Out of the aggressive forms of cancer, esophageal cancer is one that often remains asymptomatic until the later stages of the disease—making it extremely lethal by the time it’s finally diagnosed. In the United States alone, 16,170 deaths have occurred out of 18,440 new cases in 2020 (that’s a death rate of 88 percent). The incidence of esophageal cancer has been rising steadily over the past few decades, making it increasingly important to find ways to detect the disease early.
Until recently, an upper endoscopy has been used to view the lining of the esophagus and diagnose cancer. This involves passing an endoscope—i.e., a tube with a light and video camera on the end—down the throat while the patient is sedated. The test is costly and invasive, requiring the patient to lose a day of work while needing a companion for transportation.
Researchers from Case Western Reserve University and University Hospitals Cleveland Medical Center have developed a cell collection device called EsoCheck that helps detect precancerous changes in the esophagus in a non-invasive five-minute office-based procedure without the need for patient sedation.
The EsoCheck medical device comprises a small capsule that contains a textured balloon for enhancing cell collection. The patient swallows the vitamin-sized capsule, which is attached to a thin, 68-cm-long silicone catheter with 5-cm markings to indicate when the capsule has reached the stomach. The doctor performing the procedure then inflates the balloon by blowing air through a syringe, exposing the ridges that will swab the targeted area of the esophagus. After the cells are collected on the balloon’s surface, the doctor withdraws the balloon back into the capsule using the syringe, in order to protect the sample from dilution and contamination during device retrieval. The balloon is placed in a preservation solution and the DNA is subsequently analyzed for Barrett’s Esophagus (BE), a known precursor to Esophageal Adenocarcinoma (EAC).
When carried out in conjunction with the EsoGuard esophageal DNA test, the EsoCheck test has been found to demonstrate over 90 percent accuracy in detecting BE. The device is additionally useful in the diagnosis of Eosinophilic Esophagitis (EoE), an allergy-mediated inflammatory condition of the esophagus often associated with inflammatory bowel disease (IBD).
The U.S. Food and Drug Administration (FDA) has approved both the EsoCheck cell collection device and its companion EsoGuard molecular assay, which are now being produced by Lucid Diagnostics. The EsoCheck device was named a Silver winner in the medical testing solutions category of the 2020 Edison Best New Product Awards.