The assay provides physicians and patients with an individualized risk score from 0-10 and risk class (low, intermediate, high) to guide decision-making on surveillance frequency and therapies. The risk score is correlated with a probability of progression that is specified on the assay report. The report also includes an explanation of high risk abnormalities detected by the assay, where applicable. The information provided will be adjunctive to the ordering physicians’ normal workup for patients with Barrett’s esophagus. The 3-tier classifier identifies patients at very low risk of progressing to HGD/EAC within 5 years. This finding indicates that the frequency of endoscopic surveillance in this patient group can potentially be extended to 5 years. The classifier also identifies patients at very high risk of progression. Current clinical guidelines recommend endoscopic ablative therapy for confirmed HGD and there is growing evidence to support ablative therapy for confirmed LGD . The patients identified as high-risk by the classifier include patients with LGD, IND and ND confirmed by an expert GI pathologist. The independent validation of this risk prediction approach provides support to extend ablative therapy to BE patients with IND and ND by objectively identifying tissue changes indicative of future progression.
