Clinical evidence

The capsule sponge technology of EndoSign® is embedded in the NHS. It has been evaluated over 10 years of clinical trials and real world implementation.

Take a look at some of the supporting evidence.

  • Biomarker analysis produces a 10-fold increase in detection of Barrett’s oesophagus compared with standard of care.
  • Capsule sponge testing has comparable accuracy to other screening tests and may be a simple and inexpensive approach for identifying patients with reflux symptoms who warrant endoscopy to diagnose Barrett’s oesophagus.
    Read the BEST2 study
  • Capsule sponge tests like EndoSign® provide a cost-effective screening alternative to usual care for patients with reflux symptoms.
  • Capsule sponge testing and laboratory biomarkers can be used to prioritise endoscopic surveillance of patients with Barrett’s oesophagus.
  • A pilot study demonstrated the potential cost savings of capsule sponge tests like EndoSign® in monitoring patients with Barrett’s oesophagus.

Studies show the accuracy of EndoSign® 

Biomarkers used to analyse cells collected with capsule sponge tests like EndoSign® have been shown to have a high level of accuracy in detecting Barrett's oesophagus, with a specificity of 92% and sensitivity of 90%, as demonstrated in the BEST3 study.

Capsule sponge testing has additionally been found to be effective in detecting oesophageal cancer, defined as high grade dysplasia or intramucosal adenocarcinoma, with a specificity of 91% and sensitivity of 94% (for patients with segments C ≥3 cm and repeat testing for inadequate samples) when patients are safety netted by clinical risk factors.‍

Specificity for detecting Barrett's oesophagus, dysplasia, or cancer was found to be 94%, with a positive predictive value of 59% in BEST3. The negative predictive value for detecting Barrett's oesophagus was found to be 99% in both BEST1 and BEST2 studies.