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Breath tests from INFAI

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.

The metabolite used depends on the disease under investigation but 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 a disease causing stomach bacterium (Helicobacter pylori) is detected because it breaks 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.

The Advantages of Breath Tests.

INFAI is continuing to develop its range of tests, all of which have the following features :

Because naturally occurring substances are used the tests are safer than radioactive tests or invasive tests utiliising sedation or anaesthesia.

Breath Tests are accurate and sensitive, often more so than conventional procedures.

The tests are easy to do and there is no discomfort or unpleasant side effects for the patient.

Healthcare costs are significantly reduced when breath tests replace endoscopies and biopsy.

Breath Tests Currently Available from INFAI

Our policy at INFAI is to thoroughly test our products for efficacy and safety and, 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 click the button if you need more information on the test itself or on the licensing status of the medicinal product.

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.

	Helicobacter Test INFAI ^® This test is licensed for supply and use throughout the EU and many other countries. The test is used to diagnose Helicobacter pylori infection of the gastric mucosa which can result in ulcers and some forms of gastric cancer.
	Gastromotal^® 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. Gastromotal^® is currently undergoing clinical trials, prior to licensing.
	Pancreo-Lip^® ¹³C-Mixed Trigyceride breath test is used to identify pancreatic insufficiency leading to a problem in digesting and assimilating dietary fat. Pancreolip^® provides an accurate and alternative to total stool collection for lipid analysis. This test is also undergoing clinical evaluation prior to licensing.
	Pancreoamyl^® 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.
	Gastro-Acet^® ¹³C-Sodium Acetate breath test 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.

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