GEN-PROBE GENE AMPLIFICATION TUBERCULOSIS TEST PMA APPROVED BY FDA FOR CONFIRMATION OF POSITIVE AFB STAINS, ALLOWING EARLIER TREATMENT OF TB
This article was originally published in The Gray Sheet
Executive Summary
Gen-Probe plans to submit a premarket approval application supplement for use of its amplified mycobacterium tuberculosis direct (MTD) test on sputum specimens found likely to be TB-negative by acid fast bacilli (AFB) stain, the firm says. FDA approved Gen-Probe's PMA for the gene amplification test on Dec. 18 for use with positive AFB stains only. The company was seeking approval of the MTD test alone and in conjunction with positive and negative stains.