Univ. Licenses Barrett’s Esophagus Detection Device

(PDPics, Pixabay)

16 May 2018. A medical device company is licensing a minimally-invasive technology developed in university labs for detection of Barrett’s esophagus, a condition that often leads to esophageal cancer. The agreement with PAVmed Inc. in New York, gives Case Western Reserve University, whose researchers invented the device known as EsoCheck, an equity stake in Lucid Diagnostics, a PAVmed subsidiary that plans to further develop and commercialize the technology.

Barrett’s esophagus is a condition where tissue similar to the lining of the intestine develops in the esophagus, the tube connecting the mouth to the stomach. The disorder is often found in people who also experience long-term acid reflux disease, where acid is regurgitated into the lower esophagus, marked by frequent heartburn and difficulty in swallowing. While only small percentages of people with acid reflux disease develop Barrett’s esophagus, the latter condition increases the risk of esophageal cancer.

The university says cases of esophageal cancer quadrupled in the past 30 years, with only 1 in 5 cases surviving as long as 5 years after diagnosis. In addition, nearly all cases of esophageal cancer show signs of previously undetected Barrett’s esophagus. But if diagnosed early, Barrett’s esophagus can be treated successfully with treatments that do not require surgery. Current diagnostic techniques, however, require insertion of an endoscope into the esophagus that gives a real-time view of the tissue, but also requires sedation, and a separate review by a pathologist.

The EsoCheck device collects cells from the esophagus that are then tested for biomarkers indicating Barrett’s esophagus in a test taking about 5 minutes. Patients are ask to swallow a capsule the size of vitamin pill attached to thin silicone catheter wire. In the stomach, the capsule is retracted to the esophagus, where it releases an inflatable balloon. The balloon is retracted further, enabling the balloon to collect cells from the esophageal lining, then deflated and recovered from the patient. Cells collected by the balloon are analyzed for DNA indicating the presence of Barrett’s esophagus.

EsoCheck is a creation of 3 researchers and physicians at Case Western Reserve or University Hospitals affiliated with Case Western Reserve. Sanford Markowitz is a professor of cancer genetics at Case Western Reserve’s medical school. Amitabh Chak is also on the faculty at Case Western Reserve’s medical school as well as a gastroenterologist at University Hospitals. Joseph Willis, is professor of pathology and pathology vice chair for clinical affairs at University Hospitals.

The developers tested EsoCheck in a clinical trial enrolling 150 individuals suspected of Barrett’s esophagus, with Chak serving as the lead scientist. The results, published in January 2018, show EsoCheck provides comparable detection capabilities as an endoscope, and is well tolerated by patients.

PAVmed is receiving an exclusive license to commercialize EsoCheck from Case Western Reserve. The company is forming Lucid Diagnostics, a separate subsidiary, to further develop the technology and take it to market. The license agreement provides Lucid Diagnostics with all assets related to EsoCheck, including diagnostic software, and allows the company to adapt the technology for disease monitoring and prognosis. In return, Case Western Reserve gains an 18 percent equity stake in Lucid Diagnostics and will be eligible for royalties from revenues on sales of EsoCheck-related products, and a percentage of other revenues.

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