Hilden, Germany, and Germantown, Maryland, March 24, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) recognized the annual World TB Day 2019 held on March 24 by highlighting its growing global commitment to preventive screening and treatment for latent tuberculosis (TB) infection, a widespread condition that can lead to active TB disease in vulnerable patients.
QIAGEN is investing in several areas regarding ease of use, throughput, screening efficiency and test availability for QuantiFERON-TB worldwide:
- In late 2018 QIAGEN and DiaSorin launched a CE-marked read-out kit for QuantiFERON-TB Gold Plus for use on DiaSorin’s widely used LIAISON platforms. The rollout of QFT-Plus as part of DiaSorin’s broad menu of tests on more than 7,000 LIAISON instruments in hospitals and laboratories around the world adds an efficient automated solution for TB screening programs. Availability of QFT-Plus read-out kits for use on LIAISON platforms is expected in 2019 in the United States and in 2020 in China.
- QIAGEN has partnered with Hamilton Robotics and Tecan for single tube-handling solutions to offer high-efficiency automation of preanalytical processing steps.
- In early 2019 QIAGEN announced plans to develop a novel and proprietary solution, QuantiFERON-TB Access (QFT® Access) that is dedicated and tailored to the needs of low-resource regions with a high disease burden of TB. QFT Access is designed to pair ultrasensitive digital detection of latent TB infection with a complete workflow created with a focus on cost efficiency and ease of use. QIAGEN is developing QFT Access in a new partnership with Ellume, an Australian developer of digitally enabled diagnostics. Clinical trials for QFT Access are planned to start in 2019, and commercialization is expected to begin in 2020.
Health organizations will mark World TB Day 2019 on March 24 with the theme “It’s TIME” – calling for action to eradicate the disease. This year’s messaging includes the statement: “It’s time to test and treat latent TB infection,” which is a testament to the rapidly spreading recognition that testing and treating for latent TB is a very powerful answer to reducing the disease burden. World TB Day is on March 24 each year to commemorate the date in 1882 that Dr. Robert Koch announced his discovery of Mycobacterium tuberculosis, which causes TB.
For World TB Day 2019, QIAGEN is supporting the Stop TB campaign in a “right to know” effort, including donations of QuantiFERON-TB Gold Plus tests to select initiatives.
“Our commitment is stronger than ever to partner with the World Health Organization, STOP-TB, and other organizations as well as governments and healthcare providers around the world to eradicate this disease. With over 10 million deaths a year from TB, the disease burden in terms of human lives and social and economic impact is enormous,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “Leaders in the fight increasingly recognize the critical role of screening for latent TB infection and treating at-risk patients to prevent development of active, contagious tuberculosis. This is the first World TB Day since the high-level United Nations meeting in September 2018, where heads of state agreed to mobilize $13 billion a year by 2022 to implement prevention and care for TB, including preventive testing and treatment for 30 million people.”
Adoption of QIAGEN’s QFT Plus is rapidly growing as global efforts to control tuberculosis intensify and authorities turn to QFT Plus, the industry-leading test for latent TB to replace the less reliable, more time-consuming tuberculin skin test, a 120-year-old technology. QFT-Plus is the fourth generation of QuantiFERON-TB technology, combining a new flexible blood collection workflow with innovative CD4/CD8 T cell technology to enable the most comprehensive TB immune response detection. The proprietary technology of QFT Plus offers the potential to provide important insights for both low and high-risk populations.
QuantiFERON-TB Gold Plus is available in more than 75 countries in North America, Europe, the Middle East, Africa, Asia and Latin America. Nearly 2 million of the new tests have been used so far. QFT-Plus has been adopted by many organizations such as the International Organization for Migration for screening migrants and is the only interferon-gamma release assay (IGRA) endorsed by the International Panel Physicians Association, a physician education group that works with countries that receive immigrants and refugees. 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 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.
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).