French health-system approves reimbursement of QIAGEN's QuantiFERON latent TB test 
Jun 22 2017

French health-system approves reimbursement of QIAGEN's QuantiFERON latent TB test 

Gold-standard test for latent tuberculosis infection will be covered by national health insurance

Hilden, Germany, and Paris, France, June 22, 2017 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that France’s Ministry of Health and Social Affairs has approved reimbursement by the national health insurance system for QIAGEN’s QuantiFERON-TB® Gold Plus (QFT-Plus®) to screen at-risk individuals for latent tuberculosis (TB) infection.

The French decision to reimburse interferon-gamma release assays (IGRAs) for TB screening includes QIAGEN’s QFT Plus, the leading IGRA test worldwide. QuantiFERON is faster, less labor-intensive and more accurate in screening at-risk populations for latent TB infection than the century-old tuberculin skin test. Previously, QuantiFERON-TB tests have been available in France only if purchased by hospitals or public health centers for health care worker screening or on a non-reimbursed or private-pay basis. After implementation of the new reimbursement code, the health system’s reimbursement for QFT will be approximately 45 euros per test. France joins a growing number of countries in Europe that are reimbursing QFT, including Germany, Greece, Italy, Spain, Switzerland and the UK.

“Adoption of QuantiFERON-TB Gold-Plus by France is a major advance in patient-centered TB screening. Replacing the inaccurate tuberculin skin test with the QFT blood test removes the false-positive results skin tests produce directly due to BCG vaccination, making the QFT-Plus result more accurate and believable to both the provider and the patient. This is key for TB elimination efforts in BCG-vaccinating countries like France, where replacement of the skin test with QFT-Plus will impact key decisions on preventive treatment,” said Dr. Masae Kawamura, Senior Director, TB Medical and Scientific Affairs, at QIAGEN. “France now joins the world’s best TB control programs and academic institutions that use QFT as their assay of choice for patient care and research.”

“The French medical community has advocated for better screening as part of our drive to stop tuberculosis. France has been one of the only countries in Europe where IGRA tests were not reimbursed by public health care insurance. Our country only reimbursed the tuberculin skin test, introduced in 1907, even as clinical studies in recent years showed conclusively that IGRAs are the best diagnostic tools,” said Thierry Bernard, Sr Vice President Head of Business Area Molecular Diagnostics.. “We believe reimbursement is an important step to encourage testing, because France has an estimated 5,000 new cases of active TB per year and nearly 700 deaths. Screening healthcare workers and others populations at risk to progress to active Tuberculosis is essential to eradicating this deadly disease.”

Tuberculosis is a contagious bacterial infection spread primarily through the air, such as by coughing from patients with the active pulmonary form of TB. About 10.4 million new cases of active TB disease and 1.8 million deaths were reported by the World Health Organization for 2015. About one-third of people worldwide have a latent TB infection, in which the bacterium infects a person but does not cause symptoms. About 5-10% of those individuals with latent TB, if untreated, will progress to active disease – so screening and treatment for latent infection play a growing role in global tuberculosis control efforts.

QIAGEN partners with governments and health organizations around the world to fight TB and develop innovative new technologies. As the world’s leading IGRA, QuantiFERON-TB technology has been used in a total of more than 30 million tests so far. QuantiFERON-TB Gold (QFT), the third-generation of the assay, measures immune response to the TB bacterium with antigens to challenge the body’s CD4 T-cells. A positive result indicates infection likely, and guidelines recommend treatment of latent TB to prevent progression to active disease. QuantiFERON-TB® Gold Plus , the fourth generation, builds on this foundation by adding proprietary CD8 antigens to potentially provide more information on the risk of the disease, as well as workflow improvements. QFT-Plus is approved with CE-IVD marking in Europe and has been submitted to the U.S. Food and Drug Administration for use in diagnosing latent TB infection.

To learn more about QFT and QFT-Plus, please visit http://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 (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.

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).

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