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QIAGEN Submits QuantiFERON®-TB Gold Plus for U.S. Regulatory Approval

Montag, 09.01.2017 16:00 von

PR Newswire

GERMANTOWN, Maryland and HILDEN, Germany, January 9, 2017 /PRNewswire/ --

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the submission of QuantiFERON®-TB Gold Plus (QFT®-Plus), the fourth generation of the modern blood test for detecting tuberculosis (TB) infection, for pre-market approval (PMA) by the U.S. Food and Drug Administration (FDA).

The U.S. submission follows the launch during 2016 and positive uptake of QuantiFERON-TB Gold Plus in more than 60 countries across Europe, the Middle East, Africa, Asia and Latin America, where more than 600,000 of the new tests have already been used.

QFT-Plus builds on the foundation of QuantiFERON-TB Gold® (QFT®), the third-generation version of the world's leading interferon gamma release assay (IGRA), which has been established as a cost-effective and efficient tool for TB infection testing with more than 30 million tests conducted worldwide since its initial launch. The fourth-generation QFT-Plus test adds proprietary CD8 antigens and workflow improvements that allow for even more efficient implementation, especially in large-scale TB screening programs. These include a single-tube blood collection option, as well as the current use of the unique "assay in collection tube" design that allows for immediate stimulation of the blood sample.

Click here for full press release

https://www.qiagen.com/about-us/press-releases/pressreleaseview?ID={128CDBC1-6FFD-49DE-BEFC-5327DC7BFD67}&lang=en

QIAGEN contacts:
Investor Relations    
John Gilardi     +49-2103-29-11711
Dr. Sarah Fakih  +49-2013-29-11457
e-mail: ir@QIAGEN.com     
   
Public Relations    
Dr. Thomas Theuringer  +49-2103-29-11826        
e-mail: pr@QIAGEN.com


SOURCE QIAGEN N.V.