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Qiagen Next-Gen Tuberculosis Test Gets FDA Approval

NEW YORK (360Dx) – Qiagen said today that its QuantiFeron-TB Gold Plus (QFT-Plus) blood test for detecting latent tuberculosis infection has received US Food and Drug Administration approval.

Qiagen submitted the test to FDA in a pre-market approval supplement in late 2016, and the company said that it expects to begin marketing the assay in the US later this year.

QFT-Plus is the fourth-generation version of the test, an immunoassay that detects the release of interferon-gamma as a proxy for latent tuberculosis infection. The US approval follows the 2016 CE-marked launch of QFT-Plus in more than 75 countries across Europe, the Middle East, Africa, Asia, and Latin America, where nearly 2 million of the new tests have already been used, Qiagen said. The prior-generation assay, QuantiFeron-TB Gold, is also CE marked and cleared for use in the US.

The newest generation adds CD8 antigens and workflow improvements that allow for more efficient implementation, especially in large-scale TB screening programs, Qiagen said. These workflow enhancements include single-tube blood collection, as well as an "assay in collection tube" design that allows blood samples to be processed up to 53 hours after venipuncture without affecting the accuracy of the test.

"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," Thierry Bernard, senior VP and head of Qiagen's molecular diagnostics business, said in a statement. "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."