The US Food and Drug Administration (FDA) has granted approval for Advanced Breath Diagnostics’ Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, also known as gastroparesis.
In gastroparesis, malfunctioning stomach muscles stop or slow the movement of food to the small intestine. If left untreated, the condition can cause severe dehydration and blood sugar problems in patients with diabetes and malnutrition.
Tests that are currently available on the market to diagnose gastroparesis depend on radioactive material or imaging equipment, which confine their use to specialised outpatient centres.
The GEBT is conducted over four hours after an overnight fast and it measures carbon dioxide in a patient’s breath to show how fast the stomach empties solids.
FDA Centre for Devices and Radiological Health director of the Office of In Vitro Diagnostics and Radiological Health Alberto Gutierrez said: "The GEBT is another option for aiding in the diagnosis of gastroparesis.
"It can be performed in any clinical setting since it does not require the healthcare professionals administering the test to undergo special training or to take special precautions related to radiation emitting compounds."
According to the FDA, patients have baseline breath tests conducted at the beginning of the test.
After an overnight fast, the patient will be given 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 the common element carbon-12.
At several points in a four-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.
In a clinical trial involving 115 participants, GEBT agreed with gastric scintigraphy, a standard test involving radioactive material, between 73% and 97% of the time.