Clinical Summary

• Treatment plans for patients with BE are based upon risk-stratification (risk of progression). TissueCypher was shown to be the most important predictor of progression.
• TissueCypher has an additive impact on existing clinicopathologic factors; e.g. a High Risk TissueCypher test result in a male BE patient, with 3 cm long NDBE, changes risk of IPP from 4.47x to 22.54x (1.02 + 3.45 + 18.07).
• Identify high-risk BE patients who are likely to progress and increase endoscopic surveillance or consider endoscopic eradication therapy.
• Identify low-risk BE patients who are unlikely to progress and extend surveillance intervals or more optimally administer treatment.
• Use adjunctively to inform key clinical management decisions, allowing upstaging/downstaging based on individual patient risk.
   

Predicting patients that are likely to progress to esophageal cancer is influenced by several factors, but intervention (esophageal eradication) and endoscopic surveillance recommendations are determined almost exclusively based on clinicopathologic factors. This pooled analysis was performed to confirm the utility of the TissueCypher test in predicting BE progression compared to clinicopathologic factors alone.

Assess the ability of TissueCypher to predict progression to high-grade dysplasia (HGD) or EAC in patients with BE. Compare the performance of progression risk models using only clinicopathologic variables: age, segment length, sex, hiatal hernia, and pathology then add the TissueCypher risk score to determine if it improves the predictive power of the model.

Pooled patient-level data from 5 peer-reviewed published studies predicting both incident progression to HGD or EAC, and the combination of incident (progression in > 12 months) and prevalent progression (progression in <12 months). Perform conditional logistical regression analysis to compare the risk prediction performance of clinicopathologic factors alone and in combination with TissueCypher.

• Across all analyses, TissueCypher was the strongest and most significant predictor of progression to HGD or EAC.
  
• Predictive performance of clinicopathologic factors was significantly improved by the inclusion of the TissueCypher risk classes.
• In the NDBE patient cohort, a TissueCypher high risk score predicted an 18-fold increased risk of progression vs. TissueCypher low risk score.
• TissueCypher identified 52% of the NDBE progressors, all of whom were missed by the standard of care.