QIAGEN launches fourth-generation QuantiFERON®-TB Gold Plus in the U.S.

Germantown, Maryland, and Hilden, Germany, October 5, 2017 – QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of QuantiFERON®-TB Gold Plus (QFT®-Plus), the fourth generation of its leading blood test for tuberculosis (TB) infection. QFT-Plus kits will be available on October 9, 2017 for diagnostic use following U.S. Food and Drug Administration approval in June.

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 – providing a broader assessment of TB infection. CD8+ T cells have been shown to play an important role in Mycobacterium tuberculosis immunity.  

QFT-Plus builds on the foundation of QuantiFERON-TB Gold® (QFT®), the third generation of QIAGEN’s world-leading interferon gamma release assay (IGRA). The new QFT-Plus test includes the following new features:

  • Optimized CD8 T cell responses — Facilitates research on patient risk stratification of latent TB infections developing into active disease. Published evidence underlines the future potential of CD8+ T cells for distinguishing active from latent TB, discerning recent vs. old infections, detecting TB in certain populations such as HIV co-infection and young children, as well as assessing one’s response to TB treatment. No other test is optimized for both CD4 and CD8 T cell responses.  
  • Expanded blood collection options — Collection and transport flexibility that enables customers to take control of the TB testing workflow with several blood collection options. QFT-Plus offers a new standard single-tube blood collection option that allows larger volume labs or remotely collected blood samples to be processed up to 53 hours after venipuncture for flexible transport to the lab. The existing “assay in collection tube” design for immediate stimulation of the blood sample continues to provide a direct draw option with the identical transport times as the previous QuantiFERON 3rdgeneration assay.
  • High sensitivity and specificity — QFT-Plus has a specificity of >97% and a sensitivity of >94%, producing more accurate results than the century-old tuberculin skin test (TST).

“QuantiFERON-TB Gold Plus sets a new benchmark in TB testing with the addition of specific CD8+ T cell stimulating antigens. Many clinicians have already realized the patient-centered aspects of a single visit to get a result and accuracy of laboratory testing over the tuberculin skin test. The proprietary CD4+/CD8+ T cell technology of QFT-Plus has the potential to provide important insights for high-risk patients such as contacts exposed to active TB or HIV-positive persons while maintaining high specificity,” said Dr. Masae Kawamura, Senior Director, TB Medical and Scientific Affairs, at QIAGEN. “In the United States, test accuracy has never been more important as the country aggressively fights to end tuberculosis through recent policy-driven expansion of targeted testing and preventive treatment. It is currently estimated that 93% of the TB disease in the U.S. comes from the 13 million-person reservoir of latent TB infection.”

The U.S. introduction of QFT-Plus follows adoption in more than 75 countries across Europe, the Middle East, Africa, Asia and Latin America, where nearly two million of the new tests have already been used. More than ten peer-reviewed publications to date have supported the performance of QFT-Plus, and studies underway in 22 countries involve more than 30,000 patients. QFT-Plus is the only IGRA test on the pathway to evaluation by the World Health Organization (WHO) for its global campaign to eradicate TB.

Tuberculosis is a contagious bacterial infection spread primarily by coughing of patients with the active pulmonary form of the disease. In 2015, WHO estimates, there were 10.4 million new cases of active TB worldwide and 1.8 million deaths from TB. In latent tuberculosis infection (LTBI), the bacterium infects a person but produces no symptoms unless it progresses to the active disease. On a global basis, approximately one out of three people are estimated to have latent TB infection, and about 5-10% of those individuals, if untreated, will progress to active tuberculosis at some point. Screening of high-risk individuals and treatment for LTBI play an important role in tuberculosis control efforts in the U.S. and many European countries, as well as in other developed and emerging markets around the world.

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 (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of June 30, 2017, QIAGEN employed approximately 4,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

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, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings 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. 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).