TriMed's H pylori Test Rejected By FDA

4 March 1996

The US Food and Drug Administra-tion has declined to approve a Helicobacter pylori breath test based on the design of the studies submitted in support of the marketing application. The PYtest product was designed by Barry Marshal, the scientist who first linked H pylori infection to the development of peptic ulcer disease.

The application to market the test was made by TriMed of Virginia. The FDA said that the safety of the test was not an issue, but more data on its effectiveness was required. PYtest involves a patient swallowing a mildly-radioactive carbon14 tablet (the radioactivity is similar to that ingested with 15 glasses of orange juice and is far less than a person would be exposed to on an airplane flight). The C14 reacts with the urease enzyme present in patients infected with H pylori and forms C14 carbon dioxide, which can be detec-ted in the breath.

Thomas Burke of the University of Texas, one of the advisory panel convened to consider the application, said that the test is one that is needed and will be useful, but added that without confirmatory evidence he could not vote for approval.

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