QIAGEN’s QuantiFERON®-TB Gold Plus test added to the Global Drug Facility catalog for public health efforts
Oct 29 2019

QIAGEN’s QuantiFERON®-TB Gold Plus test added to the Global Drug Facility catalog for public health efforts

  • QIAGEN expands market for gold standard latent TB test to help developing countries fight TB
  • WHO-endorsed test to support communities with the highest need
  • First demonstration of QuantiFERON®-TB Access at the Union World meeting in India

 

Hilden, Germany, and Germantown, Maryland, October 29, 2019 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QuantiFERON®-TB Gold Plus (QFT®-Plus) has been added to the diagnostic catalog of the Stop TB Partnership’s Global Drug Facility (GDF), opening a new channel to reach countries with a high incidence of tuberculosis (TB), in particular areas where QIAGEN has no direct commercial presence.

The GDF is the largest provider to the public sector of quality-assured tuberculosis medicines, diagnostics and laboratory supplies. Operating a unique pooled procurement system, the GDF facilitates access and helps match demand for TB diagnostics and drugs with funding from donors, governments and non-governmental organizations.

The acceptance of QFT-Plus for the GDF catalog advances QIAGEN’s strategy to help expand screening with modern blood-based assays for latent TB infection in regions with a high disease burden but limited resources. In addition, QIAGEN is working with the World Health Organization (WHO), governments and NGOs (non-governmental organizations) in the global fight to eradicate TB. In its Global Tuberculosis Report 2019, the WHO endorsed QFT-Plus for diagnosis of latent TB infection as part of its new guidelines to target prevention in the goal to eradicate TB. QIAGEN is supporting QFT-Plus accessibility through GDF with additional training and educational programs.

In partnership with Ellume, QIAGEN is also developing QuantiFERON®-TB Access (QFT Access), a proprietary new QuantiFERON-based workflow designed to bring the technology to communities lacking access to complex laboratory infrastructure. This will strengthen QIAGEN’s effort to provide high burden, low resource countries with the best-in-class solution for latent TB testing, whether it be QFT-Plus or QFT Access.

“We are pleased to support the Stop TB Partnership’s campaign to end TB by offering QuantiFERON-TB Gold Plus at an appropriate reduced price to bring faster, less labor-intensive and more accurate insights for detection of latent TB infections in developing regions, where the danger of TB can be the greatest. QIAGEN is a committed partner in public health and educational efforts, and latent TB screening and treatment are now recognized as essential to defeating tuberculosis,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area and Interim CEO at QIAGEN. “The GDF listing will make QFT-Plus, the leading modern blood test for detection of latent TB infections, available in low-resource areas with support from centralized laboratories. The future addition of QFT Access will provide a highly accurate option for areas that may lack laboratories, electricity or other support systems, in order to test and treat those potentially infected with the deadly disease.”

QFT Access will be in clinical trials this year, with commercialization expected to begin in 2020, and will be demonstrated for the first time at the Union World Conference on Lung Health this week in Hyderabad, India. About 6,000 clinicians, public health workers, policymakers, researchers and advocates will attend the conference, which focuses on the health challenges of low- and lower-middle income populations. QFT Access pairs highly sensitive digital detection with a complete workflow designed to deliver cost-efficient results quickly and with unmatched simplicity. WHO’s Global Tuberculosis Report 2019 cites QFT Access as incorporating the benefits of QuantiFERON-TB Gold Plus with “the potential to provide an alternative detection system that is simpler than the current IGRAs” (interferon gamma release assays, the modern blood tests for latent TB infection).

QuantiFERON-TB Gold Plus combines a flexible 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 approved by the adopted by many organizations such as the International Organization for Migration and the International Panel Physicians Association. More than 40 peer-reviewed publications to date have supported the performance of QFT-Plus, and two recent meta-analysis have highlighted the improved performance in key TB infection risk groups. 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. The World Health Organization estimates there were 10 million new cases of active TB worldwide and 1.5 million deaths from TB in 2018. WHO estimates about 23% of the world’s population, 1.7 billion people, have latent TB infection and could be at risk of developing active TB disease.

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, 2019, QIAGEN employed approximately 5,200 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 net sales, net sales of particular products (including anticipated sales of its QuantiFERON latent TB Test, its portfolio of next generation sequencing solutions and QIAstat-Dx), adjusted net sales, adjusted diluted earnings per share results, product launches (including anticipated launches of digital PCR products, a new version of its QuantiFERON-TB test, QuantiFERON-TB Access, the QIAstat-Dx panel for respiratory conditions and a CE-IVD marked panel for meningitis), placements of QIAsymphony modular PCR instruments, improvements in operating and financial leverage, currency movements against the U.S. dollar, and plans for investment in its portfolio and share repurchase commitments, 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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