QuantiFERON-TB Gold Plus filed with FDA as test for tuberculosis- Qiagen

QIAGEN has 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 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.