Cairn Diagnostics, an established firm providing cutting-edge breath tests intended for routine use in diagnostic medicine, has announced that the U.S. Food and Drug Administration (FDA) has expanded its approval of the company’s 13C-Spirulina Gastric Emptying Breath Test (GEBT) to now include “at home” administration under the virtual supervision of Cairn Diagnostics.
GEBT
is an FDA-PMA approved, CE marked, Class III in-vitro diagnostic drug-medical
device combination product used for measuring the rate of solid phase gastric
emptying and identifying delayed gastric emptying, a condition known as
gastroparesis, in patients ages 18 years and older. This innovative breath test
is non-invasive, orally administered, and standardized. It does not involve any
radioactive material and does not require nuclear medicine imaging equipment,
specially licensed facilities or personnel.
Conducted
over a 4-hour period after an overnight fast, the GEBT is a simple process, designed
to show how quickly the stomach empties solids by measuring labeled carbon
dioxide in a patient’s breath. The physician receives a comprehensive gastric
emptying report via a secure portal within 24-48 hours after receipt of patient
breath samples.
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Source: GEBT