FDA Approves Gastroparesis Test for Any Clinical Setting

Disclosures

April 06, 2015

Any physician can now diagnose gastroparesis in his or her office, thanks to a new breath test approved today by the US Food and Drug Administration (FDA).

In gastroparesis, malfunctioning stomach muscles stop or slow the movement of food to the small intestine. Left untreated, the condition can cause severe dehydration, blood sugar problems in patients with diabetes, and malnutrition.

Tests now on the market to diagnose gastroparesis typically rely on radioactive material or imaging equipment, which confine their use to specialized outpatient centers, the FDA said in a news release. The gastric emptying breath test (GEBT) from Advanced Breath Diagnostics can be used in any clinical setting because it does not require special training for healthcare professionals or special precautions dictated by radioactive compounds.

The GEBT shows how fast the stomach empties solid food by measuring carbon dioxide in a patient's breath. After an overnight fast, the patient eats a special test meal that includes a scrambled-egg mix and the protein spirulina platensis, which has been enriched with carbon-13, a naturally existing nonradioactive form of carbon-12. Exhaled carbon dioxide contains both kinds of carbon. At multiple points in a 4-hour period after the test meal, GEBT calculates the rate of stomach evacuation by measuring the ratio of carbon-13 to carbon-12 in breath samples. That gets compared with a baseline ratio calculated before the meal.

In a clinical trial, GEBT agreed with gastric scintigraphy, a standard test involving radioactive material, between 73% and 97% of the time. Some patients experienced nausea and stomach discomfort with GEBT, but no serious adverse events were reported.

The FDA cautions that individuals with hypersensitivity to spirulina, egg, milk or wheat allergens should avoid GEBT. In addition, clinicians should not administer it to patients with certain lung diseases or conditions that trigger small-bowel malabsorption.

More information on today's announcement is available on the FDA website.

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