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QIAGEN’s QuantiFERON®-TB Passes Milestone of 60 Million Tests in Global Fight against Tuberculosis, Current Annual Run Rate Exceeds 12 Million Tests

HILDEN, Germany & GERMANTOWN, Md. & AMSTERDAM--(BUSINESS WIRE)--

New automation options highlighted for QuantiFERON®-TB Gold Plus at ECCMID 2019 to increase efficiency and improve ease of adoption for modern gold standard latent TB test

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its modern gold standard QuantiFERON®-TB test for detection of latent tuberculosis (TB) infections has surpassed 60 million tests administered, having impacted the lives of millions of patients worldwide and supporting the global fight against this public health issue.

QIAGEN is continuing to improve and innovate with new automation options for the fourth-generation QuantiFERON®-TB Gold Plus (QFT®-Plus) test which will continue to drive rapid growth in the conversion of latent TB testing from the century-old technology of tuberculin skin tests to QIAGEN’s modern, accurate and efficient blood test.

The global fight against tuberculosis, the world’s most deadly infectious disease, is a major focus at the 29th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2019), taking place April 13-16 in Amsterdam, Netherlands. Numerous presentations will deal with prevention, diagnosis and treatment of the disease, in its active contagious stage or as a latent infection, in at-risk populations. Four studies focusing specifically on applications of QFT-Plus will be presented at ECCMID 2019.

“As the global community increasingly embraces latent TB screening and treatment to prevent the active disease from spreading, QuantiFERON-TB Gold Plus is the gold standard not only for accuracy but also for cost-efficient, automated workflows. We are proud to achieve the milestone of 60 million QuantiFERON-TB tests, but we are still in the early days of converting from antiquated methods to modern diagnostics,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “This is an exciting time of innovation, commitment and progress toward the shared goal of stopping the global epidemic of tuberculosis.”

QIAGEN continues to enhance the ease of use, efficiency and accessibility of QuantiFERON-TB tests:

  • A read-out kit for QuantiFERON-TB Gold Plus, which was CE-IVD marked in 2018, is rolling out in Europe and other markets as part of DiaSorin’s broad menu of tests for its LIAISON chemiluminescent immunoassay platforms. This efficient automated solution for analysis of QFT-Plus is expected to be available in 2019 in the United States and in 2020 in China. DiaSorin has placed more than 7,000 LIAISON instruments in hospitals and laboratories around the world.
  • QIAGEN is partnering with two leaders in liquid handling solutions to provide options for automated aliquoting of samples from the single tube option to the QuantiFERON-TB Gold Plus Tubes for analysis with the QFT-Plus assay, for those customers who choose to implement a single tube collection process. The collaborations integrate the Hamilton Robotics Microlab® STAR™ automated liquid handling workstation into the QFT-Plus assay workflow, or the Tecan Fluent® Laboratory Automation workstation to automate the manual step of aliquoting of samples from a single collection device such as Lithium Heparin blood collection tube into the QuantiFERON-TB Gold Plus workflow.
  • In partnership with Ellume, a digital diagnostics developer, QIAGEN is developing QuantiFERON®-TB Access (QFT® Access) as a novel workflow dedicated to the needs of low-resource regions with a high disease burden of TB. The global community has an unmet need for a low complexity, highly accurate test for latent TB designed with a focus on cost efficiency and ease of use that brings the best in class QuantiFERON technology to these settings. Clinical trials for QFT Access are planned for this year, and commercialization is expected to begin in 2020.

QIAGEN at ECCMID 2019

Exhibition booth No. 1.20 at ECCMID 2019 will feature demonstrations of QIAGEN’s Sample to Insight solutions for infectious diseases, including QuantiFERON-TB Gold Plus and the company’s QIAstat-Dx, NeuMoDx 288 and 96, and QIAsymphony automation systems. To learn more about QIAGEN’s presence at ECCMID, please visit http://eccmid.qiagen.com or follow the Twitter handle @QIAGEN during the conference.

QuantiFERON-TB Gold Plus combines a flexible new blood collection workflow with innovative CD4/CD8 T cell technology to enable the most comprehensive TB immune response detection available. Now marketed in more than 75 countries, QFT-Plus has been adopted by many organizations such as the International Organization for Migration and the International Panel Physicians Association. More than 20 peer-reviewed publications to date have supported the performance of QFT-Plus, and studies underway in 22 countries involve more than 30,000 patients. For more information, please visit www.quantiferon.com.

Tuberculosis is a contagious bacterial infection spread primarily by coughing of patients with the active pulmonary form of the disease. In 2017, the World Health Organization (WHO) estimates, there were 10 million new cases of active TB worldwide and 1.6 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 four 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 in their lifetimes.

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, 2018, QIAGEN employed about 5,000 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, 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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