Advanced Breath Diagnostics’ Gastroparesis Test Lands FDA Nod

The U.S. Food and Drug Administration (FDA) has approved a diagnostic for a troublesome stomach disorder that is easy to perform and does not use radioactive materials, imaging equipment or specialized interpretation.

The Gastric Emptying Breath Test (GEBT), developed by Advanced Breath Diagnostics, can diagnose gastroparesis, which occurs when muscles in the stomach don’t contract properly, leading to a slowdown or stoppage of the movement of food to the small intestine. The FDA said the disorder can lead to dehydration due to persistent vomiting, as well as malnutrition.

“The GEBT is another option for aiding in the diagnosis of gastroparesis,” Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health in the FDA’s device arm (CDRH), said in a news 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.”

Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine when muscles in the stomach are not contracting properly. It is caused by damage to the vagus nerve that controls the muscles of the stomach and small intestine, often as a result of intestinal surgery, neurological diseases such as Parkinson’s disease and multiple sclerosis, or high blood glucose levels due to diabetes. If left untreated, gastroparesis can lead to problems such as severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in people with diabetes, and malnutrition due to poor absorption of nutrients or a low caloric intake.

After an overnight fast, patients undergoing the test eat a specialized meal containing scrambled eggs and Spirulina platensis, a protein that contains added carbon-13, an isotope of carbon that accounts for just 1% of all naturally occurring carbon. Carbon-12 accounts for the rest.

The GEBT measures the ratio of carbon-12 to carbon-13 at various points in time to determine how quickly the stomach is emptying food, the FDA noted.

The 115-subject clinical trial compared GEBT to gastric scintigraphy, the standard of care for measuring gastric emptying; it requires ingestion of a meal containing radioactive material as well as imaging equipment, and so must be conducted in a specialized outpatient center. The trial found that the breath test results concurred with the results from scintigraphy 73 percent to 97 percent of the time.

The FDA said there were no deaths or serious adverse events during the trial. Some participants experienced nausea or stomach discomfort.

Advanced Breath Diagnostics based in Brentwood, Tenn.