ASCO Annual Meeting 2026
Radiographic findings suspicious for malignancy can trigger prolonged, inconclusive diagnostic workups, and the performance of cfDNA methylation–based MCED assays in this diagnostic setting remains less well characterized than in asymptomatic screening populations. This study found that, at a prespecified 98.5% specificity threshold, the Harbinger assay showed comparable specificity and sensitivity in patients undergoing imaging-based malignancy workup and in a case-control study of newly diagnosed cancer cases versus asymptomatic controls, supporting further evaluation of MCED testing in diagnostically enriched, clinically relevant populations beyond asymptomatic screening.