FDA approves breath test for diagnosis of gastroparesis
The FDA today approved the Gastric Emptying Breath Test, or GEBT, a novel noninvasive diagnostic for gastroparesis, according to a press release.
“The GEBT [Advanced Breath Diagnostics] is another option for aiding in the diagnosis of gastroparesis,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release. “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.”
According to the release, the GEBT is conducted over four hours after an overnight fast, and measures carbon dioxide in a patient’s breath to show how fast the stomach empties solids. After a baseline breath test, patients eat a special meal that includes Spirulina platensis enriched with carbon-13, which is then measured in breath samples.
This approval follows positive results from a clinical study involving 115 patients who would typically undergo a gastric emptying test, the release said. All patients underwent GEBT and gastric scintigraphy, and the researchers compared results from both modalities. Both results agreed between 73% to 97% of the time at various points. No serious adverse events occurred.