Gen-Probe MTD Labeling Expansion Recommended By Panel With Conditions
This article was originally published in The Gray Sheet
Executive Summary
Gen-Probe should conduct a postmarket study of its MTD amplified mycobacterium tuberculosis direct test "to determine the prevalence" of test usage in suspected tuberculosis patients who are AFB (acid-fast bacilli) smear-negative, FDA's Microbiology Devices Panel recommended May 20 before voting unanimously in favor of FDA expanding the test's indications to include that particular group of patients.