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.
NICE Medtech Innovation Briefing
Read the NICE Medtech Innovation Briefing on capsule sponge technology.
AGA guidelines on screening for Barrett’s oesophagus
Read the American Gastroenterological Association Guidelines.
Incorporating the test
See how easy it is to incorporate EndoSign® into your practice.