Cairn Spirulina Breath Test for Gastroparesis

Cairn Gastric Emptying Breath Test

Cairn GEBT: A clear path to diagnosis of gastroparesis

The Cairn 13C-Spirulina Gastric Emptying Breath Test (GEBT) is a non-radioactive, non-invasive, orally administered test for measuring the rate of gastric emptying in adults. Validated against the gold standard reference method of gastric scintigraphy, the Cairn GEBT enables rapid and accurate identification of gastroparesis.

The test can be administered right in the physician’s office and does not require imaging equipment, specialized training or radioactive material. Results are easy to interpret, enabling diagnosis of gastroparesis without the need for expensive, time-consuming referrals.

Cairn GEBT: A faster, more direct path to a definitive diagnosis of gastroparesis

While the Cairn GEBT is simple to administer in any clinical setting, the test meal has been manufactured under highly-controlled drug manufacturing procedures and patient breath samples are analyzed using sophisticated gas isotope ratio mass spectrometry, a U.S. Food and Drug Administration (FDA) approved, validated analytical system.

The test is conducted over a four-hour evaluation period after an eight-hour fast and is designed to show how rapidly the stomach empties solids by measuring carbon dioxide in a patient’s breath. Pre-meal breath samples are collected at the start of the test. Patients then eat a special test meal. After consuming the meal, additional breath samples are collected at specified times. The special meal includes a precisely formulated scrambled egg mix containing pharmaceutical-grade Spirulina, a safe, nutritional blue green algae that, during manufacturing, has been enriched with carbon-13. Once the test meal is consumed, the carbon-13 in the Cairn GEBT test meal gives rise to carbon-13 labeled CO2, or 13CO2, which can be measured in the patient’s breath samples.

Carbon-13 is a naturally existing, safe, non-radioactive form of the common element carbon. Both carbon-12 (naturally abundant in 99% of carbon) and a very small amount of carbon-13 are normally found in exhaled carbon dioxide. By adding carbon-13 to the test meal, the Cairn GEBT can determine how fast the stomach empties the meal by measuring the rate of 13CO2 excretion arising from the digested test meal. The rate of 13CO2 excretion found in the patient’s breath is proportional to the patient’s rate of gastric emptying. The patient’s 13CO2 excretion rate at each breath collection time is reported using the GEBT metric “kPCD.” The “k” is a multiplier of 1000 and “PCD” is an acronym for percent carbon-13 dose excreted (as 13CO2).

Our products are used in the diagnosis of disease and hence are manufactured under strict regulatory controls to assure safety and efficacy as mandated by the United States Food and Drug Administration. The Cairn GEBT is a combination product having both medical device and drug components. Manufacturing activities are conducted in compliance with the Code of Federal Regulations, Title 21 – Food and Drugs. Specifically, manufacturing is conducted consistent with the applicable requirements of 21 CFR Part 4 (cGMP for Combination Products), 21 CFR Parts 210 & 211 (cGMP in Manufacturing, Processing, Packing or Holding of Drugs and Finished Pharmaceuticals) and 21 CFR Part 820 (Quality System Regulation).

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