UK-based gastrointestinal health firm Cyted has gained 510(k) clearance from the FDA for its non-endoscopic diagnostic test EndoSign.
The EndoSign system picks up cells from the whole length of the digestive tract – the patient swallows a dissolvable vitamin pill containing a sponge, which is attached to a piece of surgical thread. The pill dissolves in the stomach and collects cells while it is removed from the patient’s digestive system using the thread.
The cell-containing sponge is then sent off to the laboratory for diagnostic tests that can detect oesophageal pre-cancer and other conditions such as eosinophilic esophagitis.
The system is already being used in the UK as part of a heartburn health check which assesses patients with persistent heartburn for their risk of developing cancer. The company, which was spun out of Cambridge University, received a £1m ($1.25m) grant in December 2023 from Innovate UK, the government’s business grant arm, to further develop the test.
Earlier this month, Cyted signed a commercial agreement with Devyser Genomic Laboratories in the US, bringing the heartburn health check to the US, assisted by the FDA clearance.
Traditionally, oesophageal diseases are diagnosed using endoscopy-based tests, where a flexible tube with a camera is used to examine the digestive tract. Cyted aims to curb the need for endoscopy examinations which can be invasive for patients, expensive, and time-consuming for medical professionals.
In the announcement accompanying the clearance, Cyted CEO Marcel Gehrung said: “This clearance opens up significant opportunities for Cyted across new geographies and health systems and confirms our device is safe and effective for use in the US.
"Combined with novel biomarkers, Cyted’s potential to transform the way patients with chronic reflux are identified and monitored is significant and this clearance is a major step for our expansion.”
In November, Lucid Diagnostics launched its EsoGuard Esophageal DNA test (EsoGuard 2.0) to detect oesophagal precancer. The assay will extract DNA from oesophageal cells that are gathered using the EsoCheckcell collection device.
