QIAGEN announced on Thursday that it received approval from the China Food and Drug Administration for its QuantiFERON-TB Gold In-Tube tuberculosis diagnostic blood test.
The test is available in many markets, including the United States and Europe, and has become the test of choice, replacing the tuberculin skin test that was used for centuries.
China has approximately one million new tuberculosis cases each year, second only to India, according to the World Health Organization.
Because of increasing urbanization in China, persons unknowingly infected with TB could increase the transmission and incidence of the disease. WHO said the occurrence of multidrug-resistant TB and increased human immunodeficiency virus, diabetes and rheumatoid arthritis make controlling TB more difficult.
"We are pleased to announce the launch of QuantiFERON-TB in China, where QIAGEN has a major presence, to support TB control efforts," QIAGEN CEO Peer Schatz said. "Use of QuantiFERON-TB to screen vulnerable populations is growing rapidly in the United States, Europe and other markets, and we are focusing on this important product as one of QIAGEN's global growth drivers. The superiority of QIAGEN's QuantiFERON technology to deliver more reliable results than the 120-year-old tuberculin skin test already is well accepted among physicians in China, paving the way for the entry of QuantiFERON-TB into this important market."
QIAGEN said it would target screening efforts to subpopulations including patients with compromised immune systems such as HIV or diabetes, children, elderly, malnourished, heavy smokers and drug abusers.