Cyted Health, a leading gastrointestinal molecular diagnostics company, today announces the enrollment of the first patients in the DETECT-ME clinical validation study (NCT06803927). The study evaluates Cyted Health’s advanced molecular assays using esophageal cells collected with the FDA 510(k)-cleared EndoSign® cell collection device to detect Barrett’s Esophagus (BE) and esophageal adenocarcinoma (EAC).

The DETECT-ME study, co-led by principial investigators Dr. Nick Shaheen (Professor of Medicine & Senior Associate Dean for Clinical Research at the University of North Carolina School of Medicine) and Dr. Sachin Wani (Professor of Medicine, Gastroenterology, University of Colorado Anschutz Medical Center, Executive Director, Rady Esophageal & Gastric Center of Excellence), will enroll individuals across 18 sites in the US. This study builds upon Cyted Health’s extensive portfolio of peer-reviewed research and real-world clinical experience in the UK, where its technology has been widely adopted.

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%. The vast majority of EAC patients—approximately 90%—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.

“Early and accurate detection of Barrett’s Esophagus is essential,” said Dr. Nick 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,” added Dr. Sachin 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.

Ms. Betsy Hanna, President & General Manager of Cyted Health, added, “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.”

Cyted Health is honoured to announce that we have been awarded the Best Provider of Diagnostic Services at the HSJ Partnership Awards 2025. This prestigious award recognises our commitment to enhancing early cancer detection across the UK through our innovative, non-endoscopic diagnostic solution.​

In response to the COVID-19 pandemic’s impact on endoscopy services in Scotland, Cyted partnered with NHS Scotland to introduce the capsule sponge test, a minimally invasive device designed to detect Barrett’s oesophagus and early signs of oesophageal cancer. This initiative aimed to alleviate pressure on endoscopy services by serving as a triaging and surveillance tool, ensuring that high-risk patients receive timely and accurate diagnoses.​

Impact

The implementation of the capsule sponge test has led to significant improvements in patient care and system efficiency:​

• Detection Impact: The proportion of endoscopies revealing important findings increased from under 10% to over 50%, facilitating early intervention for high-risk patients.​
• Reduced Waiting Times: Waiting times for endoscopies decreased from nine months to five months, enhancing patient experience and reducing anxiety.​
• Improved Resource Allocation: There was a 77% reduction in demand for follow-up endoscopies, which has unlocked operational and financial efficiencies.​

This award underscores our dedication to innovation and excellence in healthcare, reflecting our ongoing efforts to improve patient outcomes and streamline healthcare processes.​

We extend our gratitude to NHS Scotland for their collaboration and to the HSJ Partnership Awards for this award. We remain committed to advancing diagnostic services and improving patient outcomes through continuous innovation and partnership.

Read more from HSJ

Cyted Health has been awarded a contract for innovation to pilot an innovative diagnostic pathway aimed at improving early detection of oesophageal cancer in Wales and Northern Ireland. The funding, awarded under the SBRI Centre of Excellence and Innovation and Market Development Unit in Northern Ireland, will support the implementation of the EndoSign® capsule sponge test, a non-endoscopic diagnostic test designed to help reduce endoscopy backlogs and improve early detection rates.

The project will be delivered in collaboration with Cardiff & Vale UHB, Cwm Taf Morgannwg UHB, Belfast Health & Social Care Trust, and Western Health & Social Care Trust. It aims to demonstrate a sustainable model for integrating capsule sponge diagnostics into clinical pathways.

The initiative supports companies developing solutions to challenges in the health and social care system. This contract will enable Cyted to demonstrate how its EndoSign test can be integrated into routine clinical care across Wales and Northern Ireland, helping relieve pressure on endoscopy services and improve cancer detection rates.

Early detection of cancer is a national priority. Currently, over 12,000 patients in Wales and 16,000 in Northern Ireland are experiencing long waits for an endoscopy, often exceeding 14-26 weeks. These delays contribute to late-stage cancer diagnoses, which significantly reduce survival rates. This project will provide evidence for how innovative technology can address these issues at a national level.

This initiative directly supports national cancer strategies, including the Cancer Improvement Plan for NHS Wales and A Cancer Strategy for Northern Ireland both of which prioritise early diagnosis, workforce, and innovation.

Basirat Afinowi, Head of Projects at Cyted Health, said:

“This funding will enable us to demonstrate how innovative diagnostics can help the NHS tackle the challenge of late-stage oesophageal cancer diagnosis. The grant will allow us to work with NHS partners in Wales and Northern Ireland to embed EndoSign into clinical pathways and develop a blueprint for national adoption.”

The project will run until March 2025, with results contributing to policy decisions on scaling the technology nationally.

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Cyted Health today announces the appointment of Chris Freeman as a Strategic Advisor to the company, where he will advise on growth and US commercialization. 

Chris holds extensive experience in the delivery of successful commercialization strategies across the healthcare sector. As Chief Commercial Officer of Guardant Health, a Nasdaq-listed leading precision oncology company, Chris leads the company’s commercial function, which include multiple diagnostic tests across the cancer care continuum from early detection to post-treatment monitoring. Previously, Chris worked for ten years at Gilead Sciences, a biopharma company, where he served as Vice President of its $13 billion HIV treatment and prevention business, Elan Pharmaceuticals, and Genentech, where he spearheaded the marketing of its flagship oncology products. 

“The expertise Chris brings in leading large-scale commercialization strategies is unparalleled,” said Dr Marcel Gehrung, Cyted Health’s CEO and Co-Founder. “Cyted Health’s transformative technology is already modernising diagnostic pathways across the UK. Chris’ insights will be instrumental as we pursue significant opportunities ahead of us in the US and globally.”

“I am delighted to contribute my experience in healthcare leadership to Cyted Health as it builds its presence in the US,” said Chris Freeman. “EndoSign® and the accompanying molecular test are game-changing tools for the detection and monitoring of upper gastrointestinal conditions. It has vast potential in the US, and I am excited to be a part of this growth story”. 

Chris’s appointment marks the next step in Cyted Health’s work in the US following the appointment of Betsy Hanna as US President and FDA clearance for Cyted Health’s EndoSign® device in 2024.

University Hospitals of Leicester NHS Trust (UHL) has transformed patient access to diagnostics for Barrett’s oesophagus, a risk factor for cancer, through the roll out of capsule sponge testing. The team’s creation of a new nurse-led diagnostic pathway has allowed them to cut gastroscopy waiting times, improve clinical capacity and deliver a better experience for both patients and clinical staff. 

Leicester’s pioneering capsule nurses bring capsule sponge testing to the community

Nurses at University Hospitals of Leicester NHS Trust (UHL) have transformed patient diagnosis of the condition, by moving the procedure out of the hospital setting.

The move has seen a 20-week reduction in patient waiting times and has gathered positive feedback from patients.

How the test works

The capsule sponge test is available to patients with symptoms of gastro-oesophageal reflux disease such as acid reflux or heartburn and is being offered as a less invasive alternative to endoscopy.

The procedure involves patients swallowing a small capsule-shaped device that contains a tiny sponge.

The sponge then expands in the stomach and collects cell samples for analysis as it is being extracted via an attached string.

It can be used to diagnose Barrett’s oesophagus, a condition where oesophageal cells grow abnormally, which can lead to cancer if undiagnosed.

Introducing the test to Leicester

The NHS began piloting the test across trusts during the pandemic, due to increased pressure on services and a growing backlog for endoscopy.

Findings from the pilot, published this year, revealed that thousands of patients had benefitted from the sponge on a string test.

Nurses – who often perform the procedure in hospitals – have now paved the way for it to be undertaken in the community too.

At UHL, specialist nurses had noticed that the trust was facing all-time high waits for gastroscopy and wanted to introduce the capsule sponge test out in the community to combat it.

Initially it was rolled out at St Luke’s Hospital in Market Harborough, and has since been extended to two further community hospital sites.

Capsule sponge nurse feedback

Colette Green, a community matron at the trust, told Nursing Times that when they initially began the rollout in the community, they were fitting it around their usual workload at the hospital.

“We didn’t get any extra time or funding when we originally started,” she explained.

“As with a lot of these things, sometimes you have to take a bit of a risk.”

Ms Green noted that the procedure was “better for patients and gets done a lot quicker” because there is no need for sedation.

In addition, she said it was a cost-saving procedure because it just requires one nurse and their equipment.

Creating a nurse-lead capsule sponge clinic

Following a funding injection, the trust decided to create a permanent nurse-led clinic to undertake the procedure across different community hospital sites.

The nurses now work within a 17-mile radius of the city to undertake the procedure.

Vanessa de Vivian, lead capsule sponge clinical nurse specialist at the trust, told Nursing Times that the pilot had provided her with the opportunity to be upskilled.

She noted that, in some cases, band 6 endoscopy nurses were “very limited” in where and how they could progress.

“I was looking at alternative employment and what I could do to specialise,” Ms de Vivian explained.

“Then we fell upon this, and it’s something that I am passionate about, and I’ve now gone from a band 6 to a band 7, leading the service and setting up a service – it is absolutely fantastic."

She added: “It’s nice to have the opportunity to actually work independently.

 “People have confidence in us as nurses, to allow us some scope to be able to do that.”

So far, the team has done the procedure on more than 560 patients and have received lots of positive feedback.

It has resulted in a 20-week reduction in patient waiting times, as well as making testing available to more sites across Leicester.

All patients who previously had other gastroscopy procedures said they would prefer to have a capsule sponge test in the future.

Meanwhile, 99% of patients said they experienced little to no discomfort during or after their capsule sponge test.

UHL has plans to expand the reach of the community-led sponge on a string test.

Expansion plans

Ms Green said the trust was looking to take on more band 6 nurses to carry out the procedure in the community.

“It frees up the clinicians and nurse endoscopists to concentrate on the more complex procedures and things that need to be done in an endoscopy room in an acute setting,” she explained.

Meanwhile, the trust is working to change the criteria for referrals from GPs so that they can directly refer patients to have the sponge on a string procedure.

The vision is that, in time, capsule sponge testing will be offered as a first-line diagnostic procedure for those with gastro-oesophageal reflux disease.

It comes as there are still many people in the community self-medicating for acid reflux who should be offered a test, explained Ms de Vivian.

“There’s many people undiagnosed with Barrett oesophagus,” she said.

“Obviously we know in the medical field that that can lead to oesophageal cancer.”

Separately, Ms de Vivian noted that other hospital trusts had taken an interest in UHL’s work.

She said that she had so far attended meetings with six nearby hospital trusts to see how the procedure could be replicated at other organisations.

Ms de Vivian said: “I think it’s really good if you get nurses with a passion who are already doing [gastroscopy].

“I believe in it, and I think it should be [rolled out] across the UK.”

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Read the article 

The Summer edition of Gastroenterology Today features two articles that demonstrate how capsule sponge testing can improve the clinical capacity of endoscopy teams.

Read the summary below or see the full publication on the Gastroenterology Today website.

Leicester Case Study

‍The Challenge

University Hospitals of Leicester NHS Trust (UHL) has transformed patient access to diagnostics for Barrett’s oesophagus through the roll out of a nurse-led capsule sponge testing pathway. Implementing capsule sponge testing has allowed them to cut gastroscopy waiting times, improve clinical capacity and deliver a better experience for both patients and clinical staff.

The team at UHL had an ambition to reduce wait times and improve survival chances for a lesser-known group of patients with Barrett’s oesophagus that affects around 1 million adults in Britain. However, the team were facing all-time high waits for gastroscopy and saturated 2-week wait pathways, placing these patients at increased risk of late diagnosis.

● Average patient wait time for this group: 6-12 months

● Number of staff able to perform the initial diagnostic test: 1

● Number of locations the initial diagnostic test was available from: 1

The Solution

Testing was undertaken by a range of clinical professionals from nurses to consultants – widening the possible delivery of the service - which provided the potential to reduce the wait associated with traditional endoscopist-led endoscopy procedures. The team also improved their triaging process for the test, adding electronic forms to improve the speed and accuracy of patient selection. Capsule sponge testing offered the opportunity for nurses to be upskilled, providing improved career pathways which the team felt would strengthen both their attraction and retention. By improving their capacity to deliver the service, and upskilling their team, the Trust was able to create a nurse-led clinic that could see more Barrett’s patients, more quickly.

“What started as two nurses with an idea has become a key part of our pathway and now my full time job! The training opportunity alone has helped position ourselves as an innovative service that people are excited to join. Our staff retention has improved and we’re already hiring for more as we plan to roll out capsule sponge testing for other patient groups, and look to GP referrals to reach even more people. Our vision is that in time, all patients for Barrett’s surveillance and investigation for GORD will be offered capsule sponge testing as a first line diagnostic procedure.” Vanessa deVivian, Capsule Sponge Lead Nurse Specialist

Key Findings

● 20 week reduction in patient waiting times.

● Increased capacity, with 3 staff able to perform the test. One dedicated full-time nurse and two other part-time.

● Testing now available to more sites across the Trust and expanding into community care.

● The early detection of Barrett’s oesophagus has helped to prevent the occurrence of oesophageal cancers.

● Positive impact on staff retention and acquisition, with colleagues expressing how valued they feel.

● Cost reduction of around 50% compared with gastroscopy, due to the different skill mix, setting and product.

The Trust’s nurse-led model demonstrates a clear way for other services to reduce the pressure on endoscopy teams, while still offering exciting training opportunities and autonomy to those that want to innovate. By expanding the deliverability of the testing, UHL is leading the way in developing cost-effective, nurse-led services that can provide better access, experience, and outcomes for patients.

For further details, or to discuss how Cyted Health can support your service in creating a capsule sponge pathway, please get in touch.

Managed Service Support

For Trusts that want to take advantage of the capacity boost that capsule sponge offers, but need extra workforce support, managed services company Xyla has put forward an example patient pathway featuring their insourced.

Read the full article here.

Cyted Health today announces the appointment of Betsy Hanna as US President, where she will lead the company’s expansion into the US market. Betsy joins the company at a pivotal time, following FDA clearance for Cyted Health’s EndoSign® device earlier this year.

Betsy brings more than 20 years of healthcare executive leadership experience for diagnostics and medical device companies including genomic testing in oncology. She has a track record of leading strategy, marketing, and commercialization in global businesses and innovative start-up companies, successfully launching new products in the US and beyond. Betsy previously served as Agendia Precision Oncology’s Chief Commercial Officer and Executive Vice President. She received her MBA at Harvard Business School and holds a degree in Chemical Engineering from the University of Illinois.

“Betsy joins us to take on the significant work already underway to bring our products to the US market,” said Dr Marcel Gehrung, Cyted Health’s CEO and Co-Founder. “This is a crucial moment in what will be a core market for Cyted Health’s work, and Betsy will bring deep expertise and considerable experience to grow our presence in the US. She will be invaluable for guiding our team through successful commercialization and her appointment is another step to expanding our footprint globally.”

The FDA’s clearance of EndoSign® in February was one of a series of recent milestones achieved by Cyted Health in the US. It followed a partnership with Devyser Genomic Laboratories to conduct the lab analyses announced in January. In November last year, Gail Marcus was appointed Chair of the Board, bringing her vast knowledge of the US healthcare system and supporting Betsy to deliver this year’s strategic plan.

Cyted Health is a gastrointestinal health company that has developed EndoSign®, a minimally invasive test to detect and monitor for signs of pre-cancer and other diseases. Testing can be completed in minutes in a nurse-led clinic. EndoSign® is already widely used across the UK to identify Barrett’s esophagus – a precursor to esophageal cancer – and the risk of patients developing cancer in the future.

“I look forward to leading Cyted Health’s US arm and contributing to the fight against esophageal cancer,” said Betsy Hanna. “EndoSign® can transform current methods for monitoring patients and make sure conditions are detected earlier and treated faster. I am highly confident that we can make a significant impact bringing this technology to US patients.”

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Read the full case study here.

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The national implementation of capsule sponge testing in Scotland has delivered significant improvements for the care of upper gastrointestinal patients. The testing programme launched in 2020 to improve the quality of care and diagnostic waiting times for patients with Barrett’s oesophagus and those at risk of oesophageal cancer.

The challenge

The onset of the COVID-19 pandemic interrupted Scotland’s endoscopy services, resulting in insufficient capacity to deliver timely procedures for patients requiring surveillance for Barrett’s oesophagus. Delays to surveillance increase the risk of cancer progression being missed until the later stages. This prompted the search for non-endoscopic options with strong clinical evidence, with NHS Scotland opting to use the capsule sponge test.

The solution

During the pandemic NHS Scotland began the national-level implementation of capsule sponge testing, to find a way to fast-track patients with signs of cancer for treatment and schedule patients at medium-to-low risk for their next surveillance procedure appropriately. As of January 2024, over 6000 tests have been performed throughout Scotland, with the test acting as a triage tool to identify patients requiring further investigation with endoscopy.

Key findings

Capsule sponge testing has cut patient waiting times significantly for NHS Scotland, while enriching endoscopy lists and boosting dysplasia detection rates to help clinicians identify more at-risk patients. This has released endoscopy resources for other complex procedures, such as bowel cancer screening.

• Using the test for screening has helped Scotland reduce the demand for follow up endoscopies by 77%.
• A national evaluation predicted cost savings of £700k in the first year and £3.3m over 5 years.
• NHS Scotland reduced median waiting times for endoscopy from 9 months to 5 months.
• From under 10% to over 50% concerning pathologies found at endoscopy.

Conclusion

By delivering high-quality care with fewer endoscopies, NHS Scotland has demonstrated what state-of-the-art Barrett’s surveillance could look like, prompting clinical teams across the UK and Europe to consider how to make a difference in the earlier detection of oesophageal cancer.

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• Cyted and Microsoft Research collaborated to build novel AI models for efficient screening of cancer cells that could reduce pathologist workload by as much as 63%
• Nature Communications published an article detailing the research

Cambridge based health company Cyted announced a publication in Nature Communications on research conducted in collaboration with Microsoft Research developing machine learning tools to enable earlier and faster detection of Barrett’s esophagus, a precursor to cancer.

“We have been delighted to collaborate with Microsoft Research to push the boundaries of what’s possible in medical imaging and screening technologies, creating optimal efficiencies from start to finish of the testing process” said Dr Marcel Gehrung, CEO and Co-founder at Cyted. “As we continue to expand, machine-learning will be an important tool to support our goals and make early cancer detection more accessible."

Esophageal cancer is one of the deadliest cancers with a five-year survival rate of less than 15%. Detecting Barrett’s esophagus, a precancerous condition, helps identify patients who are at a higher risk of developing esophageal cancer. Monitoring patients with this condition offers the best chance of early cancer detection and therefore earlier treatment of esophageal cancer, dramatically improving survival rates to 9 in 10 people surviving after 5 years.

The article titled “Enabling large-scale screening of Barrett’s esophagus using weakly supervised deep learning in histopathology” is an example of the innovative research that Cyted and Microsoft Research are advancing to optimize clinical workflows and improve the capabilities of earlier identification of cancer with technology.

Cyted’s capsule sponge technology, EndoSign® is a non-endoscopic test that collects cells from the esophagus in a process that takes less than ten minutes. Analysis of these cells is conducted by pathologists to identify biomarkers - a measurable biological indicator of the likelihood of a cancer developing.

Artificial Intelligence is being used to optimize the screening process by leveraging machine learning to help triage the large sets of pathology images. This saves precious pathologist time by screening out negative cases and controlling the quality of digitalized samples, cutting the pathologist’s workload down by as much as 63%.

“Microsoft Research seeks to advance science and technology to benefit humanity, often by identifying new applications for leveraging AI and machine learning,” said Javier Alvarez-Valle, Senior Director of Biomedical Imaging at Microsoft Research. “Collaborating with Cyted and sharing our work via open source will empower researchers and clinicians around the world to leverage this technology in their fight against cancer.”

The full article in Nature Communications can be viewed here.

A blog post written by Microsoft Research can also be found here.