Breath Testing is a new technique which offers real benefits for both patient and doctor. A range of tests is available from INFAI for gastrointestinal and metabolic diseases, but all of them have features in common which contribute to their safety, efficacy and convenience. Breath tests use natural metabolic substances (metabolites) labelled with a non-radioactive isotope of carbon. While the metabolite used depends on the disease under investigation, all breath tests measure the rate at which the metabolite is broken down in the body, releasing the labelled carbon first into the blood and very rapidly into the breath. The Figure shows an example of a breath test in which the disease causing stomach bacterium Helicobacter pylori is detected because it breaks down ¹³C-Urea to ammonia and carbon dioxide. In this example an increase in ¹³CO2 in the breath confirms that the patient is infected with Helicobacter pylori and that eradication therapy is indicated.
INFAI is continuing to develop its range of tests, all of which have the following features:
Our policy at INFAI is to thoroughly test our products for efficacy and safety. Although most of the metabolites we use already occur in the body we register them as medicinal products. The licensing process involves extensive clinical evaluation. Our current range of tests is listed below.
Please note that Helicobacter Test INFAI® is a prescription only medicine in the EU and can only be supplied and used by authorised persons. Tests which do not have a current marketing Authorisation may be used in the EU on a named patient basis and for clinical investigation. Please contact your medicines licensing authority if you need to clarify the situation in your own locality.
This ¹³C-Octanoic Acid breath test is used to diagnose delayed gastric emptying of solid food, a condition often associated with diabetes. This test is an alternative to a more invasive radioactive procedure. INFAI has completed clinical trials for this test and is currently applying for an application for a Europe-wide Marketing Authorisation.
This ¹³C-mixed Triglyceride breath test is used to identify pancreatic insufficiency, leading to a problem in digesting and assimilating dietary fat. Pancreolip provides an accurate and alternative means to total stool collection for lipid analysis. This test is also undergoing clinical evaluation prior to licensing.
Pancreoamyl is a second test for pancreatic insufficiency which utilises a naturally occurring compound (corn starch) which contains biologically enriched carbon. A decrease in pancreatic enzyme production results in a decreased ability to metabolise starch and a consequent reduction in the release of naturally occurring ¹³C as carbon dioxide into the breath.
This ¹³C- Sodium Acetate breath test is designed to determine the emptying rate of liquid gastric contents. The efficacy and commercial potential of this test are currently being evaluated with a view to making an application for a Marketing Authorisation in due course.
