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Cairn Diagnostics Nabs Expanded FDA Approval for Breath-Based Gastroparesis Test

NEW YORK ─ Cairn Diagnostics announced Tuesday that the US Food and Drug Administration has expanded the approval of the company's 13C-Spirulina Gastric Emptying Breath Test, or GEBT, to include administration of the test at home under the firm's virtual supervision.

GEBT is an FDA premarket-approved and CE-marked Class III in vitro diagnostic drug-medical device. It measures the rate of solid phase gastric emptying and identifies delayed gastric emptying, a condition known as gastroparesis, in people aged 18 years and older.

Gastroparesis is characterized by abnormally slow emptying of the stomach, which can lead to nausea, vomiting, early satiety, postprandial fullness, abdominal discomfort, and pain.

Cairn said its breath test does not require nuclear medicine imaging equipment, specially licensed facilities or personnel, or radioactive material.

The original premarket approval, granted in 2015, required that the GEBT procedure be supervised by a healthcare professional.

"Our new virtual at-home telehealth administration option significantly expands access to this test, on a more widespread scale, from rural communities to cities," Kerry Bush, president and chief operating officer of Cairn Diagnostics, said in a statement.

According to Cairn's website, the test involves the collection of breath samples before and after a test-related meal. The samples are sent to a central laboratory for analysis by gas isotope ratio mass spectrometry to determine the ratio of 13CO2 to 12CO2 in each sample. By measuring ratio changes over time and comparing them with the pre-meal value, the rate of 13CO2 excretion can be calculated and the individual’s gastric emptying rate determined.

Under the expanded approval, Cairn sends the patient a secure, web-based link for supervised virtual administration of the test. Its certified technologists coach and supervise the patient through the GEBT administration procedure. The breath samples are sent to Cairn’s CLIA-certified lab in Brentwood, Tennessee, and within 48 hours of Cairn receiving the samples, a physician receives a report with test results through a secure portal.