QIAGEN’s QuantiFERON-TB Gold Plus gains approval in Japan
Feb 08 2018

QIAGEN’s QuantiFERON-TB Gold Plus gains approval in Japan

Unique immune detection technology and flexible workflow for tuberculosis control efforts

Hilden, Germany, and Tokyo, Japan, February 8th, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that Japan’s Ministry of Health Labor and Welfare has approved QuantiFERON®-TB Gold Plus (QFT®-Plus) as an in vitro diagnostic to detect tuberculosis (TB) infection. QFT-Plus is the fourth generation of QIAGEN’s market-leading QuantiFERON-TB technology, combining innovative CD4+/CD8+ design for comprehensive immune response detection with the most flexible blood collection workflow for efficient screening in large-scale TB control programs.

“QuantiFERON-TB Gold Plus sets a new global standard for latent TB testing. The proprietary CD4+/CD8+ T cell technology of QFT-Plus, with the addition of specific CD8+T cell stimulating antigens, has the potential to provide important insights for high-risk patients such as contacts exposed to active TB or HIV-positive persons,” said Dr. Masae Kawamura, Senior Director, TB Medical and Scientific Affairs, at QIAGEN. “In 2015, the Japanese government set a goal to reduce the country’s tuberculosis incidence rate to 10.0 per 100,000 persons by 2020. We are very happy to contribute to achievement of that goal with QFT-Plus becoming an important tool for use in Japan’s comprehensive TB control efforts.”

Japan’s approval of QFT-Plus follows 2017 approval in the United States and successful uptake of the test 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. QFT-Plus builds on the foundation of QuantiFERON-TB Gold® (QFT®), the third generation of QIAGEN’s world-leading interferon gamma release assay (IGRA).

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 includes the following new features:

  • Optimized CD8+T cell responses – facilitating 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 patient responses to TB treatment. No other test is optimized for both CD4+ and CD8+ T cell responses.  
  • Expanded blood collection options – enabling customers to take control of the TB testing workflow with blood collection options for flexibility in collection and transport. QFT-Plus offers a new standard single-tube collection option that allows larger volumes 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 QuantiFERON-TB Gold (QFT), the third-generation 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). 

Tuberculosis is a contagious bacterial infection spread primarily through coughing by patients with the active pulmonary form of the disease. In 2016, the World Health Organization (WHO) estimates, there were 10.4 million new cases of active TB worldwide and 1.7 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. Screening of high-risk individuals and treatment for LTBI play an important role in tuberculosis control efforts in 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 (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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