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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

"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."

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.

See Also:

"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."

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.