QIAGEN welcomes WHO’s new global guidelines on latent TB screening
Feb 22 2018

QIAGEN welcomes WHO’s new global guidelines on latent TB screening

World Health Organization recommends scale-up of preventive screening and treatment

Germantown, Maryland, and Hilden, Germany, February 22th, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today endorsed new guidelines issued by the World Health Organization (WHO), which coordinates global efforts to control tuberculosis (TB), calling for harmonization of preventive screening and treatment of latent TB infection among vulnerable groups in countries with a high disease burden, as well as in low-burden countries. The guidelines also acknowledge the clinical value of modern blood tests for latent TB infection, including QIAGEN’s QuantiFERON-TB® Gold Plus.

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. As part of comprehensive programs to eradicate the disease, in recent years the WHO has continued to expand its guidelines for screening high-risk individuals and treating them for LTBI to prevent further contagion.

The new WHO guidelines Latent tuberculosis infection: Updated and consolidated guidelines for programmatic management expand the testing options, the number of groups for testing and treatment options. They remove the prior 2011 recommendation against the use of interferon gamma release assays (IGRAs) in low and middle income countries, where the burden of TB is highest. IGRAs or tuberculin skin test (TST) can now be used for LTBI testing globally. The new guidelines also acknowledge the higher benefit of preventive treatment among persons living with HIV testing positive and the global shortage of TST as a barrier to scaling up LTBI-prevention programs.

The option of IGRA testing increases global equity from prior guidelines that recommended IGRAs only in high- to upper-middle income countries with lower rates of TB. Groups recommended for LTBI testing and preventive treatment have been expanded without country income preference to all persons initiating biologic treatment for autoimmune disease receiving dialysis, or preparing for an organ or hematological transplant, and patients with silicosis. There is also a departure from prior “one size fits all” for high burden settings. It includes a new recommendation for national guidelines to determine the evaluation and treatment of children over the age of five, adolescents and adults who have had household exposure for TB. This provides more options for testing and evaluation of high risk populations previously neglected in high burden settings.

QIAGEN collaborates with international health institutions, non-governmental organizations and commercial partners to support the implementation of WHO guidelines through awareness and educational programs, research and collaborative efforts. QIAGEN’s fourth-generation QuantiFERON-TB Gold Plus and third-generation QuantiFERON-TB® Gold tests are the market-leading modern diagnostic tools for latent TB infection. Known as interferon-gamma release assays (or IGRAs), QuantiFERON-TB tests are faster, less labor-intensive and more accurate than the century-old tuberculin skin test.

“We applaud the World Health Organization’s leadership in their drive to end this global epidemic, expanding screening and prevention to protect populations at risk from latent TB infection progressing to active, contagious disease,” said Dr. Masae Kawamura, Senior Director, TB Medical and Scientific Affairs, at QIAGEN. “The latest WHO guidelines recognize the need for high-burden countries to implement outreach and treatment for the most vulnerable patients with latent TB infection, in addition to treating those with the active disease. We are working closely with public health authorities around the world, as well as supporting efforts to simplify the LTBI screening cascade of care using diagnostic tests and risk-based testing to improve the safety of TB preventive treatment programs.”

Dr. Lee Reichman, M.D., M.P.H., Senior Advisor and Founding Executive Director of the Global Tuberculosis Institute at the Rutgers New Jersey Medical School, added: “Globally, TB control has always correctly focused on active TB, but to defeat this disease requires attacking the reservoir of latent TB infection. The new WHO guidelines acknowledge the importance of laboratory-based IGRA tests in all settings, as well as expanded testing and prevention among high-risk groups. This is definitely a step in the right direction in the global battle to end TB.”

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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