REAL-WORLD IMPLEMENTATION OF THE CYTOSPONGE TEST IN SECONDARY CARE FOR PATIENTS AT RISK OF EARLY OESOPHAGEAL CANCER

ABSTRACT

Introduction The CytospongeTM test is a non-endoscopic method to collect cells from the oesophagus and test for biomarkers of early oesophageal cancer and its precancerous form, Barrett's oesophagus. The real-world implementation pilots of the Cytosponge has been accelerated in response to the COVID-19 pandemic. At the onset of the pandemic, when endoscopy services were paused, guidelines from the British Society of Gastroenterology were updated to recommend the use of alternatives including the Cytosponge. In December 2020, NICE published a Medtech Innovation Briefing for use of the Cytosponge test as a triage tool for endoscopy to identify people at risk of oesophageal cancer. Aims & methods Implementation pilots were launched within the NHS in England and Scotland, as well as the Innovate UK-funded research project, Project DELTA. The Cytosponge test was offered to two patient cohorts as an alternative to endoscopy (1) patients already diagnosed with Barrett's Oesophagus, and so in need of routine surveillance;and (2) patients referred from primary care with reflux symptoms. Samples were received, processed and analysed at the ISO 151892012 accredited laboratory at Cyted. Pathology reports were issued with TFF3, p53 and atypia biomarker results and clinical recommendations. Any reports positive for p53/atypia biomarkers were double reported. Here, we evaluate the real-world laboratory metrics for the Cytosponge test in secondary care. Results Between August 2020 and November 2021, Cytosponge tests were delivered to 5373 patients at 48 hospitals across England and Scotland. For 4842 diagnostic reports issued by mid-November, 2807 patients had Barrett's Oesophagus and 2034 reflux symptoms. For Barrett's surveillance, 2629 (93.7%) of patient samples had sufficient cellular material for analysis, including sampling the gastric cardia. Of these 324 (12.3%) exhibited cellular atypia (including uncertain significance), dysplasia, or aberrant p53 expression. These patients were recommended to have an endoscopy. Patients without evidence of atypia/dysplasia/p53 were recommended surveillance by Cytosponge or endoscopy after the recommended interval by clinical guidelines. In the symptomatic reflux cohort, 1854 (91.2%) patient samples had sufficient cellular material for analysis, including sampling the gastric cardia. Of these 185 (10.0%) exhibited intestinal metaplasia corroborated by TFF3 expression and a further 44 (2.4%) exhibited atypia/ dysplasia/p53. These patients were recommended to have an endoscopy. Otherwise, patients were recommended management according to symptoms. Discussion A high-quality centralised laboratory service has enabled accelerated real-world implementation of the Cytosponge in the secondary care setting. This has enabled triage and care of patients who have not been able to access endoscopy during the COVID-19 pandemic.