MONDAY, April 6, 2015 (HealthDay News) — A new breath test has been approved by the U.S. Food and Drug Administration to help doctors diagnose a condition called gastroparesis, a delay in emptying of stomach contents to the small intestine.
Previous tests have been more invasive, involving use of small amounts of radioactive material, the FDA said Monday in a news release. This required that testing be done in a specialized outpatient facility.
The GEBT breath test, on the other hand, can be administered in the doctor’s office, and is conducted over a four-hour span after an overnight fast. It allows doctors to see how fast the stomach empties solids by measuring carbon dioxide content in a person’s breath, the FDA said.
Gastroparesis results from damage to the vagus nerve that controls the muscles of the stomach and small intestine. It can occur after gastrointestinal surgery, among diabetic patients with high blood sugar, or as a result of neurologic conditions such as Parkinson’s disease or multiple sclerosis, the agency said.
The new test was compared to an older diagnostic among 115 clinical trial participants. The GEBT test was found between 73 percent and 97 percent accurate, the FDA said, depending on when the measurement was obtained during the four-hour span.
The new test is manufactured by Advanced Breath Diagnostics, based in Brentwood, Tenn.
More information
The FDA has more about this approval.
Copyright © 2024 HealthDay. All rights reserved.