This story has been updated to clarify the nature of Cyted's planned neoplasia detection assay.
NEW YORK – Esophageal cancer testing firm Cyted Health said last week that it has begun enrollment of a new clinical validation study called DETECT-ME to build evidence and drive adoption of its molecular test for Barrett's esophagus and esophageal cancer.
Cyted's test, which uses a proprietary capsule-based sample collection device called EndoSign, has already been widely adopted in the UK, with a demonstrated impact on earlier-stage cancer detection and improved patient outcomes, according to Marcel Gehrung, Cyted's cofounder and CEO.
Gehrung said in an interview that data indicate that 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 percent.
To a certain extent, it is fortunate that this cancer has a known and identifiable precursor in Barrett's esophagus, Gehrung said.
"Unfortunately, although we know that [BE] is associated with an up to 50 times increase in the risk of developing esophageal cancer, we only identify about 10 percent of those that have it," he added. As such, most esophageal cancers are detected late.
"Virtually all of them had Barrett's, but we [haven't been] very good at finding the right patients at the right time" with traditional methods, Gehrung said.
The new US trial will enroll individuals across 18 sites in the US and is being led by principal investigators Nick Shaheen from the University of North Carolina School of Medicine and Sachin Wani, executive director of the Rady Esophageal & Gastric Center of Excellence at the University of Colorado Anschutz Medical Center.
The company hopes that the data will complement existing evidence as it seeks Medicare reimbursement and works to drive adoption.
Cyted's platform involves a sample collection device that employs a swallowable capsule with a retrieval line that dissolves in the stomach, where it expands into a small sponge. It's then drawn back up, collecting cells from the full length of the upper GI tract.
With this sample, the company can do two things. First, it can analyze the cells for biomarkers in order to detect the presence of Barrett's. Secondly, in patients already known to have the precursor condition, it can look for separate molecular signals that indicate progression to esophageal cancer.
In a statement, Shaheen said that DETECT-ME "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."
In the UK, Cyted has explored both proteomic and genomic approaches, but Gehrung said that the firm's strategy in the US is focused solely on detecting epigenetic signals.
Offered through the company's CLIA-certified lab outside of Atlanta, the US EndoSign test is a methylation sequencing assay that analyzes differential methylation patterns across proximately 80 genomic regions.
Early in the company’s efforts, it published a large, randomized trial in the Lancet that essentially showed that you can find 10 times more patients with BE among the population with risk symptoms, Gehrung said.
Around the same time, the firm had its first funding round but decided to further explore ideal biomarkers rather than speed a test to market.
"But when COVID started, there was a very notable unmet need that was created in the UK, which was that endoscopy capacity essentially fell to zero. So, many of these patients were simply not seen anymore. The only patients that got an endoscopy were those who needed one urgently," Gehrung said.
The company was able to quickly partner with the UK's National Health System and "essentially parachuted the technology" into the gastroenterology care pathway as a test for patients unable to have an endoscopy.
"We didn't only get really good adoption in the UK and really interesting real-world evidence coming out of this because of COVID, but also the standard of care has really significantly evolved and non-endoscopic testing is now deeply ingrained in the UK clinical pathway for managing this disease," he added.
"It lets us be smart about which patients need an endoscopy and how a gastroenterologist's time is best spent in terms of intervention and treatment."
Betsy Hanna, Cyted's president and US general manager, said that the BE-detection version of EndoSign has been available in the US for about a year.
In this arena, the firm's main competitor is Lucid Diagnostics, which has also developed a capsule-based device to collect cells for downstream molecular analysis.
Gehrung said that Lucid's device works differently than Cyted's, collecting cells from only the distal end of the esophagus. As such, he believes his firm may see an advantage, especially in the potential to capture additional molecular signals in the future.
He said that another advantage is that the company has already used the test on more than 30,000 patients and thus has "a very, very good understanding of not only safety, tolerance, and acceptability, but how the technology actually operates in the field when it's deeply embedded in the clinical pathway."
"A non-endoscopic test has to be intentional about where it fits in the pathway and how it sits alongside endoscopy because at the end of the day … it doesn't replace endoscopies … but it helps us use the endoscopic resource in a much more intentional way," Gehrung added.
In terms of insurance coverage, Hanna said the firm is currently in the process of finalizing its evidence package to submit the test to Medicare contractor Palmetto through the MolDx program.
Meanwhile, Hanna said that the firm's neoplasia test, which indicates progression to esophageal cancer, is currently in its "final design lockdown."
"We're all watching what's happening with the legislation around [US Food and Drug Administration] oversight there, but as of right now, that would be our second LDT," she said.
Other firms in the esophageal cancer testing market include Previse and Castle Biosciences. Both companies' tests are performed on biopsy samples obtained via endoscopy, although Previse has stated its intentions to develop a capsule-based approach. Neither would be a direct competitor to Cyted's neoplasia assay because they are designed to predict the risk of esophageal cancer rather than identify its emergence.
Gehrung said the firm also has a research program ongoing to explore use of its capsule collection device for other diseases, including eosinophilic esophagitis, which is an inflammatory disease of the esophagus.
He argued that this is something that really necessitates a technology like Cyted's which obtains a sample from the entire esophagus. In the future, the platform could potentially provide a "full picture" of the upper gastrointestinal system, allowing investigation of the interplay between cancer, inflammation, and other aspects of biology like the microbiome.