High sensitivity and specificity, plus insights for quantifying infections and identifying co-infections
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the publication of a multicenter clinical study demonstrating the accuracy of its QIAstat-Dx syndromic testing solution for diagnosing the causes of acute gastroenteritis. The QIAstat-Dx Gastrointestinal Panel delivered high performance compared to other, existing multiplex tests in this study which evaluated 385 patient samples at university hospital laboratories across Europe.
The study showed the QIAstat-Dx Gastrointestinal Panel was highly sensitive (98.2% positive percent agreement, a measure of ability to detect pathogens) and specific (99.9% negative percent agreement, a measure of ability to identify true negative samples). Multiple pathogens were identified in nearly one-third of the patient samples that tested positive. Authors emphasized the system's "ease of use" and that the system and assay yielded results in approximately one hour. The study also cited the ability of the QIAstat-Dx panel to provide cycle threshold (CT) values and amplification curves, quantitative indications of the amount of nucleic acids detected, as a unique advantage in interpreting diagnostic findings for gastrointestinal syndromes, which can be complicated by co-infections or false positives in testing. These are important capabilities which other currently widely used syndromic platforms do not offer.
The article, "Multicenter evaluation of the new QIAstat Gastrointestinal Panel for the rapid syndromic testing of acute gastroenteritis," has been accepted for publication by the European Journal of Clinical Microbiology Infectious Diseases (EJCMID) and is available online. The study was conducted at Copenhagen University Hospital Hvidovre in Denmark and University Hospital of Bonn in Germany.
"Insights from our QIAstat-Dx syndromic testing solution offer real value for clinicians as rapid and efficient decision support for their evaluation of complex and sometimes life-threatening infections. This new study adds to the rapidly growing base of evidence that the QIAstat-Dx gastrointestinal panel delivers excellent results in an easy-to-use workflow," said Thierry Bernard, Senior Vice President and Head of Molecular Diagnostics for QIAGEN. "Traditional gastrointestinal testing is costly, time consuming and labor intensive. The QIAstat-Dx GI panel addresses these challenges and can thereby create real value of laboratories, clinicians and patients. Demand for syndromic testing is growing rapidly, and QIAstat-Dx brings the next-generation solution to accurately evaluate infections and other diseases that manifest as a set of symptoms with uncertain causes. The system has many unique advantages, including being the only solution to provide CT values to users."
Introduced in Europe in early 2018 and the United States in mid-2019, the QIAstat-Dx system enables fast, cost-effective and easy-to-use syndromic testing with novel Sample to Insight solutions. The QIAstat-Dx Gastrointestinal Panel provides differential detection of more than 20 bacterial, viral and parasitic pathogens implicated in gut infections. The panel is already available in Europe. The QIAstat-Dx Respiratory Panel, for detection of more than 20 common viral and bacterial infections in respiratory syndromes, is currently available in Europe and the United States.
QIAGEN is developing a broad pipeline of planned assays for the QIAstat-Dx content menu, spanning infectious diseases, oncology, companion diagnostics and other disease areas.
For more information, please visit www.QIAstat-Dx.com.
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.
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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