Gastrointestinal molecular diagnostics company, Cyted Health, has enrolled the first patient in its ‘DETECT-ME’ clinical validation study. The study will evaluate the company’s advanced molecular assays using esophageal cells to detect Barrett’s Esophagus (BE) and esophageal adenocarcinoma (EAC).
EAC is a significant public health concern due to its rising incidence, late-stage diagnosis, and high mortality. According to SEER (Surveillance, Epidemiology, and End Results program) data, over 22,000 new cases and more than 16,000 deaths from esophageal cancer occurred in the US in 2024, with a five-year survival rate of just 22 per cent.
The vast majority of EAC patients – approximately 90 per cent – have never been diagnosed with its only known precursor, Barrett’s Esophagus, underscoring the need for improved early detection strategies.
Endoscopy with biopsy remains the standard of care for diagnosing BE and EAC, but additional tools are needed to help identify at-risk individuals sooner.
Cyted Health’s approach combines minimally invasive cell collection with advanced diagnostics. It delivers a clinically proven detection method, backed by real-world evidence, that significantly enhances early identification of Barrett’s Esophagus and EAC thereby enabling timely therapeutic intervention.
The study will enrol 18 individuals and will be co-led by principal investigators Dr. Nick Shaheen, professor of medicine at the University of North Carolina School of Medicine, and Dr. Sachin Wani, professor of medicine and gastroenterology at the University of Colorado Anschutz Medical Center.
“Early and accurate detection of Barrett’s Esophagus is essential,” said Shaheen.
“The DETECT-ME study will generate essential data on the performance of this minimally invasive diagnostic approach. By refining our detection methods, we can improve early identification of at-risk patients and support more effective clinical decision-making.”
“This study represents an important advancement in evaluating minimally invasive diagnostics for Barrett’s Esophagus and esophageal cancer,” said Wani.
“By generating robust clinical data, we can better understand how these tools complement existing diagnostic pathways and enhance early detection efforts.”
Cyted Health has already demonstrated success in the UK, where widespread adoption of its technology has led to earlier-stage cancer detection and improved patient outcomes. The company is now actively progressing its US evidence plan to support the broader clinical adoption of its platform leveraging the EndoSign cell collection device.
Betsy Hanna, president and general manager of Cyted Health, said: “We are committed to ensuring every at-risk patient in the US has access to the right diagnostic pathway. By expanding minimally invasive screening options, we can identify more BE cases early, allowing patients to receive appropriate clinical care before progression to EAC.”
