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.
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SOURCE QIAGEN