The ¹³C-Spirulina Gastric Emptying Breath Test (GEBT) is the First and Only FDA-Approved, ACG and AGA Guideline Recommended Breath Test For Diagnosing Gastroparesis
Cairn Diagnostics developed the ¹³C-Spirulina Gastric Emptying Breath Test (GEBT) to evaluate the rate of solid phase gastric emptying and aid in diagnosing gastroparesis.
The GEBT is a safe, standardized, non-radioactive and FDA-approved alternative to nuclear medicine-based gastric emptying evaluations.
The GEBT is administered via Cairn Diagnostics virtual telehealth program. Because it does not require nuclear imaging, the GEBT is much more accessible for patients.
Always a 4-hour evaluation.
We have spent years developing GEBT to ensure accurate and standardized results. The GEBT has been validated against 4-hour scintigraphy.
Over 15,000 GEBTs analyzed in our CLIA-certified lab.
Our CLIA-certified lab ensures the accuracy, reliability, and timeliness of patient test results.
A NEW, MORE DIRECT PATH TO DIAGNOSIS
The Cairn ¹³C-Spirulina Gastric Emptying Breath Test (GEBT) is the only FDA-approved breath test to aid in the definitive diagnosis of gastroparesis. Because it does not require imaging equipment, specialized training in radiation safety and handling radioactive materials, the Cairn GEBT can be administered in a patient’s home under virtually supervised telehealth. Validated against the method of 4-hour gastric scintigraphy, the test enables rapid and accurate identification of gastroparesis by avoiding the need for expensive, time-consuming referrals to nuclear medicine centers.
GEBT provides a non-radioactive alternative to gastric scintigraphy.
Patient Breath samples are analyzed in our CLIA-certified lab.
Learn more about FDA-Approved interpretive guidelines for the GEBT here.
Frequently Asked Questions
When is the GEBT used?
The ¹³C-Spirulina Gastric Emptying Breath Test (GEBT), to be used with the GEBT test meal, is intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
The GEBT procedure should be administered under supervision of a health care professional although no specialized facilities or specially licensed personnel are required.
When should the GEBT not be used?
People with hypersensitivity to Spirulina, egg, milk or wheat allergens should avoid the GEBT. The GEBT should not be administered to people with certain lung diseases or conditions that cause small bowel malabsorption. For additional warnings and precautions please see the GEBT product labeling.
How do I get this test for my patients?
Fill out the Telehealth Order Form and fax to (615)-376-6384. For questions, email telehealth@cairndx.com. Please attach patient’s insurance card, front and back.
How is the test administered?
The Cairn GEBT is administered in a patient’s home under virtually supervised telehealth. Our team of administrators will call and schedule the administration upon receiving an order.
Learn more about the process here.
How does the test work?
After an overnight fast and collection of an initial (baseline) breath sample, the patient eats a powdered scrambled egg meal containing a nutritional algae material, Spirulina.
The algae is labeled (grown) with a safe, rare, non-radioactive form of carbon, known as Carbon-13.
After the patient eats the ¹³C-Spirulina/egg test meal, the meal is emptied and metabolized, which causes an increase of Carbon-13 labeled carbon dioxide (“13CO2”) molecules in the breath.
The rate of excretion of the ¹³CO2 in the breath at different collection timepoints is directly proportional to the rate of gastric emptying.
We measure the rate of gastric emptying at 6 individual timepoints during the 4-hour evaluation period.
Scintigraphy uses 4 measurements at best, and most often only 2 measurements over 2 hours.
What is in the test meal?
The test meal is composed of 27 grams of scrambled egg mix containing 100 mg of Carbon-13 Spirulina (roughly equivalent to 2 scrambled eggs), 6 Saltine Crackers and 6 ounces of water.
Nutritional Information
Ingredients (scrambled egg): Desugared whole eggs, Dry non-fat milk solids, Salt, Smoke Flavoring (Char Oil), ¹³C-labeled Spirulina.
Ingredients (saltine crackers): Unbleached enriched flour (wheat flour, niacin, reduced iron, thiamine mononitrate {vitamin b1}, riboflavin {vitamin b2}, folic acid), soybean and/or canola oil, palm oil, sea salt, salt, malted barley flour, baking soda, yeast. Contains: wheat.
Meal Nutritional/Energy Values Fat 9.8g, Carb 18g, Fiber 0g, Protein 13g, Sodium 636mg. 230kCal
How accurate is the test?
Cairn’s ¹³C-Spirulina Gastric Emptying Breath Test (GEBT) was rigorously validated against the traditional 4‑hour gastric emptying scan, long considered the clinical standard but often performed inconsistently in practice, and delivers an accurate, standardized, and patient‑friendly solution that overcomes many of scintigraphy’s limitations.
Comprehensive proof‑of‑principle studies, establishment of normal reference ranges, and pivotal validation trials were conducted at leading academic centers, including Vanderbilt University, Northwestern University, and Mayo Clinic. The GEBT consistently demonstrated excellent analytical and diagnostic agreement with 4‑hour Gastric Emptying Scintigraphy (GES).
· High specificity at key time points: 93.3% (45 min), 96.9% (90 min), 98.3% (120 min), 96.8% (150 min).
· Strong diagnostic concordance: 87.0% (45 min), 80.9% (90 min), 76.5% (120 min).
· Biologic variability similar between GEBT and scintigraphy across normal and marginally delayed subjects.
How do I interpret the GEBT?
Please see our interpretive guidelines here.
How much does this test cost?
The GEBT is covered by Medicare and most commercial payors.
Please see our billing procedures.
Cairn Diagnostics offers Hardship and Income-Based payment plans to best serve our patient’s needs.
How was the GEBT validated and approved for use in patients?
Researchers conducted an FDA-approved safety and effectiveness study at the Mayo Clinic using data from 115 participants representing the intended use population. Each subject underwent simultaneous evaluation by GEBT and Gastric Scintigraphy (GS).
GEBT was validated against the method of GS because GS has been considered in the medical community to be the gold standard for diagnosing gastroparesis. GS requires consuming a test meal containing a radioactive material. Researchers compared the results from both the GEBT and GS and found that GEBT results agreed with scintigraphy results 73-97 percent of the time when measured at various time points during the test procedure.
GEBT results should be used together with a patient’s medical history to diagnose gastroparesis and determine treatment options. The GEBT is a Class III PMA-approved medical device (combination product) regulated by the United States Food and Drug Administration.
Is there FDA Guidance on using the GEBT in clinical studies?
Yes. Guidance for use of GEBT in clinical studies evaluating drugs for gastroparesis is published in FDA Guidance “Gastroparesis: Clinical Evaluation of Drugs for Treatment, Guidance for Industry”, July 2015.
Although Gastric Scintigraphy (GS) has been considered in the medical community to be the gold standard for diagnosing gastroparesis, FDA notes that “qualified personnel are needed to conduct this test, and scintigraphy induces a significant radiation burden (Siegel, Wu, et al. 1983), which may limit its application in children, fertile women, and subjects undergoing repetitive measurements of gastric emptying in a short period of time.
The advantages and disadvantages of each approach (GS or GEBT) should be considered when designing a clinical trial in gastroparesis and when identifying the appropriate patient population for study.”
Learn more about the GEBT and how it provides a more complete work-up for your patients. Fill out the form below to order your test today.
For existing accounts, please click here to order GEBT by Telehealth.
PROVEN
Validated, Standardized, FDA approved and Clinical Guideline recommended.
SAFE
Non-invasive with no exposure to radioactive materials.
TRUSTED
4-hour, comprehensive evaluation.
Our lab is CLIA-certified.
CONVENIENT
Cairn Diagnostics will adminster the test from scheduling to reporting.