QIAGEN's QuantiFERON®-TB Gold Plus gains U.S. FDA approval

Thursday, June 8, 2017 Tropical Disease News
Email Print This Page Comment bookmark
Font : A-A+

Fourth generation Latent TB blood test combines breakthrough CD4/CD8 design for comprehensive immune response detection with the most flexible blood collection workflow

GERMANTOWN, Md. and HILDEN, Germany, June 8, 2017 /PRNewswire/ -- QIAGEN N.V. (NASDAQ:

QGEN) (Frankfurt Prime Standard: QIA) today announced the U.S. regulatory approval of QuantiFERON®-TB Gold Plus (QFT®-Plus) the fourth generation of the market leading blood test for detecting latent tuberculosis (TB) infection.

The approval by the U.S. Food and Drug Administration (FDA) comes after QIAGEN submitted the test in a pre-market approval (PMA) supplement in late 2016, and the U.S. commercialization of the fourth-generation test is planned to begin later this year. 

"We are pleased by the timely FDA approval for QuantiFERON-TB Gold Plus and that we can now bring a range of very attractive clinical and workflow benefits to customers who have helped us to create the market-leading latent TB testing franchise. Tuberculosis is a global disease that is having an impact in the United States as well, where up to 13 million people are infected and nearly 10,000 people are currently suffering with active disease," said Thierry Bernard, Senior Vice President and head of QIAGEN's Molecular Diagnostics Business Area.

The U.S. approval follows the 2016 launch and successful uptake of QFT-Plus in more than 75 countries across Europe, the Middle East, Africa, Asia and Latin America, where nearly two million of the new tests have already been used.

Click here for the full press release

https://www.qiagen.com/about-us/press-releases/pressreleaseview?ID={350B5DA6-3BF6-43E4-91C1-909EEBAF0493}&lang=en

 

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/qiagens-quantiferon-tb-gold-plus-gains-us-fda-approval-300471027.html

SOURCE QIAGEN



Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions

News A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Advertisement
Find a Doctor
Advertisement

Press Release Category

Press Release Archive

Stay Connected

  • Available on the Android Market
  • Available on the App Store

Facebook