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; November 27, 2019
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.
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.
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.
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).