Non-invasive cell-sampling device to detect Barretts Esophagus
EsoCheck is a rapid office-based alternative to diagnostic endoscopy that combines a non-invasive cell sampling device with a DNA biomarker test. Together these have been shown to be highly accurate in detecting Barrett’s Esophagus, the primary precursor to the most common and lethal form of esophageal cancer caused by Gastroesophageal Reflux Disease (GERD), commonly known as heart burn or acid reflux.
In a simple five-minute test, the patient swallows a vitamin pill-sized capsule containing a small inflatable balloon attached to a thin catheter. As the catheter is withdrawn, it swabs the target area for a sample of cells and protects that sample from contamination as the device is removed. The sample is then tested for a panel of methylated DNA biomarkers that have been shown to be highly accurate in detecting Barrett’s Esophagus. These data were recently published in a seminal report on a multicenter human clinical study (Moinova, et al. Science Translational Medicine 2018 Jan 17;10(424)).
Swallow
Instead of undergoing standard endoscopy, patients can swallow a pill-sized capsule attached to a thin silicone catheter. The capsule passes through the esophagus and stops near the stomach.
Inflate and Collect
Once the capsule nears the stomach,
a balloon with a textured surface is inflated
and maneuvered to swab the lower esophagus, where Barrett esophagus (BE) typically begins.
A sample of the cells lining the lower esophagus is collected.
Invert and Retrieve
inverted back into the capsule, thus protecting the sample from dilution or contamination. After retrieving the capsule through the mouth, DNA is extracted from the balloon’s surface for a DNA methylation test.
PAVmed Subsidiary signs Definitive Agreement for EsoCheck Technology.
Pursuant to the licensing agreement, newly-formed PAVmed subsidiary Lucid Diagnostics Inc. now owns the exclusive worldwide right to develop and commercialize both the EsoCheck cell sampling device and the DNA biomarker test, as well as additional related intellectual property.
“EsoCheck is a revolutionary technology that we believe will save many lives through the early detection of pre-cancerous conditions of the esophagus including Barrett’s Esophagus,” said PAVmed Chairman and CEO Lishan Aklog, M.D. “We are proud to have been selected to be the exclusive commercial partner of Case Western Reserve University in this important endeavor. Based on the dramatic results of the recently published multicenter clinical study, we believe widespread EsoCheck screening has the potential to have as great an impact on esophageal cancer as widespread Pap screening has had in preventing cervical cancer, targeting an estimated immediately addressable domestic market of several billion dollars.”
A large multicenter National Institutes of Health (NIH) study of EsoCheck is underway and actively enrolling patients at Case Western Reserve University Hospital and other leading academic medical centers including the Cleveland Clinic, Johns Hopkins, Mayo Clinic, Washington University St. Louis and the University of North Carolina.
“Our multicenter NIH study aims to establish the clinical evidence for EsoCheck’s widespread use as a screening test to detect Barrett’s Esophagus, eventually targeting the estimated 50 million Americans with and without heartburn who are at risk,” said principal investigator and EsoCheck co-inventor Amitabh Chak, M.D., professor of medicine at Case Western University School of Medicine, gastroenterologist at UH Digestive Health Institute, director of the Advanced Technology & Innovation Center of Excellence at University Hospitals Division of Gastroenterology and editorial board chair of Gastrointestinal Endoscopy, the preeminent journal in the field.
“The EsoCheck device is already being manufactured for human use in clinical trials and the EsoCheck DNA biomarker test is already being performed at a reference laboratory, which expects to receive CLIA certification later this year. As such, we will be able to aggressively pursue EsoCheck commercialization by seeking U.S. Food and Drug Administration (FDA) 510(k) clearance of the cell sampling device and a Laboratory Developed Test designation of the DNA biomarker test,” Dr. Aklog said. “We are targeting the first quarter of 2019 for the launch of the first commercial product in the U.S.”
About GERD, Barrett’s Esophagus and Esophageal Cancer
Esophageal adenocarcinoma (EAC) is the most common cancer of the esophagus whose incidence has risen many fold over recent decades. Its prognosis remains dismal with a five-year survival of less than 2 0%.
The primary cause of EAC cancer is GERD, commonly known as heartburn or acid reflux, where stomach acid refluxes into the lower esophagus. According to published epidemiological data, an estimated 15- 30% of adults suffer from GERD symptoms at least once per week. Repeated exposure of the lower esophagus to refluxing acid can lead to Barrett’s Esophagus, a transformation of the lower esophageal lining, which is a precursor to precancerous dysplasia and ultimately EAC cancer itself. Nearly all
patients diagnosed with EAC cancer have evidence of Barrett’s Esophagus, but only 10% have it detected prior to EAC cancer. Barrett’s Esophagus can be successfully treated, usually with non-surgical approaches, if detected before EAC cancer develops.
Upper gastrointestinal endoscopy is the standard diagnostic test for Barrett’s Esophagus, but it is expensive, invasive and requires intravenous sedation. In addition, microscopic analysis of endoscopic samples depends on assessment by a pathologist, which is also expensive and not fully automatable. As a result, widespread screening for Barrett’s Esophagus using endoscopy is neither practical nor cost- effective. There is an urgent unmet clinical need for a highly accurate, non-invasive alternative to endoscopy that utilizes modern automated genetic tools to detect Barrett’s Esophagus and prevent highly lethal progression to EAC cancer.
*PAVmed has not yet received clearance from the FDA or any other regulatory agency for the EsoCheck device.