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Qiagen N.V.. (6/8/17). "Press Release: Qiagen’s QuantiFERON-TB Gold Plus Gains U.S. FDA Approval". Germantown, MD & Hilden.

Region Region United States (USA)
Organisations Organisation Qiagen GmbH
  Group Qiagen (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product QuantiFERON®-TB Gold Plus test (QFT-Plus®)
  Product 2 molecular diagnostics
Person Person Bernard, Thierry (Qiagen 201502– SVP Molecular Dx business area before bioMérieux Corp VP Commcercial Operations)
     


Fourth generation Latent TB blood test combines breakthrough CD4/CD8 design for comprehensive immune response detection with the most flexible blood collection workflow


QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. regulatory approval of QuantiFERON®-TB Gold Plus (QFT®-Plus) the fourth generation of the market leading blood test for detecting latent tuberculosis (TB) infection.

The approval by the U.S. Food and Drug Administration (FDA) comes after QIAGEN submitted the test in a pre-market approval (PMA) supplement in late 2016, and the U.S. commercialization of the fourth-generation test is planned to begin later this year.

“We are pleased by the timely FDA approval for QuantiFERON-TB Gold Plus and that we can now bring a range of very attractive clinical and workflow benefits to customers who have helped us to create the market-leading latent TB testing franchise. Tuberculosis is a global disease that is having an impact in the United States as well, where up to 13 million people are infected and nearly 10,000 people are currently suffering with active disease,” said Thierry Bernard, Senior Vice President and head of QIAGEN’s Molecular Diagnostics Business Area.

The U.S. approval follows the 2016 launch and successful uptake of QFT-Plus 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.

With the addition of proprietary CD8+ technology, QFT-Plus represents a key milestone in the development of diagnostic tests for latent TB infection. For the first time, a test has the potential to offer the ability to capture a much broader picture of an individual's immune response to TB infection. This technological advancement is critical to improving 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:

> 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 flexibility that allows for even more efficient implementation, especially in large-scale TB screening programs. These include a standard single-tube blood collection option which allows blood samples to be processed up to 53 hours after venipuncture without affecting the accuracy of the test. This adds to the existing, unique "assay in collection tube" design allowing for immediate stimulation of the blood sample.


QFT-Plus builds on the foundation of QuantiFERON-TB Gold® (QFT®), the third-generation version of the world’s leading interferon gamma release assay (IGRA). QFT is well proven, with a vast body of clinical evidence, as a cost-effective and efficient tool for TB infection testing.

QFT-Plus is set to be commercialized amid new recommendations that are broadening the use of IGRAs in the U.S. In December 2016, a task force supported by the American Thoracic Society (ATS), U.S. Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America published new evidence-based guidelines recommending the use of IGRA tests in wider groups of people at risk for TB infection. This followed recommendations by the U.S. Preventive Services Task Force (USPSTF) in September 2016 that primary care physicians should screen adult patients in groups at high risk for latent TB infection. Both referred to QFT as an FDA-approved IGRA at the time, preferable in certain patient groups to the century-old tuberculin skin test (TST).

Nine independent peer-reviewed publications to date have supported the performance of QFT-Plus, and additional studies underway in 22 countries involve more than 30,000 patients. The first research studies include comparisons on sensitivity in active TB and close contacts, as well as on laboratory precision and correlation to flow cytometry. QFT-Plus is the only IGRA TB test on the pathway to evaluation by the World Health Organization (WHO) as part of its global campaign to eradicate the disease.

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 March 31, 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).

   
Record changed: 2017-06-16

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