QIAGEN welcomes WHO’s Essential Diagnostics List which includes QuantiFERON-TB Gold
May 22 2018

QIAGEN welcomes WHO’s Essential Diagnostics List which includes QuantiFERON-TB Gold

The World Health Organization recommends IGRA tests in the First Edition of Essential In Vitro Diagnostics

Germantown, Maryland, and Hilden, Germany, May 22, 2018 – QIAGEN today welcomed the First Edition of the World Health Organization’s (WHO) Essential Diagnostics List, which endorses the use of interferon gamma release assays (IGRAs) for the diagnosis of latent TB infection. The inclusion on the list comes as the WHO and other organizations like the US Centers for Disease Control (CDC), the International Panel Physicians Association (IPPA) and others have recommended to include IGRA’s such as QuantiFERON-TB Gold Plus.

The World Health Organization (WHO) published the first edition of the Model List of Essential In Vitro Diagnostics (EDL) in May 2018, in recognition that IVDs are an essential component to advance universal health coverage, address health emergencies, and promote healthier populations. The EDL outlines 113 IVDs that are recommended by WHO for use at various levels of a tiered national health care system.

Tuberculosis is a contagious bacterial infection spread primarily through coughing by patients with the active pulmonary form of the disease. In 2016, there were 10.4 million new cases of active TB worldwide and 1.7 million deaths from TB, according to WHO estimates. In latent tuberculosis infection (LTBI), the bacterium infects a person but produces no symptoms unless it progresses to active disease, at which stage the patient is highly contagious. As part of comprehensive programs to eradicate the disease, the WHO has recently issued and expanded its guidelines for screening high-risk individuals and treating them for LTBI as an effective tool to prevent further contagion and reduce the disease burden.

QuantiFERON-TB Gold (QFT) is one of two recommended tests in the WHO guidelines as an alternative to tuberculin skin tests. The latest generation of QFT is QFT-Plus and is available in more than 75 countries in Europe, the Americas, Africa, Asia and Middle East. QFT-Plus, first introduced in 2015, builds on the foundation of QIAGEN’s QuantiFERON-TB Gold (QFT). QFT-Plus advances the science of TB testing with innovative antigens that measure the cell-mediated immune response to tuberculosis infection from both CD4+ and CD8+ T cells. The addition of CD8+ assessment has led WHO in its Global TB Report 2016 to cite QFT-Plus (the only such test on the market) for its potential in identifying at-risk adults at greater risk of progressing to active TB.

To learn more about QFT-Plus, QFT and tuberculosis control, please visit www.quantiferon.com.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our 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 workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of December 31, 2017, QIAGEN employed approximately 4,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Certain statements contained in this press 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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected sales, adjusted net sales and adjusted diluted earnings per share 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 to customers in academia, pharma, applied testing and 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 and the integration of acquired technologies and businesses; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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).

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