QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Gold Plus Test on LIAISON platforms and begin commercial launch
Nov 27 2019

QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Gold Plus Test on LIAISON platforms and begin commercial launch

Enabling highly automated screening solution for latent tuberculosis in all throughput segments

Germantown, Maryland; Hilden, Germany; and Saluggia, Italy, November 27, 2019QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and DiaSorin (FTSE MIB: DIA) today announced the U.S. launch of an automated workflow for QuantiFERON-TB Plus (QFT-Plus), the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s LIAISON platforms.

The U.S. Food and Drug Administration (FDA) approved the LIAISON QuantiFERON-TB Plus Test, developed by QIAGEN and DiaSorin to offer streamlined laboratory automation for latent TB screening, supporting the conversion from tuberculin skin tests to modern blood-based QuantiFERON technology. The highly automated workflow on LIAISON platforms provides QuantiFERON customers a powerful, highly flexible automation option for all throughput ranges.

Embedding QuantiFERON assays in the broad assay menu of DiaSorin’s LIAISON analyzers also gives current LIAISON customers an attractive new assay option with significant growth potential. The workflow pairs QIAGEN’s standard QuantiFERON-TB Gold Plus Blood Collection Tubes (QFT-Plus BCT, containing the core QuantiFERON technology) with DiaSorin’s newly launched LIAISON QuantiFERON-TB Plus detection assay. More than 8,000 LIAISON systems have been placed worldwide, primarily in hospital laboratories.

“We are pleased to announce FDA approval of the LIAISON QuantiFERON-TB Gold Plus Test for use on the LIAISON platform and the broad-based initiation of our launch for this new automation option in the United States. The validation of the QuantiFERON technology with the LIAISON platforms further reinforced the clinical profile of QuantiFERON-TB Gold Plus,” said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area. “QFT-Plus users are gaining access to the LIAISON’s powerful, highly flexible automation for all throughput segments, as well as to LIAISON’s broad menu of more than 100 tests. The LIAISON workflow for QFT-Plus was introduced in Europe in 2018 and is planned for China in 2020. Combined with front-end automation options for liquid handling, the LIAISON workflow for QFT-Plus delivers significant gains in turnaround time and efficiency.”

“Today we made a step further in our strategy to drive the conversion to the most advanced solution available in the market for the detection of latent tuberculosis,” Carlo Rosa, Chief Executive Officer of DiaSorin Group, commented. “LIAISON QuantiFERON-TB Gold Plus Test, already available in Europe since September 2018, is now available in the United States on the LIAISON family platforms and we believe this solution for laboratories will furtherly strengthen our positioning as a specialty player”.

QIAGEN and DiaSorin initiated a collaboration in 2017 to develop new tests for the LIAISON family of analyzers based on QIAGEN assay technologies. Additional tests based on QuantiFERON technology, which provides a unique, efficient way to detect asymptomatic infections and other risks that may not be detected with standard diagnostic technologies, are planned for adaptation to the LIAISON platforms.

In addition to the DiaSorin collaboration, QIAGEN is partnering with two leaders in liquid handling solutions to provide options for automated pre-analytical processing for customers who implement the single-tube collection process for QFT-Plus. These collaborations enable customers to use the Hamilton Robotics Microlab® STAR™ automated liquid handling workstation or the Tecan Fluent® Laboratory Automation workstation to automate the manual step of aliquoting samples from a single collection device (such as a standard lithium heparin blood collection tube) into QuantiFERON-TB Gold Plus tubes for analysis.

QuantiFERON-TB Gold Plus is registered in more than 75 countries in North America, Europe, Asia, Africa and Latin America. QIAGEN’s QuantiFERON-TB Gold (QFT) and QFT-Plus tests are the market-leading blood tests for latent TB, with faster, less labor-intensive and more accurate insights than the century-old tuberculin skin test. QFT-Plus also has the future potential to deliver increased clinical utility by adding measurement of CD8+ T-cell immune response to detection of CD4+ response. CD8+ T-cells have been shown to play an important role in the development of active TB, and QFT-Plus has been cited by international agencies for its potential benefit among migrants and other populations.

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 TB, 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 international organizations have expanded their guidelines for screening high-risk individuals and treating those with latent infection to help prevent further contagion and reduce the disease burden.

To learn more about QuantiFERON-TB tests and tuberculosis control, please visit www.quantiferon.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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2019, QIAGEN employed approximately 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

About DiaSorin

Headquartered in Italy and listed in the FTSE MIB Index, DiaSorin is a global leader in the In Vitro Diagnostic (IVD) field. For over 50 years the Company has been developing, producing and marketing reagent kits for IVD worldwide. The Group has a presence on the 5 continents with 24 companies, 5 foreign branches, 6 manufacturing facilities and 5 research centers throughout the world. Through constant investments in research and development, and using its own distinctive expertise in the field of immunodiagnostics to deliver a high level of innovation, DiaSorin offers today the broadest range of specialty tests available in the immunodiagnostics market and new tests in the molecular diagnostics markets, which identify DiaSorin Group as the “Diagnostic Specialist.” Further information at http://www.diasoringroup.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).

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