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Qiagen Latent TB Test Gets Regulatory Clearance in Japan

NEW YORK (360Dx) – Qiagen said on Thursday that Japan's Ministry of Health, Labor and Welfare has approved QuantiFeron-TB Gold Plus (QFT-Plus) as an in vitro diagnostic to detect tuberculosis infection.

QFT-Plus is the fourth generation of Qiagen's QuantiFeron-TB technology, combining CD4+/CD8+ design for comprehensive immune response detection with a flexible blood collection workflow for efficient screening in large-scale TB control programs, Qiagen said.

"The proprietary CD4+/CD8+ T cell technology of QFT-Plus, with the addition of specific CD8+ T cell stimulating antigens, has the potential to provide important insights for high-risk patients such as contacts exposed to active TB or HIV-positive persons," Masae Kawamura, senior director of TB Medical and Scientific Affairs at Qiagen, said in a statement.

In 2015, the Japanese government set a goal to reduce the country's TB incidence rate to 10 per 100,000 persons by 2020, Kawamura noted. "We are very happy to contribute to achievement of that goal with QFT-Plus becoming an important tool for use in Japan's comprehensive TB control efforts," she said.

QFT-Plus received US Food and Drug Administration approval in June 2017, and Qiagen said the test has seen uptake in more than 75 countries in Europe, the Middle East, Africa, Asia, and Latin America.

In December, Qiagen settled a patent-infringement lawsuit related to its QuantiFeron tests with Oxford Immunotec. In January, Qiagen and DiaSorin announced that they had partnered to offer QuantiFeron tests on DiaSorin's Liaison automated laboratory testing platform.