical study and presented at the 2026 Tandem Meetings, with additional discussion as part of the company’s investor webcast outlining commercialization plans.

CDNA plans to expand into cell therapy and hematologic oncology through its Transplant+ strategy, targeting unmet needs in AML and MDS monitoring. AlloHeme’s U.S. rollout is expected to begin with CLIA readiness in 2026, commercialization in 2027 and anticipated payer coverage by 2028.

Per management, post-transplant relapses continue to be the primary driver of mortality among AML and MDS patients following allogeneic hematopoietic cell transplantation. AlloHeme advances the company’s Transplant+ strategy by extending beyond solid organ transplant into cell therapy with a highly sensitive, blood-based assay designed to detect relapses earlier. Results from the ACROBAT study underscore the assay’s clinical utility and the company plans to commercialize the test as part of an integrated offering that combines diagnostics, digital tools and patient support solutions tailored for the cell therapy ecosystem.

Likely Trend of CDNA Stock Following the News

Shares of CDNA have gained 2.8% since the announcement on Thursday. Over the past six months, shares of the company have surged 65.6% compared with the industry’s 8.6% growth and the S&P 500’s 8% rise.

In the long run, the clinical validation of AlloHeme marks a meaningful growth catalyst for CDNA, strengthening its expansion beyond solid organ transplantation into the cell therapy and hematologic oncology markets. Strong performance metrics from the ACROBAT study, including high sensitivity, specificity and earlier relapse detection, position the assay as a differentiated monitoring solution addressing an unmet need in AML and MDS post-transplant surveillance.

The planned phased U.S. launch with CLIA readiness in 2026, commercialization in 2027 and expected payer coverage by 2028 creates a clear pathway for incremental revenue contribution while expanding the company’s precision medicine portfolio. The Transplant+ strategy broadens CareDx’s long-term addressable market, enhances its leadership in transplant diagnostics and supports the development of a broader ecosystem of molecular monitoring tools across cell therapy, hematology and oncology.

CDNA currently has a market capitalization of $1.01 billion.

More on the AlloHeme Validation

The ACROBAT trial was a prospective, multi-center observational study spanning 11 U.S. transplant centers. The 24-month dataset included 198 evaluable patients and 40 relapse events. In this cohort, AlloHeme demonstrated robust diagnostic accuracy, with 85% sensitivity and 92% specificity, translating into a 95% negative predictive value, a 79% positive predictive value and an area under the curve of 0.89.

The assay detected relapse a median of 41 days earlier than standard clinical diagnosis, highlighting its potential to enable earlier clinical intervention. At six months post-transplant, patients with a positive AlloHeme result had a 12-fold higher risk of relapse versus those with negative results. Study investigators also reported that AlloHeme demonstrated improved sensitivity and earlier detection relative to conventional monitoring approaches, including bone marrow-based assessments and multi-parameter flow cytometry MRD testing.

Dr. Ran Reshef, Professor of Medicine at Columbia University and Director of Translational Research for its Blood and Marrow Transplantation Program, described the findings as a meaningful advancement in relapse monitoring for AML and MDS patients. AlloHeme provides a streamlined, clinically practical approach to identify high-risk patients earlier in the post-transplant setting, which could enable more timely, preemptive treatment strategies aimed at reducing relapse rates and improving overall survival outcomes.

Industry Prospects Favoring the Market

Going by the data provided by Precedence Research, the cell therapy market is valued at $9.13 billion in 2026 and is expected to witness a CAGR of 22.9% through 2034.

Factors such as the advancements in cell and gene therapy technologies, growing adoption of bone marrow transplantation and stem cell therapies, increasing prevalence of cancer and chronic diseases, integration of AI and machine learning in gene therapy, and improving regulatory pathways and clinical trial activity are enhancing the market expansions.

Other News

In January, CareDx entered a collaboration with 10x Genomics to launch ImmuneScape, a multiomics research initiative to advance understanding of transplant rejection biology and therapeutic response. Leveraging 10x’s Xenium spatial and Chromium Flex single-cell platforms, the program will generate high-resolution immune maps to better characterize AMR and MVI and inform future diagnostic development. The initiative builds on CareDx’s recent launch of HistoMap Kidney and supports its broader strategy to enhance precision transplant medicine, enabling improved treatment selection, prognosis and alignment with emerging therapies such as anti-CD38 agents.

CareDx, Inc. Price

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CDNA’s Zacks Rank & Key Picks

Currently, CDNA has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Intuitive Surgical ISRG, GE HealthCare Technologies GEHC and AtriCure ATRC.

Intuitive Surgical, sporting a Zacks Rank #1 (Strong Buy) at present, reported fourth-quarter 2025 adjusted earnings per share (EPS) of $2.53, beating the Zacks Consensus Estimate by 12.4%. Revenues of $2.87 billion surpassed the Zacks Consensus Estimate by 4.7%. You can see the complete list of today’s Zacks #1 Rank stocks here.

ISRG has an estimated long-term earnings growth rate of 15.7% compared with the industry’s 13% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 13.2%.

GE HealthCare Technologies, currently carrying a Zacks Rank #2 (Buy), reported fourth-quarter 2025 adjusted EPS of $1.44, which surpassed the Zacks Consensus Estimate by 0.7%. Revenues of $5.7 billion beat the Zacks Consensus Estimate by 1.9%.

GEHC has an estimated long-term earnings growth rate of 9.1% compared with the industry’s 13% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 7.5%.

AtriCure, currently carrying a Zacks Rank #2, reported a third-quarter 2025 adjusted loss per share of 1 cent, narrower than the Zacks Consensus Estimate by 90.9%. Revenues of $134.3 million beat the Zacks Consensus Estimate by 2.1%.

ATRC has an estimated earnings growth rate of 109.1% for 2026 compared with the industry’s 15.8% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 67.1%.

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