Hilden, Germany, and Germantown, Maryland, October 15, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the European rollout of its next-generation QIAstat-Dx panel for one-step, fully integrated molecular analysis of gastrointestinal (GI) syndromes. The multiplex gastrointestinal panel, which QIAGEN has upgraded to now include comprehensive viral coverage detects the 24 most common viral, bacterial and parasitic pathogens that cause GI infections. A respiratory panel for QIAstat-Dx analyzes 21 viral and bacterial pathogens including sub-types of influenza, coronaviruses, pneumonia and other targets, to differentiate the causes of acute respiratory tract infections.
The QIAstat-Dx system, which already had received CE-IVD marking along with the gastrointestinal and respiratory panels, recently achieved registration in Australia and is being launched there. Plans for U.S. regulatory submission of QIAstat-Dx and both panels are on track for expected approval in 2019. QIAGEN also expects to introduce a QIAstat-Dx multiplex test for meningitis, with CE-IVD marking, in 2019. A deep menu of assays is under development for syndromic testing in oncology and other therapeutic areas.
“Hospitals, laboratories and clinics are embracing QIAstat-Dx as an easy-to-use, next-generation solution for reliable diagnosis of complex syndromes. With less than one minute of hands-on time and results in about an hour, a clinic assistant or technician can run multiple samples and gain reliable, highly sensitive molecular insights that differentiate the causes of respiratory or gastrointestinal syndromes,” said Thierry Bernard, QIAGEN’s Senior Vice President, Molecular Diagnostics Business Area. “The simplicity of QIAstat-Dx brings the power of real-time PCR (polymerase chain reaction) technology close to the patient. A user just inserts a sample cartridge and walks away, and the instrument automatically handles all of the steps of multiplex molecular analysis – enabling the clinician to make informed treatment decisions.”
The demand for syndromic testing with molecular diagnostics is growing rapidly. In gastrointestinal syndromes, the number of test panels currently being run is estimated at 2.6 million per year in the United States and about 2 million in Europe, with a relatively small but fast-growing number of those tests using molecular diagnostics. In respiratory syndromes and flu testing, QIAGEN estimates the total addressable market at about 1.5 million tests per year in the United States and 1.1 million in Europe.
QIAstat-Dx employs cost-efficient, single-use cartridges with built-in sample processing and all reagents on board. In about one hour, QIAstat-Dx can provide insights into the precise cause of hard-to-diagnose syndromes. The system is designed to operate in near-patient clinical settings, eliminating the delay of sending samples to a centralized laboratory. The easy-to-use cartridges are processed in a scalable proprietary analyzer, which can be configured from one to eight modules, independently running cartridges from predefined assay protocols via a touchscreen with simple step-by-step directions. For more information, please visit http://www.qiagen.com/ie/shop/detection-solutions/qiastat-dx.
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 June 30, 2018, QIAGEN employed approximately 4,800 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.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, 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).