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China Approves Qiagen's TB Test for Marketing

NEW YORK (GenomeWeb News) – Qiagen said on Monday that its QuantiFeron-TB Gold test has been approved for marketing in China.

Speaking at Qiagen's analyst day meeting, company officials said that China's State Food and Drug Administration approved the test this month. They added that the company anticipates obtaining a license in early 2014 and launching the test in China shortly afterward.

Qiagen obtained the QuantiFeron testing technology through its purchase of Cellestis in 2011 and has since pushed it as breakthrough technology that could recalibrate tuberculosis testing. The QuantiFeron-TB Gold is a blood-based screening tool for latent TB.

The test was approved by the US Food and Drug Administration in 2005.

In their presentation this week, Qiagen officials highlighted the market opportunity in China for the test, saying China is the world's second-largest market for active TB, and the number of tests in the country is in the tens of millions. They also said that QuantiFeron-TB Gold was used in a large-scale China-based latent TB prevalence study, with results due next year.

Qiagen added that it is developing a fourth generation of the test with better sensitivity in high-risk individuals and improved handling.

QuantiFeron-TB Gold is on track to bring in around $85 million in revenue in 2013, and the firm is targeting sales of more than $100 million for the product in 2014. According to Qiagen, the test is set to become its largest product.