QIAGEN to supply QuantiFERON-TB tests to ease tuberculin shortage
German public health authorities turn to modern blood tests amid the influx of refugees
Hilden, Germany, January 26, 2016 – The German Central Committee against Tuberculosis (DZK) recommended that public health services and clinics should use modern blood tests to screen at-risk children for tuberculosis (TB) infection during a shortage of tuberculin, a protein extract used in TB skin tests. The recommendation has been published by the Robert Koch Institute (RKI), the Federal Government’s organization responsible for disease control, in its current “Epidemiologic Bulletin” on January 25th.
According to the RKI, supplies of the only approved tuberculin in Germany are depleted and are causing significant shortages. Unavailability of the traditional skin test is occurring as the significant influx of refugees from Syria and other countries has resulted in an extensive need for TB testing. About 15-20% of the one million migrants, who have received or are seeking asylum in Germany, are estimated to be children below 16 years of age. For this group, current guidelines require screening ̶ using either TB skin tests or interferon-gamma release assays (IGRAs) that allow detection of both latent and active TB infections* from a small blood sample.
The Bulletin cites the proven accuracy of IGRAs. QIAGEN’s QuantiFERON-TB® Gold (QFT®) and QuantiFERON-TB® Gold Plus (QFT-Plus®) are the world’s leading IGRAs, providing highly accurate detection of latent and active TB infection with results in 24 hours. Migrants from regions with high incidence of TB face an elevated risk of latent infections, which – if untreated – can turn active and become contagious and potentially life threatening. The DZK recommends that adult refugees continue to be screened using x-rays, which allow for the detection of active TB infections only.
“QIAGEN stands ready to provide QuantiFERON-TB test kits to make up for the lack of availability of tuberculin for skin tests in Germany”, said Dr. Masae Kawamura, M.D., Senior Director, QuantiFERON Medical and Scientific Affairs at QIAGEN. “The Committee’s recommendation of IGRAs helps to protect public health by continuing to proactively screen children for TB during this shortage. Around the world, QuantiFERON-TB technology has proven its value as an efficient, cost-effective testing solution to aid in TB control efforts. Screening at-risk populations for latent TB infection allows early treatment and prevention of the active disease, which requires aggressive treatment with antibiotics. Expanding the use of IGRAs to cover adults in the current screening regime would therefore help to further reduce the threat of TB infections.”
QIAGEN partners with governments and health organizations around the world to fight tuberculosis – and continues to develop innovative new technologies. QuantiFERON-TB Gold is the modern standard for accuracy in latent TB infection diagnosis – faster, less labor-intensive and more accurate than the tuberculin skin test. QFT’s demonstrated clinical reliability and simpler administration enhance the accuracy of screening and improve the cost-effectiveness of TB control. In 2015 QIAGEN launched QuantiFERON-TB Gold Plus in Europe and other markets as a fourth-generation test with CE-IVD marking. To date, more than 20 million QuantiFERON-TB tests have been distributed globally.
To learn more about QuantiFERON-TB Gold testing technology, please visit www.QuantiFERON.com
*Interferon Gamma Release Assays (IGRAs) cannot distinguish between active and latent TB infections.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions to transform biological materials into valuable molecular insights. QIAGEN sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective molecular testing workflows. QIAGEN provides these workflows to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of September 30, 2015, QIAGEN employed approximately 4,500 people in over 35 locations worldwide. Further information can be found at http://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).