EsoCheck™ & EsoGuard™: Revolutionary Invention Transforms Esophageal Cancer Diagnostics, Widens the Scope of Barrett’s Esophagus Screenings and Esophageal Cancer Prevention
April 28, 2025
Innovations in Research | May 2025
Earlier this year, a consortium led by Principal Investigators from University Hospitals (UH) and Case Western Reserve University (CWRU) was awarded an $8 million National Institutes of Health (NIH) RO1 grant to conduct a five-year clinical study to evaluate esophageal precancer detention, or Barrett’s Esophagus (BE), using the EsoCheck® Esophageal Cell Collection Device and EsoGuard® Esophageal DNA Test.
Amitabh Chak, MD
Sanford Markowitz, MD, PhD
Joseph Willis, MDBE is a change in the lining of the normal esophagus that increases the risk of esophageal cancer. The new, state-of-the-art, minimally invasive technologies will be used to screen and identify patients at risk of developing esophageal cancer (EAC), specifically at-risk individuals without symptoms of chronic gastroesophageal reflux disease (GERD), who meet the American Gastroenterological Association’s criteria for screening. The study will enroll 800 participants recruited from UH, the University of Colorado, John Hopkins University, University of North Carolina, and Cleveland Clinic.
“Our team has been working aggressively on esophageal cancer prevention work for over 20 years,” says Amitabh Chak, MD, a gastroenterologist at UH and the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery at UH Seidman Cancer Center, and Professor of Medicine and Oncology at CWRU School of Medicine. Dr. Chak stated, “We are truly excited at the chance of advancing these potentially life-saving technologies, which could increase the number of people who receive esophageal precancer screening and provide fresh hope for esophageal cancer prevention.”
Dr. Chak is collaborating with Sanford Markowitz, MD, PhD, the study’s Principal Investigator and the Ingalls Professor of Cancer Genetics at the School of Medicine; Joseph Willis, MD, a Professor in the Department of Pathology at the School of Medicine; and, Helen Moinova, PhD, an Instructor at the School of Medicine.
The techniques involved in the study are designed so physicians can quickly and non-invasively gather surface esophagus cells for analysis without endoscopy by using EsoCheck® technology. The EsoCheck® capsule, which resembles a gel cap, is connected to a thin catheter, and is swallowed by patients to retrieve esophageal cells. The EsoGuard DNA test is used to identify abnormal esophageal cells to diagnose BE before it progresses to cancer.
The Power of New Technology and Techniques Could Save Lives
The test can be done in five minutes in an office setting without sedation. Currently, less than 10% of BE is detected. Use of EsoCheck™ & EsoGuard™ would enable more widespread screening by testing patients in an office-based setting. While the new technology will not replace endoscopy, it makes endoscopy more effective.
“Patients with a positive test still need endoscopy, but now the endoscopy has a much higher yield,” says Dr. Chak. Right now, based on clinical variables, only 7-10% of patients who are screened are found to have BE. However, when using endoscopy on patients who are EsoGuard™-positive, the yield in patients is over 30%, according to Dr. Chak and his research colleagues.
Screening is recommended for individuals with multiple risk factors, including white males above the age of 50 years with a family history of BE or EAC, who are obese, and/or smoke. Use of the EsoCheck™ & EsoGuard™ technologies could ultimately broaden screening to those without GERD symptoms, says Dr. Chak.
To date, physicians have used endoscopy to detect BE and, if present, continue monitoring the condition to prevent cancer, or intervene with when dysplasia develops by cutting, burning, or freezing it out. However, most at-risk patients never undergo endoscopy, and their BE is not detected before they progress to cancer. Similarly, more than 40% of people who develop EAC do not have the symptoms of GERD that would bring them to a physician’s attention, says Dr. Chak. Better approaches are needed to screen more individuals at risk of BE, especially those who do not have GERD, before it progresses to cancer, to advance the field.
Years of Collaborative Team Science Generate Multiuse Screening and Diagnostic System
For years, Dr. Markowitz, a noted cancer genetics expert, worked on obtaining DNA from stools as a means of detecting individuals with colon cancer. It was Drs. Chak and Willis in the NCI Center for GI Cancers at UH and CWRU that challenged him to apply the same approach to advancing the field of EAC because better screening methods were needed. They said, “Why are you stuck in the colon? Can’t you move up the gut a little bit and do something about this disease in the esophagus,” Dr. Markowitz recalls.
To get started, the researchers used biopsy tissue to develop a DNA signature for EAC, which became the EsoGuard™ panel, and could distinguish between normal, BE, or EAC cells, identifying changes in the epithelium that signaled BE. They found two methylated markers, CCNAI and vimentin, two genes that were abnormally changed by a process called methylation. The presence of these methylated DNA signatures in routine biopsy samples allowed them to serve as biomarkers in tissue brushings to identify BE.
Next, the researchers came up with the concept of developing a balloon that would be blown up in the stomach to sample the distal esophagus, where BE resides without the need for an upper endoscopy. Subsequent clinical trials at UH confirmed the technologies’ ability to effectively screen patients and identify those at risk of developing BE. Upon publication in Science Translational Medicine, the innovative screening approach drew the attention of potential investors and commercialization entities, including Lishan Aklog, MD, CEO of Lucid Diagnostics. He saw opportunities to commercialize Eso technologies and mobilized funding for the necessary studies.
Since then, the EsoCheck® Esophageal Cell Collection Device and EsoGuard® Esophageal DNA Test have received FDA approval. The DNA panel received FDA breakthrough device designation. Separately, screening with the new diagnostic system is covered under Medicare, which enables physicians to prescribe and bill for screening, and widens the path for securing commercial health insurance coverage. Additionally, two key professional societies, the American College of Gastroenterology (ACG), and the American Gastroenterological Association (AGA), updated their guidelines for BE and to include this technology. To date, the new screening approach, has been used in more than 11,000 Americans.
Moving Forward
Lucid is promoting the use of EsoCheck™ / EsoGuard™ for BE screening, to boost profitability, and maximize the technology’s potential benefit. The company is using innovative approaches broadcasting to patients who have heartburn, trying to get those patients screened.
“Moving forward, we have to devise ways to find ways to find patients that should be screened, to identify those who either have Barrett’s Esophagus or are going to develop precancer,” says Dr. Willis. “And that's a big deal, because if we say about 2-3% of the population actually have Barrett's esophagus, and we want to identify those, that's several million patients.”
Future research will examine how to improve adoption of the new screening technology among primary care physicians and how to increase its acceptance in patients. Additionally, further study will determine if screening can prevent cancer, says Dr. Chak. Long-term, the new technology could improve screening in underserved areas and prevent at-risk populations from developing cancer, added.