Sunday, April 12, 2015
FDA approves breath test to aid in diagnosis of delayed gastric emptying
The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.
Current tests used to diagnose gastroparesis typically involve the use of a small amount of radioactive material or imaging equipment, so testing must be conducted in specialized outpatient centers. The GEBT can be used in broader settings.
“The GEBT is another option for aiding in the diagnosis of gastroparesis,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “It can be performed in any clinical setting since it does not require the health care professionals administering the test to undergo special training or to take special precautions related to radiation emitting compounds.”
Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine when muscles in the stomach are not contracting properly. It is caused by damage to the vagus nerve that controls the muscles of the stomach and small intestine, often as a result of intestinal surgery, neurological diseases such as Parkinson’s disease and multiple sclerosis, or high blood glucose levels due to diabetes. If left untreated, gastroparesis can lead to problems such as severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in people with diabetes, and malnutrition due to poor absorption of nutrients or a low caloric intake.