FDA Approves New Test That Helps Diagnose Gastroparesis
Test is less invasive and can be administered in the physician's office
MONDAY, April 6, 2015 (HealthDay News) -- A new breath test (the Gastric Emptying Breath Test [GEBT]) has been approved by the U.S. Food and Drug Administration to aid in the diagnosis of gastroparesis.
Previous tests have been more invasive, involving use of small amounts of radioactive material, the FDA said Monday in a news release. This required that testing be done in a specialized outpatient facility. The GEBT breath test, on the other hand, can be administered in the doctor's office, and is conducted over a four-hour span after an overnight fast. It allows doctors to see how fast the stomach empties solids by measuring carbon dioxide content in a patient's breath, the FDA said.
The new test was compared to an older diagnostic among 115 clinical trial participants. The GEBT test was found to be between 73 and 97 percent accurate, the FDA said, depending on when the measurement was obtained during the four-hour span.
"The GEBT is another option for aiding in the diagnosis of gastroparesis," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement. "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."
The new test is manufactured by Advanced Breath Diagnostics, based in Brentwood, Tenn.