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

Montag, 09.01.2017 16:00 von PR Newswire

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.

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QIAGEN contacts:
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John Gilardi     +49-2103-29-11711
Dr. Sarah Fakih  +49-2013-29-11457
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Dr. Thomas Theuringer  +49-2103-29-11826