Clinical Context
A 62-year-old male with a history of chronic gastroesophageal reflux disease and known Barrett’s esophagus undergoes routine surveillance upper endoscopy with biopsies. The endoscopist submits formalin-fixed esophageal biopsy specimens to the pathology laboratory. The pathologist performs routine histopathology and requests the TissueCypher® Barrett’s Esophagus Assay to provide objective risk stratification for progression to high-grade dysplasia or esophageal adenocarcinoma. The laboratory processes the proprietary TissueCypher assay (reportable under CPT 0108U), integrates the assay result with the histologic interpretation, and issues a combined pathology report to the treating gastroenterologist. Typical sites of service include outpatient hospitals, ambulatory surgery centers, and commercial clinical reference laboratories. The typical clinical workflow: endoscopy with biopsy → histology processing and review → reflex or requested molecular assay (0108U) by the reference lab → molecular result returned to pathologist and ordering clinician to inform surveillance interval or management discussions.
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|
43239 | Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single or multiple | Endoscopic procedure that yields the biopsy specimen tested by the TissueCypher assay |
88305 | Level IV surgical pathology, gross and microscopic examination | Histopathologic evaluation of esophageal biopsy specimens that accompanies ordering of the molecular assay
88367 | Immunohistochemistry, per single antigen-antibody stain; initial single stain | Ancillary stain sometimes performed on biopsy tissue as part of diagnostic workup alongside molecular testing
0003U | Molecular pathology test (example PLA code) | Other proprietary laboratory analyses that may be ordered in conjunction with or instead of 0108U depending on clinical context
81002 | Urinalysis, by dip stick or tablet reagent for bilirubin, etc.; without microscopy | Data not available in the input.
0108U | TissueCypher® Barrett’s Esophagus Assay | The specific PLA code reported for the proprietary assay performed by Cernostics Lab to stratify risk of progression in Barrett’s esophagus