QIAGEN launches QuantiFERON-TB Gold In-Tube in China to aid tuberculosis control in country with the second-largest TB burden
- QuantiFERON-TB, the leading modern test for accurate diagnosis of latent tuberculosis infections, continues to grow rapidly around the world
- Commercial launch of QuantiFERON-TB in China, where latent TB affects an estimated 41% of population, will support nationwide efforts to control TB
- QIAGEN marks World TB Day 2014 on March 24 with QuantiFERON-TB launch in China and activities in other regions
Beijing, China, and Hilden, Germany, March 20, 2014 — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the commercial launch in China of its QuantiFERON®-TB Gold In-Tube (QuantiFERON-TB), the pioneering 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 U.S. 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, Monday 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-g) 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.
To learn more about QuantiFERON-TB Gold In-Tube, please visit:
To learn more about QIAGEN’s initiatives on the World TB Day 2014, please visit:
QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of December 31, 2013, QIAGEN employed approximately 4,000 people in more than 35 locations worldwide. Further information can be found at www.QIAGEN.com/.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in applied testing, personalized healthcare, clinical research, proteomics, women's health/HPV testing and nucleic acid-based molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).