FDA OKs Delayed Gastric Emptying Diagnostic Breath Test

The FDA on Monday approved the Gastric Emptying Breath Test, a noninvasive diagnostic for delayed gastric emptying, also known as gastroparesis, developed by the Brentwood, Tenn.-based Advanced Breath Diagnostics.

Existing gastroparesis tests usually involve a small amount of radioactive material or imaging equipment, meaning testing is confined to outpatient centers where health professionals must have specialized training or take special precautions. By comparison, the GEBT can be conducted in any clinical setting, the FDA says.

Administered over a four-hour interval following an overnight fast, the GEBT reveals the rate the stomach empties solids by measuring specific carbon dioxide isotopes in an individual’s breath. Patients are given a baseline breath test, and then eat a test meal containing a scrambled egg-mix and a special protein, spirulina platensis, enriched with carbon-13.

An FDA clinical study of 115 gastroparesis patients demonstrated that when treated with the GEBT, diagnostic results aligned with gastric scintigraphy, the standard of care featuring radioactive material ingestion, 73 percent to 97 percent of the time.

Gastroparesis is a disorder that slows or stops food movement from the stomach to the small intestine because stomach muscles do not contract correctly. The disorder is caused by damage to the vagus nerve, which controls stomach and small intestine muscles, usually caused by intestinal surgery, neurological diseases or high glucose blood levels from diabetes.

Left untreated, gastroparesis can lead to severe dehydration due to chronic vomiting, difficulty managing blood sugar levels in diabetics, and malnutrition caused by poor nutrient absorption or a low caloric intake.

The GEBT should not be administered to patients suffering from certain lung diseases or those with disorders that cause small bowel malabsorption. — Jason Scott