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In Brief: ChemTrak

This article was originally published in The Tan Sheet

Executive Summary

ChemTrak: Plans to submit 510(k) application to FDA for an OTC H. Pylori test in 1996. The company said it is awaiting completion of multicenter clinical trials involving "a few hundred patients before submitting" a 510(K) for a physician office version of the test later this year. The "one-step" whole blood test can indicate the presence or absence of H. pylori antibodies "in minutes," ChemTrak stated. Astra Merck has U.S. marketing rights to both the professional test and the OTC version under an exclusive agreement with ChemTrak announced in March ("The Tan Sheet" March 6, "In Brief")...
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