Gen-Probe gene amplification TB test passes panel muster.
This article was originally published in The Gray Sheet
Executive SummaryGEN-PROBE'S GENE AMPLIFICATION TUBERCULOSIS TEST IS APPROVABLE for use in conjunction with an acid fast bacilli (AFB) smear to aid in the initial diagnosis of tuberculosis for select patient groups, FDA's Microbiology Panel agreed in a 7-3 vote at a May 2 meeting in Gaithersburg, Maryland. Conditions placed on the panel's approval recommendation for the amplified mycobacterium tuberculosis direct (MTD) test include premarket approval application data revisions and further studies.
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