Cernostics has completed two multi-institutional independent clinical validation studies on the TissueCypher™ Barrett’s Esophagus Assay. The first study demonstrated that the assay can predict future risk of development of HGD or EAC (n=366 patients). The second study demonstrated that the assay can detect a field effect associated with existing HGD and EAC that has been missed by standard endoscopy with random sampling (N=175). The clinical evidence indicates:
- TissueCypher™ identifies a high-risk subset of patients at 9.4x increased risk of progression to HGD or EAC within 5 years, and has stronger prognostic power than current clinical variables, including the pathologic diagnosis. 9
- The assay detects multiple molecular and cellular changes, including stromal changes, that are associated with neoplastic transformation. 9
- TissueCypher™ Assay identifies a subset of patients who have very low risk of progression within 5 years. 9
- Does the TissueCypher™ Barrett’s Esophagus Assay identify patients with Barrett’s Esophagus that may have existing/prevalent HGD/EAC that has not been detected by standard surveillance protocols? 10
- The detection of existing HGD/EAC can be confounded by the random nature of endoscopic sampling, which may miss dysplastic areas, and also by inter-observer variation, particularly in a background of chronic inflammation and reactive atypia that are common in BE. 10
- TissueCypher™ Assay identifies a subset of patients who have low pathologic diagnoses of non-dysplastic (ND), indefinite for dysplasia (IND) or low grade dysplasia (LGD), but have HGD or EAC elsewhere in their esophagus that was missed by random endoscopic sampling. 10
- TissueCypher™ detection of multiple molecular and cellular abnormalities in the expanded neoplastic field may overcome the limitations of random sampling and subjective diagnoses, and has the potential to enable earlier detection of HGD and EAC in BE. 10