New Breath Test for Gastroparesis Approved by the FDA

The Food and Drug Administration (FDA) has approved the Gastric Emptying Breath Test (GEBT), a non-invasive test to aid in the diagnosis of delayed gastric emptying (gastroparesis).

Unlike current tests for diagnosis of gastroparesis that require the use of radioactive material or imaging equipment in specialized outpatient centers, the GEBT can be performed in a wider range of clinical settings. The GEBT is conducted over a four-hour period following an overnight fast and is designed to show how fast the stomach empties solids by measuring carbon dioxide in a patient's breath. After baseline breath tests, patients eat a special test meal that includes a scrambled egg-mix and Spirulina platensis, a type of protein that has been enriched with carbon-13. By adding carbon-13 to the test meal, the GEBT can determine how fast the stomach empties the meal by measuring the ratio of carbon-13 to carbon-12 collected in breath samples at multiple time points after the meal is consumed vs. baseline measurement.

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The approval is based on a clinical study of 115 participants who would typically undergo a gastric emptying test. All participants underwent testing with both the GEBT and gastric scintigraphy; the GEBT results matched the scintigraphy results 73–97% of the time when measured at various time points during the test.

The GEBT is manufactured by Advanced Breath Diagnostics.

For more information visit FDA.gov.

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