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FDA approves newest blood test to detect latent TB

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QIAGEN N.V. received FDA approval for the use of QuantiFERON-TB Gold Plus, the newest generation of the market-leading blood test for detecting latent tuberculosis, in the U.S., according to a press release.

This fourth-generation latent tuberculosis blood test offers new benefits for infection control, combining CD4 and CD8 technology, to enable comprehensive immune response detection, with flexible blood collection workflow, to allow for more efficient implementation. This will improve the understanding of how the immune system reacts to TB and will set a new standard for disease management.

Building on the foundation of the third-generation leading interferon gamma release assay (IGRA) version, QuantiFERON-TB Gold Plus (QTF-Plus) will incorporate CD8+ T cell response data to better detect latent TB infection before it develops into active disease. To date, nine independent peer-review publications have supported the performance of QTF-Plus, the only IGRA TB test on the pathway to evaluation by WHO as part of its global campaign to eradicate TB.

The approval for use in the U.S. comes after the 2016 launch and successful uptake of QFT-Plus in more than 75 countries globally. QFT-Plus will be commercialized later this year in response to new evidence-based guidelines supported by the American Thoracic Society (ATS), CDC and Infectious Disease Society of America (IDSA) that are broadening the use of IGRAs for people at risk of TB infection.

“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,” Thierry Bernard, Senior Vice President and head of QIAGEN’s molecular diagnostics business area, said in the release. “We are pleased ... 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.”

Disclosures: Bernard is a Senior Vice President at QIAGEN.