Highly Accurate Detection of Circulating Tumor DNA for Monitoring Minimal Residual Disease in Solid Tumors

Advances in cell-free DNA processing and error-suppressed next-generation sequencing have enabled detection of circulating tumor DNA (ctDNA) at low abundance for assessment of minimal residual disease (MRD). MRD testing requires high analytical specificity near the stochastic limit of rare molecule sampling amid a wild-type cell-free DNA background (ie, the “needle-in-a-haystack” analytical challenge). This study reports the analytical and clinical validation of Haystack MRD, a tumor-informed ctDNA MRD assay that tracks patient-specific somatic mutations with background noise suppression architecture to improve discrimination of the ctDNA signal from technical and biological interferences.