JAN 07 2019

QIAGEN to develop QuantiFERON®-TB Access as a new test for low-resource, high-burden regions in global fight against TB

Adapting the power of QuantiFERON®-TB technology to advance global TB control efforts in new partnership with Ellume

Hilden, Germany, and Germantown, Maryland, January 7, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced plans to develop a proprietary new version of a QuantiFERON^®-based tuberculosis (TB) test dedicated and tailored to the needs of low-resource regions with a high disease burden of TB. 

The new testing solution, QuantiFERON^®-TB Access (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 high-performance digitally-enabled diagnostics. Clinical trials for QFT Access are planned to start in 2019, and commercialization is expected to begin in 2020.

QFT Access has been designed to advance TB control in areas with limited infrastructure, including countries in Asia, Africa and Latin America. The World Health Organization (WHO) has classified a group of 30 countries in these regions as high-burden, representing an estimated 85% of the global TB burden. QIAGEN intends to work with the WHO, various non-governmental organizations and governments to support their TB control efforts, in particular to achieve the goals set for the WHO's End TB Strategy.

“QuantiFERON-TB Gold Plus is rapidly winning adoption in developed markets as an important way to detect latent TB infections and prevent patients from developing the active form of this potentially deadly disease,” said Thierry Bernard, Senior Vice President of QIAGEN’s Molecular Diagnostics Business Area. “Despite the urgent need for more latent TB testing in low-resource, high-burden parts of the world, a lack of infrastructure and shortage of trained technicians make adoption of modern tests challenging. QuantiFERON-TB Access offers a novel solution for this challenge by combining the proven clinical insights of QuantiFERON-TB with Ellume’s digital technologies to deliver cost-efficient results quickly and without need for a laboratory, and a further signal of our support in the global fight against TB.”

“QuantiFERON-TB Access represents the biggest technology breakthrough in latent TB infection testing since the first FDA approval of QuantiFERON-TB in 2001,” said Dr. Masae Kawamura, M.D., Senior Director, TB Medical and Scientific Affairs, at QIAGEN. “The ease of use for QFT Access and ability to get results in one visit can enable the evaluation of contacts of active TB patients in high-burden regions where screening is not currently performed due to lack of access to laboratories or the ongoing global shortage of high-quality tuberculin used in skin testing. The use of QFT Access addresses the issues of cost and complexity with a solution dedicated and tailored to the specific needs of these regions, and aims to provide a much-needed tool to help the world eliminate TB and achieve the UN and WHO goals.”

Ellume’s Founder and Managing Director, Dr. Sean Parsons, said, “We’re pleased to be partnering with a global leader such as QIAGEN to create a high-impact product such as QFT Access. Tuberculosis, particularly as drug-resistant TB, is an often-fatal bacterial infection and a serious threat to humankind. We are confident that Ellume’s technology will assist QIAGEN with detection of TB infections, leading to earlier identification and more effective treatment and containment in low-resource, high-burden countries. At Ellume, we pride ourselves on developing integrated solutions and we’re confident that our partnership with QIAGEN will create a world-class product in QFT Access to address this major unmet need.”

QFT Access is being designed with important features and benefits that include:

• Built on proven QuantiFERON-TB technology: QFT Access is a novel ultrasensitive QuantiFERON assay specifically dedicated and designed to bring a version of this powerful technology to low-resource, high-burden regions. The assay eliminates cross-reactivity with the BCG vaccines and most of the environmental mycobacteria that frequently cause false-positive skin test results. 
• Scalable solution for low-resource, high-burden areas: QFT Access has been designed to ensure both clinical efficacy and cost efficiency. It is very simple to use, with assay processing and read-out requiring minimal hands-on time and no laboratory. QFT Access tests can be completed with only one patient visit and in about 24 hours, unlike the skin test that requires two visits and requires a physician for assessment. The blood sample is also available for retesting, as needed, and data can be stored for later referral. The single-tube test is incubated for about 16-24 hours, and then results are determined in 5-20 minutes on a small proprietary, single-use cartridge. Results are displayed in real time on a compact hub, which can be operated using battery or USB power sources and independently of a computer.
• Designed for rapid adoption and future menu expansion: QFT Access can be implemented quickly in screening programs that are increasingly part of TB control efforts in low-resource regions, in particular since usage requires only limited healthcare worker training. QFT Access also has potential to be used for latent TB testing in combination with other tests, such as for HIV infection, as well as for future use in detecting other disease targets. These are especially critical given the high burden of TB and HIV co-infection in the high-burden countries. 

QFT Access builds on the success of QFT-Plus, which is registered in more than 75 countries in North America, Europe, Asia, Africa and Latin America. QIAGEN’s fourth-generation QFT-Plus is the market-leading blood test for latent TB infections, with 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 2016, there were 10.4 million new cases of active TB worldwide and 1.7 million deaths from this airborne disease, according to WHO estimates. In latent tuberculosis infection, the bacterium infects a person but produces no symptoms unless it progresses to active disease, at which stage the patient is highly contagious. As part of comprehensive programs 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.

About Ellume

Ellume is an Australian-based digital diagnostics company that develops, manufactures and commercializes high-performance, connected products for health professionals and consumers. Our focus is on the detection of common illnesses which affect the global population and our products differ from conventional diagnostics through performance, digital connectivity, actionability and simplicity. Ellume has developed novel detection technology powered by our unique quantum dot nanoparticle, which integrates optics, electronics, biologics and software into an intuitive and high-performance digital platform. Ellume has a global partnership in consumer health with GlaxoSmithKline, a global partnership with QIAGEN in latent TB, and a range of professional products under the ellume·lab brand which are scheduled for US launch in 2020. Further information can be found at www.ellumehealth.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 September 30, 2018, QIAGEN employed approximately 4,900 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, 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).

https://corporate.qiagen.com/newsroom/press-releases/2019/20190107_QFT_Access