CareDx (NASDAQ:CDNA) used an investor webcast to outline its “Transplant Plus” expansion into cell therapy and to highlight new data supporting AlloHeme, a blood-based test designed to predict relapse following allogeneic hematopoietic cell transplantation (HCT) in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
Positioning AlloHeme within CareDx’s broader strategy
President and CEO John Hanna said CareDx’s long-standing footprint in solid organ transplantation provides a foundation for its next growth area. He cited the company’s scale across the transplant ecosystem, including IVD kits supporting more than 200,000 HLA typing and matching tests annually, software used by 70% of U.S. transplant centers, more than 150,000 prescriptions filled each year for immunosuppression therapy, and more than 1 million molecular assays performed to monitor for organ rejection.
Why CareDx is targeting AML and MDS post-transplant monitoring
CareDx’s initial cell therapy focus includes both allogeneic HCT and CAR T-cell therapies, but the webcast centered on relapse monitoring after allogeneic HCT in AML and MDS. Hanna argued these patients follow a longitudinal care pathway similar to solid organ transplant, with structured surveillance and frequent follow-up, especially in the first year.
He noted CareDx estimates about 20,000 patients will undergo allogeneic HCT and CAR T therapy in 2025, and said adoption of cell therapies is growing faster than underlying disease incidence. As examples, he cited AML diagnoses growing around 2% annually while allogeneic HCT used in AML is forecast to grow at a 9% CAGR from 2024 through 2028; CAR-T use was described as expected to grow 30% over the same period.
Hanna also emphasized that, unlike many minimal residual disease (MRD) tools that track tumor-derived signals, AlloHeme is intended to be “tumor-naive” and universally applicable without requiring predefined mutations or tumor signatures. CareDx positioned AlloHeme as complementary to other MRD approaches, particularly in diseases where molecular relapse tools are already established or emerging.
Clinical need and AlloHeme’s approach
Chief Medical Officer Dr. Jeffrey Teuteberg reviewed the post-transplant monitoring burden and relapse risk. He cited Center for International Blood and Marrow Transplant Research figures showing a two-year post-transplant relapse rate of 30%–35% in AML and 35%–45% in MDS, and said relapse accounts for nearly 50% of mortality beyond 100 days post-transplant.
Teuteberg described a key gap in current surveillance: routine clinic visits and blood work are frequent but not sensitive for early relapse, while bone marrow biopsy is more informative but performed infrequently due to invasiveness and logistical burden. He said an ideal surveillance tool must be:
- Sensitive, beyond the limitations of widely used chimerism testing and heterogeneous MRD methods in AML and MDS;
- Non-invasive, avoiding reliance on bone marrow biopsies for high sensitivity;
- Universal, not dependent on known mutations or bespoke tumor targets.
According to Hanna and Teuteberg, AlloHeme uses next-generation sequencing from a peripheral blood draw to measure micro-changes in cell populations over time. Results are analyzed with a proprietary AI-derived algorithm incorporating longitudinal data from whole blood and cell lineages, producing a positive/negative output intended to be clinically straightforward.
ACROBAT trial: two-year performance data presented at Tandem Meetings
Guest speaker Dr. Ran Reshef of Columbia University, a co-principal investigator on the ACROBAT study, summarized two-year results he presented at the 2026 Tandem Meetings. He described ACROBAT as a prospective observational study run at 11 centers, enrolling 285 patients between 2021 and 2023, designed to develop and assess the AI-based AlloHeme algorithm. Testing in the protocol was biweekly for three months, monthly for the next three months, and quarterly from month nine through month 24.
Reshef said the AML and MDS cohort included 227 enrolled subjects, with 198 included in the analytical cohort for the conference presentation. The analysis observed 40 relapses, and 118 patients completed two years of follow-up; he also noted non-relapse mortality occurred in the cohort.
Reshef highlighted several performance metrics from the two-year analysis for AML and MDS relapse monitoring:
- Landmark analysis hazard ratios for relapse of 5.9 to 11.9 for patients testing positive at or before two-, three-, and six-month milestones; relapse-free survival hazard ratios of 4.1 to 6.2.
- Overall assay performance: area under the ROC curve (AUC) of 0.89, sensitivity of 85%, and specificity of 92%.
- Negative predictive value of 95%.
- Median lead time of 41 days before clinical relapse.
He discussed six false negatives and nine false positives. Reshef said four of the false negatives reflected missed last tests before relapse, and noted that sites had a median of 11 tests per patient versus 14 recommended in the protocol. For the nine false positives, he said three patients received interventions (such as donor lymphocyte infusion or maintenance therapy) despite investigators being blinded to AlloHeme results, and one patient relapsed after the 24-month study cutoff.
Reshef also described a comparison to real-world monitoring practices reported by participating sites. He said standard-of-care chimerism testing showed about 60% sensitivity with a median lead time of zero days, and modeling an STR-PCR-like 1% cutoff reduced sensitivity to 53%. He further said that when combining real-world tools such as chimerism testing, bone marrow-based flow cytometry, and other molecular methods, sensitivity remained low and often detected relapse only once relapse was clinically apparent.
Commercialization timeline, TAM estimate, and Q&A themes
Teuteberg said CareDx estimates AlloHeme’s total addressable market at approximately $1 billion, based on assumptions including HCT eligibility rates of roughly 70% for AML and 45% for MDS, a testing cadence aligned to the ACROBAT schedule, and pricing assumptions informed by analogous transplant and molecular monitoring models. He emphasized the TAM estimate represents an opportunity framework rather than current clinical practice.
CareDx outlined a multi-year path to market:
- 2026: publish ACROBAT results and complete CLIA readiness and analytical verification.
- Early 2027: anticipated commercial launch and submission for Medicare and private payer coverage.
- 2028: estimated timing for coverage decisions to begin, with expected revenue contribution as coverage expands.
In the Q&A, management said CareDx’s vision is a centralized CLIA lab service that could standardize relapse monitoring post-allogeneic HCT. The company said further adoption would be supported by clinical utility evidence as clinicians begin using AlloHeme to detect relapse earlier and intervene. Asked about testing frequency and reimbursement, the company said it views the 14-test protocol as appropriate and said it expects to pursue established Medicare and private payer assessment pathways, coding, and pricing processes. On assay mechanics, Chief Strategy Officer Marica Grskovic said AlloHeme uses hundreds of SNPs and an algorithm that relies on longitudinal results, producing a patient-specific signal while remaining tumor-naive.
About CareDx (NASDAQ:CDNA)
CareDx, Inc (NASDAQ: CDNA) is a precision diagnostics company focused on the care of transplant patients. The firm develops and commercializes non‐invasive tests designed to detect organ transplant rejection and infection risk, helping physicians make informed management decisions throughout the post‐transplant journey.
The company’s core product portfolio includes AlloMap®, a gene expression profiling test for heart transplant recipients, and AlloSure®, a donor‐derived cell‐free DNA assay used primarily in kidney transplant monitoring.
