CareDx (CDNA) Status update summary

Strategic vision, positioning, and market opportunity

• Focused on advancing AI-enabled relapse monitoring in AML and MDS post-cell therapy, aiming to lead in precision medicine for cell therapy and expanding into hematology and oncology.

• Transplant Plus portfolio targets high-severity, high-cost, and specialized cell therapy markets with unmet needs in relapse surveillance.

• Estimated total addressable market for AlloHeme is approximately $1 billion by 2030, driven by growth in allogeneic HCT and expanding eligible patient populations.

• Commercial launch of AlloHeme is planned for 2027, with payer coverage and revenue contribution expected by 2028.

• Integration with digital and patient solutions supports adoption in transplant centers and the broader cell therapy community.

AlloHeme product overview and differentiation

• AlloHeme is a blood-based, AI-enabled NGS test for early relapse detection after allogeneic HCT in AML and MDS patients.

• Utilizes next-generation sequencing and a proprietary AI algorithm to analyze micro changes in cell populations over time.

• Provides a simple positive/negative result, is non-invasive, and does not require prior knowledge of tumor mutations.

• Designed to be universally applicable and to fill a gap not addressed by current MRD or chimerism assays.

• Universally applicable across transplant variables and agnostic to donor type or pre-transplant MRD status.

Clinical evidence and ACROBAT trial results

• ACROBAT trial enrolled 285 patients across 11 centers, with 198 AML/MDS patients in the analytical cohort and two-year follow-up completed.

• AlloHeme demonstrated 85% sensitivity, 92% specificity, 95% NPV, 79% PPV, and an AUC of 0.89, with a median lead time of 41 days before clinical relapse.

• At 6 months post-transplant, positive AlloHeme results indicated a 12-fold higher relapse risk compared to negative results (p < 0.001).

• Outperformed current standard-of-care MRD and chimerism assays in sensitivity, NPV, and predictive lead time.

• Consistent performance across disease subgroups, donor types, conditioning regimens, and risk indices.