QuantiFERON-TB Access (QFT® Access) is a proprietary new test designed to advance tuberculosis control in areas with limited infrastructure, including countries in Asia, Africa and Latin America. The World Health Organization (WHO) has classified 30 countries in these regions as high-burden, representing an estimated 85% of the global TB burden. QFT Access pairs highly sensitive digital detection with a complete workflow created to deliver cost-efficient results quickly and with unmatched simplicity. It eliminates the need for an extensive laboratory infrastructure while providing best-in-class QuantiFERON technology. Clinical trials are being conducted in 2019, and commercialization of QFT Access is expected to begin in 2020.

“We are pleased that UNAIDS selected QuantiFERON-TB Access for recognition at the Health Innovation Exchange. QIAGEN’s drive to develop QFT Access springs from the need for a modern, accurate test for TB infection screening in areas where the disease burden is high but resources and infrastructure are scarce,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “QFT Access builds on the success of QuantiFERON®-TB Gold Plus, the modern gold standard for detection of latent TB infection. We have created a field-friendly Sample to Insight solution using a simple test to reduce costs and labor and avoid the need for cold chain, a computer or continuous power supply.”

QIAGEN is developing QuantiFERON-TB Access in partnership with Ellume, an Australian developer of digitally-enabled diagnostics. QFT Access is a single visit, single tube test using 1 ml blood test that is scalable. It is not impacted by BCG vaccination, which can cause false-positive results with the tuberculin skin test used in many low-resource settings. QFT Access requires less than five minutes of hands-on time from a technician or phlebotomist. The result can be digitally displayed on a portable device or, optionally, connected to a computer for printout or electronic transmission. The system does not require maintenance or calibration, and it minimizes the impact of power loss or dust.

This novel solution for high-burden regions builds on the success of QIAGEN’s fourth-generation QuantiFERON-TB Gold Plus (QFT®-Plus), which is registered in more than 75 countries and is the market-leading blood test for latent TB infection. The QuantiFERON®-TB technology delivers faster, less labor-intensive and more accurate insights than the century-old tuberculin skin test. To learn more about QuantiFERON-TB tests and tuberculosis control, please visit www.quantiferon.com.

Tuberculosis is a contagious bacterial infection spread primarily through coughing by patients with the active pulmonary form of the disease. In 2017, according to WHO estimates, there were 10 million new cases of active TB worldwide and 1.6 million deaths, including 300,000 from HIV-associated tuberculosis. In latent tuberculosis infection, the bacterium infects a person but produces no symptoms unless it progresses to active disease, when the patient becomes highly contagious. In the global effort to eradicate TB, WHO and other organizations have expanded their guidelines for screening high-risk individuals and treating those with latent infections to help prevent further contagion and reduce the disease burden.

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).