QIAGEN N.V.: QIAGEN Launches Novel QIAreach QuantiFERON-TB Tuberculosis Test for High-Burden Regions

• QIAGEN leverages QuantiFERON-TB technology to advance global efforts against TB
• TB IGRA testing now accessible in high burden, low resource and decentralized settings
• Study data also showcased at the Union World Conference show promising results

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch and CE marking of QIAreach QuantiFERON-TB test for tuberculosis (TB) infection, in order to help achieve global TB elimination targets by increasing access to easy and reliable TB testing, especially in high burden countries, low-resource regions.

A milestone in the fight against a pathogen estimated to be carried by over two billion people worldwide, built on the proven QuantiFERON-TB Gold Plus technology, QIAreach QuantiFERON-TB is a portable device that enables the ultrasensitive digital detection of TB infection with an end-to-end workflow that is simple and cost efficient, and increases access to reliable Interferon Gamma Release Assay (IGRA) testing. QIAGEN will focus on regions that face a high burden of the disease, and where getting access to lab infrastructure and resources for testing are limited.

"With QIAreach QuantiFERON-TB we have taken a great step towards leaving no one behind when facing a deadly disease like tuberculosis that is preventable and curable. With this groundbreaking new way to detect TB infections we can aid to prevent patients, especially those in high burden countries, from developing the active form of TB," said Thierry Bernard, CEO of QIAGEN. "It combines QIAGEN's proven QuantiFERON-TB technology with a very portable and field-friendly digital device to deliver extremely reliable results without the need for complex laboratory infrastructure at effective cost."

A quantum leap from the traditional TB skin test, QuantiFERON-TB uses blood samples to test for interferon-gamma molecules released from T-cells that have come into contact with TB bacteria. QIAreach QuantiFERON-TB runs these tests on the digital eHub and eStick system, a true walkaway solution with random access and no calibration or maintenance. QIAreach QuantiFERON TB testing requires one patient visit and produces an easy-to-read result in 20 minutes after sample incubation, with the ability to record and send results for improved data management, making it ideal for TB screening programs.

QIAGEN will work with commercial distribution partners as well as the Stop TB Partnership's Global Drug Facility to ensure affordable access across all high burden, low and middle-income countries. In parallel, QIAGEN will continue its close collaboration with a variety of international organizations and public health institutions to help drive scale-up through innovative implementation projects.

"Lack of access to the latest diagnostic tests is just one of the reasons the world is not on track to meet UN Sustainable Development goals to end TB," said Dr. Lucica Ditiu, Executive Director of the Stop TB partnership. "The COVID-19 pandemic saw nine of the countries with the most TB cases cut diagnosis and treatment of the disease by 16-41 percent, setting us back to 2008 levels. Without rapidly rolling out new tools, the commitments made by heads of states to find and treat 40 million people by the end of 2022 will not be met."

Clinical evaluations of the test demonstrated an excellent level of agreement as well as high sensitivity when compared with QuantiFERON-TB Gold Plus, the most recognized, gold standard IGRA marketed worldwide by QIAGEN. The new QIAreach QuantiFERON-TB test was assessed at the Nagasaki Genbaku Isahaya Hospital, Japan, and the six Zambart project sites (Zambia), and shown to be a novel portable and simple-to-use assay that can be implemented with minimal infrastructure for the diagnosis of TB infection.

Published study results can be found here: https://www.sciencedirect.com/science/article/pii/S2531043721001513

Additional study results from Malaysia on QIAreach QuantiFERON-TB will also be featured in a symposium at the 52^nd annual Union World Conference on Lung Health from October 19^th-22 2021, held virtually this year. Further details and event information can be found here: https://theunion.org/our-work/conferences/52nd-union-world-conference-on-lung-health

Find more information on the QIAreach QuantiFERON-TB platform at http://www.qiagen.com/qiareach

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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2021, QIAGEN employed approximately 5,900 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, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; 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.

Category: Corporate

Source: QIAGEN N.V.

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