Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT005235

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel