QIAGEN Launches QuantiFERON-TB Gold Plus - A New Generation of the Most Accurate Test for Detecting Tuberculosis Infections

GERMANTOWN, Maryland, and HILDEN, Germany, January 7, 2015 /PRNewswire/ --

• QuantiFERON-TB Gold Plus (QFT-Plus) builds on global TB detection leadership anchored by the success of QuantiFERON-TB Gold
• Launch of QFT-Plus CE-IVD version in Europe and other markets comes as QIAGEN achieves milestone with more than $100 million of QuantiFERON-TB sales in 2014
• QFT-Plus to set a new standard in the global fight against tuberculosis

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the CE product launch of QuantiFERON^®-TB Gold Plus (QFT^®-Plus), the fourth generation of the most accurate test for detecting tuberculosis (TB) infections.

QFT-Plus builds on the legacy of QuantiFERON-TB Gold, which was the third-generation version of this important technology that has established itself as a cost-effective tool for TB infection testing with more than 20 million tests distributed worldwide since its initial launch. QFT-Plus, which was recently CE-IVD marked, is now being made available in Europe and other markets and will gradually replace the use of QuantiFERON-TB Gold, which achieved an important milestone with more than $100 million of annual sales in 2014 and becoming one of the largest products within the QIAGEN portfolio.

"The launch of QuantiFERON-TB Gold Plus offers important generational improvements in our industry-leading franchise of diagnostics to detect TB infections, especially as public health experts increasingly recognize the importance of diagnosing and treating latent TB infections in the global fight against this often deadly disease," said Peer M. Schatz, Chief Executive Officer of QIAGEN.

QFT-Plus represents a key milestone in the development of diagnostic tests for latent TB infection. For the first time, a diagnostic test offers the ability to capture a much broader picture of an individual's immune response to TB infection. This technological advancement is critical to advancing the understanding of how the immune system reacts to TB infection, and is expected to set a new standard for future disease management. Among the many new features of QFT-Plus are:

• Improved technology that delivers even higher sensitivity (ability to correctly identify those patients with disease) and specificity (ability to correctly identify all patients without disease) in patients at greatest risk for TB infection, particularly individuals co-infected with HIV/TB and other immunocompromised patients.
• Advances to support research into the risk stratification of latent TB infections developing into active disease based on the first-time incorporation of CD8+ T cell response data, which provides valuable new information to researchers by measuring a broader range of immune response. Published scientific evidence underlines the future potential of CD8+ T cells in distinguishing active from latent TB, discerning recent vs. old infections, detecting TB in certain risk populations (such as HIV co-infection and young children), as well as assessing response to TB treatment.
• Workflow improvements that allow for even more efficient implementation, especially in large-scale TB screening programs. These include a single-tube blood collection option as well as the ongoing use of the unique "assay in collection tube" design that allows for immediate stimulation of the blood sample, which ensures no loss of T cell activity that is critical for obtaining accurate and reliable results.
• Further improvements to test reliability, consistency and performance designed to result in fewer indeterminate results and less requirements for retesting.

The launch of QFT-Plus coincides with the early stages of implementing the Post-2015 Global Tuberculosis Strategy, which was developed by the World Health Organization (WHO) and made public in October 2014. The WHO has outlined a 20-year action plan that includes new guidelines that for the first time addresses latent tuberculosis, including that health authorities in more than 100 low-incidence countries screen for people with latent TB infections and provide preventive treatment for those who are infected. Overall, a global pool of 2 billion people (or 1 in 3 people worldwide) is estimated to be infected with Mycobacterium tuberculosis, and up to 10% of these patients are expected to develop the active form of this airborne and highly contagious disease during their lifetime.

Cost-effectiveness drives QuantiFERON-TB test adoption

Leading TB control programs are turning to QuantiFERON-TB Gold to replace the tuberculin skin test (TST) because this modern test's superior clinical performance and significantly simpler administration improves the cost-effectiveness of TB control programs and overall healthcare. The QuantiFERON-TB Gold technology is faster, laboratory-based and quality-controlled, and more accurate than the century-old TST testing method. The global rollout of QuantiFERON-TB Gold Plus will even further enhance these significant advantages.

Aparticularly costlyissueof TB control programs relying on skin testsis the high rate of false positivesthat lead to unnecessary evaluation and treatment.Recent studies show that 20-85% of positive TST results are negative in BCG-vaccinated persons tested with QFT. False-positive results require follow-up care such as physical examinations, x-rays and laboratory work, even for patients who turn out to have no TB infection - adding unnecessarily to patient risk from unneeded treatment and healthcare expenses. Positive readings provided by QuantiFERON-TB technology, on the other hand, are up to 99% accurate.

Screening with QuantiFERON-TB Gold also reduces false-positive readings caused by common environmental mycobacteria exposure and by the Bacille Calmette-Guérin (BCG) vaccination, which children in many countries receive. The WHO post-2015 strategy supports use of the BCG vaccine in high-burden countries, but the TST is especially inaccurate in BCG-vaccinated persons because of cross-reacting antigens. QuantiFERON-TB Gold does not cross-react with the BCG vaccine,

Building a portfolio on proven QuantiFERON technology

QFT-Plus is the latest product introduction involving the proprietary QuantiFERON® technology, which offers a unique and efficient approach to disease detection. QuantiFERON is able to provide objective information on the activity of cell-mediated functions of the immune system by measuring the release of interferon-gamma in response to specific antigens or proteins contained in whole blood samples through a simple, highly automated process. QuantiFERON is in particular unique in its ability to detect presymptomatic infections that cannot be discovered using standard diagnostic technologies. In addition to the TB infection tests, QIAGEN also offers a CE version of QuantiFERON-CMV, a whole blood assay to monitor changes in cell-mediated immunity to cytomegalovirus (CMV), which is the most common and problematic viral infection in solid organ transplant recipients. Additional assays involving QuantiFERON are in development.

To learn more about QuantiFERON-TB Gold testing technology, please visit http://www.QuantiFERON.com.

Note: This announcement is not for release in the United States, and only for corporate purposes.

About QIAGEN

QIAGEN N.V., a Netherlands-based 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 September 30, 2014, QIAGEN employed approximately 4,200 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 inapplied testing, personalized healthcare, clinical research,proteomics, women's health/HPVtesting andnucleic acid-basedmolecular 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).

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