Qiagen NV announced the commercial launch in China of its QuantiFERON-TB Gold In-Tube (QuantiFERON-TB), a blood test that accurately identifies people infected with Mycobacterium tuberculosis, the bacterium that causes tuberculosis (TB). QuantiFERON-TB has become the test of choice around the world and is displacing the century-old tuberculin skin test (TST) in screening for TB infection.
Qiagen already sells QuantiFERON-TB in many markets, including the United States and Europe, and gained approval earlier this year from the China Food and Drug Administration (CFDA). Qiagen announced the QuantiFERON-TB launch to coincide with World TB Day 2014 on March 24.
China has an estimated 1 million reported new cases of active TB each year, more than any country except India, according to the World Health Organization (WHO). Based on the previous survey, an estimated 550 million people in China, 41% of the population, are infected with the TB bacterium. Globally, WHO estimates one-third of the world’s population has latent TB infection.
Left untreated, 5 to 10% of these people will develop active disease during their lifetimes, often when they experience weakened immunity due to other health issues. With the accelerating urbanization in China, the large population with latent TB infection will potentially increase the incidence of TB disease and transmission of the infection. The incidence of multidrug-resistant TB (MDR-TB) and extreme drug resistance TB (XDR-TB), as well as increased co-morbidities such as human immunodeficiency virus (HIV), diabetes and rheumatoid arthritis, make TB control more challenging. In 2012, WHO recommended that an interferon-gamma (IFN-) release assay (IGRA) could be part of clinical evaluation for investigating contacts of persons with infectious tuberculosis in low-and middle-income countries.
Qiagen’s QuantiFERON-TB is the industry-leading IGRA, a modern breakthrough blood test that is faster, more accurate and cost-effective than older methods. QuantiFERON-TB, which measures the body’s cell-mediated immune response to a cocktail of TB-specific antigens, is one of the most studied IGRA and commonly used TB-screening assay in industry and clinical research. Compared with the tuberculin skin test (TST or Mantoux), QuantiFERON-TB is a more precise, easier-to-handle modern alternative. It can reduce false-positive readings caused by the Bacille Calmette-Guérin (BCG) vaccination, which all newborns in countries like China receive as a matter of policy. The TST is notoriously inaccurate in BCG-vaccinated persons because of cross-reacting antigens that commonly cause false positive results.
“We are pleased to announce the launch of QuantiFERON-TB in China, where Qiagen has a major presence, to support TB control efforts. 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,” said Peer Schatz, Qiagen’s chief executive officer. “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 advocates for the ethical usage of QuantiFERON-TB and will target its screening efforts to vulnerable subpopulations including immuno-compromised patients such as those with HIV or diabetes, as well as people with weaker immune systems such as children, the elderly, malnourished, heavy smokers and drug abusers, who have a much higher chance of progressing from latent infection to active TB. In addition, healthcare workers and groups living in congregate settings are more likely to get active TB and pass it on afterwards.
Qiagen is committed to working with experts to encourage research and raise awareness of the disease. Around World TB Day 2014, the company has participated in activities worldwide, including Germany, France, the UK, North America, Philippines, Malaysia, Pakistan and other countries to support the research and development of TB control.
Date: March 20, 2014