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Meretek's UBT urea breath test 95% accurate in detection of H. pylori, study shows.

This article was originally published in The Gray Sheet

Executive Summary

MERETEK'S UBT UREA BREATH TEST 95% ACCURATE IN DETECTION OF H. PYLORI, according to a study by David Graham, MD, MACG, Baylor College of Medicine, Houston, et al., published in the April issue of the American Journal of Gastroenterology. The study concludes that the noninvasive Carbon-13 urea breath test "has the potential to be an important tool both in the diagnosis of infection and in patient management after antimicrobial therapy." A combination 510(k)/new drug application for the test kit, submitted in May 1995, is pending at FDA.
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