CareDx (CDNA) Status update summary

Strategic vision and market opportunity

• Focus on advancing AI-enabled relapse monitoring in AML and MDS post-cell therapy, aiming to lead in precision medicine for cell therapy.

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

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

• Commercial launch of AlloHeme planned for early 2027, with payer coverage decisions anticipated in 2028.

AlloHeme product overview and differentiation

• AlloHeme is a blood-based, AI-enabled monitoring solution for early cancer 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.

• Positioned as the first ultra-sensitive, non-invasive, blood-based surveillance solution for AML and MDS post-HCT.

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 high predictive power for relapse, with hazard ratios up to 11.9 and area under the ROC curve of 0.89.

• Sensitivity was 85%, specificity 92%, negative predictive value 95%, and positive predictive value 79%, 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 assays, which have lower sensitivity and no predictive lead time.