logo
  Join        Login             Stock Quote

FDA Proposes To Downclassify Certain TB Tests For Improving Diagnosis

 March 17, 2012 06:56 PM


The U.S. health regulators plan to downclassify certain tuberculosis (TB) tests, a move that should boost the development of TB diagnostics.

The U.S. Food and Drug Administration (FDA) propose to lower the current risk classification for nucleic acid-based tests to Class II (moderate-risk) from Class III (high-risk), which the agency says requires the more rigorous pre-market approval application.

According to the agency, nucleic acid-based tests detect the genetic material of infecting bacteria, helping in timely detection of TB disease. When used along with other clinical tests, these tests can result in improved patient results and stop further spread of TB.

TB is caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain. TB is spread through the air from one person to another. If not treated properly, TB disease can be fatal.

[Related -ADP: US February Payrolls Continue To Grow, But At Slower Rate]

According to the Centers for Disease Control and Prevention (CDC), one third of the world's population are infected with TB. Around nine million people around the world became sick with TB.  Common symptoms of TB disease include: a bad cough that lasts three weeks or more, pain in the chest, coughing up blood or sputum, weakness or fatigue, and weight loss.

The CDC recommends health care providers perform nucleic acid testing on at least one sample of mucus coughed up from the lower airways (sputum) from patients with signs and symptoms of TB disease, when the test result would alter patient treatment. The FDA's new proposal will support CDC recommendations.

[Related -Are You Prepared For Negative Interest Rates?]

General controls alone are not sufficient to assure safety and effectiveness of Class II and Class III tests. Class II devices are also subject to special labeling, mandatory performance standards, and post-market surveillance, according to the FDA.

The FDA believes it can still address the safety and effectiveness of the nucleic acid-based diagnostics for TB through its draft guidance, which identifies the risks related to false positive and false negative test results as well as recommends on how to mitigate those risks.

iOnTheMarket Premium
Advertisement

Advertisement


Post Comment -- Login is required to post message
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
 

rss feed

Latest Stories

article imageADP: US February Payrolls Continue To Grow, But At Slower Rate

Payrolls at US companies posted another respectable gain in February, advancing 212,000 over the previous read on...

article imageAre You Prepared For Negative Interest Rates?

Last Tuesday, all eyes were on Federal Reserve Chief Janet Yellen. In prepared testimony, she offered a few read on...

article imageGreek Problems Born from Socialism

Our weekly commentaries provide Euro Pacific Capital's latest thinking on developments in the global read on...

article imageThe Eurozone: On The Road To Recovery With A Lingering Risk

Back in September the idea that the Eurozone's economy could potentially undergo a recovery (see post) was read on...

Advertisement
Popular Articles

Advertisement
Daily Sector Scan
Partner Center

Related Articles:

Greek Problems Born from Socialism
More Articles on: Finance



Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.