Cairn Diagnostics has launched the 13-C-Spirulina Gastric Emptying Breath Test for the diagnosis of gastroparesis, according to a press release.
The GEBT measures the rate of solid-phase gastric emptying and is intended to help diagnose delayed gastric emptying in symptomatic adults. Approved by the FDA in April 2015 and validated against gastric scintigraphy, the test is non-radioactive, noninvasive, and allows for fast and accurate diagnosis at a physician’s office, laboratory collection center or tertiary care setting.
The kit includes a test meal containing an egg mixture with pharmaceutical-grade Spirulina platensis enriched with carbon-13 and necessary components for administration. Consuming the carbon-13–enriched test meal gives rise to carbon dioxide-13, and the rate of excretion at any measurement time is proportional to the rate of gastric emptying, according to the press release.
The clinician can collect and send breath samples to the company’s laboratory for FDA-approved, validated gas isotope ratio mass spectrometry analysis, and a comprehensive gastric emptying profile report is then returned to the clinician.
“While scintigraphy has historically been used to confirm the diagnosis of gastroparesis, it requires referral to specialized outpatient centers and exposes patients to radiation,” Kerry Bush, president and chief operating officer of Cairn Diagnostics, said in the press release. “As a result, scintigraphy is frequently used later in the diagnostic pathway, if at all. Diagnosis is challenging because symptomology is a poor predictor of the presence or absence of gastroparesis. Symptoms may be the same for different etiologies of gastroparesis and other conditions such as dyspepsia, GERD and peptic ulcer disease often present with the same constellation of complaints that accompany gastroparesis. This challenging pathway contributes to patients often being treated empirically. However, without confirmation of delayed gastric emptying, clinical outcomes may be uncertain and add additional burden to the patient.”
Disclosure: Bush is employed by Cairn Diagnostics.