Early cancer diagnostic test, the Cytosponge, receives ACG backing for the screening of Barrett’s Esophagus

• The Cytosponge test is recommended as an effective alternative to endoscopy for screening of Barrett’s esophagus by the American College of Gastroenterology (ACG) in its latest clinical guidelines.
• Application of the Cytosponge test in the screening of Barrett’s esophagus will transform outcomes for patients and clinicians.
• Cyted is partnering across healthcare systems to accelerate the roll-out of the Cytosponge test globally and save tens of thousands of lives through the earlier and faster detection of cancer.

CAMBRIDGE, UK, 11 April 2022:

The Cytosponge test is set to revolutionise the diagnosis of Barrett’s esophagus, the pre-cancerous condition predisposing individuals to esophageal cancer, in the United States (US) following an update to clinical guidelines from the American College of Gastroenterology (ACG) supporting its use in screening^[1].

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 esophageal cancer. Survival rates following diagnosis remain dismal, at less than 20% after five years^[2]. Barrett’s esophagus affects at least 5.6% of the US population^[3] and is the greatest risk factor for oesophageal cancer, increasing the risk by 10-55 times that of the general population^[4]. Thus, it is critical to detect Barrett’s esophagus 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”[5]. Their recommendation to apply the Cytosponge test for the screening of Barrett’s esophagus will transform outcomes for thousands of patients and clinicians.

Revising the guidelines marks a huge 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 esophagus.

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 esophagus compared with standard of care, which is only being offered endoscopy if seen as necessary by their healthcare provider^[6]. The recommendation by the ACG for a “nonendoscopic capsule sponge device combined with a biomarker”[7] 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 esophagus 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.

^[1] American Journal of Gastroenterology. Diagnosis and Management of Barrett's Esophagus: An Updated ACG Guideline. April 2022. Available at: https://journals.lww.com/ajg/Fulltext/2022/04000/Diagnosis_and_Management_of_Barrett_s_Esophagus_.17.aspx [Last accessed: April 2022]

^[2] Cancer Research UK oesophageal cancer statistics, 2013-2017. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/oesophageal-cancer [Last accessed: April 2022]

^[3] Dis Esophagus. The Prevalence of Barrett’s Esophagus in the US: Estimates from a Simulation Model Confirmed by SEER Data. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2896446/ [Last accessed: April 2022]

^[4] British Medical Journal. Cancer incidence and mortality risks in a large US Barrett’s esophagus cohort. Available at: https://gut.bmj.com/content/67/3/418 [Last accessed: April 2022]

[5] American Journal of Gastroenterology. Diagnosis and Management of Barrett's Esophagus: An Updated ACG Guideline. April 2022. p.566 Available at: https://journals.lww.com/ajg/Fulltext/2022/04000/Diagnosis_and_Management_of_Barrett_s_Esophagus_.17.aspx [Last accessed: April 2022]

^[6] The Lancet. Cytosponge-trefoil factor 3 versus usual care to identify Barrett's esophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial. August 2020. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31099-0/fulltext [Last accessed: April 2022]

[7] American Journal of Gastroenterology. Diagnosis and Management of Barrett's Esophagus: An Updated ACG Guideline. April 2022. p.566 Available at: https://journals.lww.com/ajg/Fulltext/2022/04000/Diagnosis_and_Management_of_Barrett_s_Esophagus_.17.aspx [Last accessed: April 2022]