The Cytosponge test is set to change the diagnosis of Barrett’s oesophagus, the pre-cancerous condition predisposing individuals to oesophageal cancer, in the US following an update to clinical guidelines from the American College of Gastroenterology (ACG) supporting its use in screening.

Published in American Journal of Gastroenterology (AJG), the revised guidelines synthesise current best practices in the management of Barrett’s esophagus with several key changes since its last iteration. Critically, the ACG now recognises and supports the Cytosponge test as an alternative to endoscopy for screening of Barrett’s esophagus in those with risk factors including chronic reflux symptoms.

Clinicians across the US recognise the importance of screening and early diagnosis for oesophageal cancer. Survival rates following diagnosis remain dismal, at less than 20% after five years. Barrett’s oesophagus affects at least 5.6% of the US population   and is the greatest risk factor for oesophageal cancer, increasing the risk by 10-55 times that of the general population. Thus, it is critical to detect Barrett’s oesophagus earlier and faster to improve patient outcomes and save lives. 

The ACG declare that “the greatest experience to date and largest available evidence base has been with the Cytosponge device”. Their recommendation to apply the Cytosponge test for the screening of Barrett’s oesophagus could transform outcomes for thousands of patients and clinicians.

Revising the guidelines marks a milestone for clinicians and health providers across the US. The ACG recognises the substantial progress that has been made in developing Cytosponge as a minimally invasive, cost-effective test for Barrett’s oesophagus.

The Cytosponge is praised for the breadth of its clinical evidence base, both in the United Kingdom (UK) and the US, including safety, cost-effectiveness, accuracy and patient perceptions when compared with endoscopy. Screening patients with chronic reflux with the Cytosponge test has been shown to detect 10-times as many cases of Barrett’s oesophagus compared with standard of care, which is only being offered endoscopy if seen as necessary by their healthcare provider. The recommendation by the ACG for a “nonendoscopic capsule sponge device combined with a biomarker” further emphasises that the Cytosponge is the only commercially available technology with significant evidence base and commercial scale in recent years.

Marcel Gehrung, CEO and co-founder at Cyted, said: “It’s excellent to see the Cytosponge test being recognised as a safe and effective alternative to endoscopy for the screening of Barrett’s oesophagus by the ACG. This will have a huge impact in the US, where millions of people are affected by chronic reflux symptoms, the primary symptom of Barrett’s esophagus, a well-defined precursor to esophageal cancer. 

At Cyted, we are working relentlessly with our partners to accelerate the roll-out of the Cytosponge test in the UK, EU, US and beyond to save lives by spotting the signs of cancer earlier and faster, allowing clinicians to stop it in its tracks. Underpinning our work at Cyted are pivotal results, and we are looking forward to collaborating with clinicians, partners and patients in the US following this momentous decision by the ACG.”

Rebecca Fitzgerald, professor for cancer prevention and co-founder at Cyted, said: “The latest clinical guidelines from the ACG offers great news for patients across the US. Cyted are well positioned to continue this momentum to drive positive change and improve early diagnosis of esophageal cancer, and we are committed to supporting the rollout of the Cytosponge.”

The updated ACG clinical guidelines follow the expansion of Cytosponge across NHS England and NHS Scotland to deliver the test for patients living with chronic reflux symptoms and Barrett’s esophagus. To date, many thousands of Cytosponge tests have been delivered across the UK.