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TB test submitted for PMA, 3/17

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March 2017—Qiagen announced it submitted its QuantiFeron-TB Gold Plus, the fourth generation of the modern blood test for detecting tuberculosis infection, for premarket approval by the Food and Drug Administration.

The U.S. submission follows the test’s launch in 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 tests have been used, according to a company statement. The QFT-Plus test adds proprietary CD8 antigens and workflow improvements that allow for even more efficient implementation, especially in large-scale TB screening programs.

Qiagen, 240-686-7700

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