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New tests for QIAstat-Dx syndromic solution to distinguish between gastrointestinal pathogens (U.S. submission) and between meningitis and encephalitis infections (CE-IVD registration)
Higher-capacity QIAstat-Dx Rise platform set for CE-IVD launch in mid-2022, provides new option to enable labs and hospitals to increase testing volumes with enhanced walk-away efficiency through unique QIAstat-Dx Rise Smart drawer to automate processing
QIAstat-Dx cartridges designed for use on expanded series of QIAstat-Dx options offering random access to process one, four or eight tests simultaneously
HILDEN, Germany & GERMANTOWN, Maryland, January 10, 2022--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced important enhancements in the commercialization of its QIAstat-Dx syndromic testing solution – which enables laboratories and hospitals worldwide to test patients for multiple pathogens from one sample – with new tests and the launch of a higher-throughput version that includes a new level of walk-away efficiency through the new QIAstat-Dx Smart Drawer.
The test enhancements for QIAstat-Dx, a fully integrated molecular diagnostic testing solution with one-step sample processing that provides results in about one hour, involve:
The submission of a Gastrointestinal (GI) panel for U.S. regulatory approval designed to detect 22 common viral, bacterial and parasitic pathogens that can cause potentially life-threatening infections. QIAGEN launched a first version of this multiplex test in Europe in 2019 and is planning to submit an updated version for IVDR review and approval in 2022.
The CE-registration of a Meningitis / Encephalitis panel in Europe designed to detect 15 different pathogens and help to distinguish between meningitis (inflammation of the membrane surrounding the brain and spinal cord) and encephalitis (inflammation within the brain). The test analyzes 15 pathogens simultaneously and enables clinicians to undertake a one-step, fully integrated molecular diagnosis of either condition in about one hour.
The new panels build on the successful uptake of two different respiratory tests designed for use on QIAstat-Dx, which is available worldwide. The QIAstat-Dx Respiratory+ test can detect 22 different respiratory pathogens, including the SARS-CoV-2 virus (including Delta and Omicron variants of interest), while the QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test is a so-called four-plex test designed for detection of the coronavirus as well as influenzas A or B, and respiratory syncytial virus (RSV).
"The expansion of the test menu will increase the utility of QIAstat-Dx for customers around the world, and build on the urgent medical needs created with COVID-19 that continues demonstrate the relevance and value of syndromic testing," said Jean Pascal Viola, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. "Complementing the menu expansion is the introduction of QIAstat-Dx Rise as a new option for our customers to handle the increasing demand for rapid test results."
Building on the currently available QIAstat-Dx Analyzer with one to four analytical modules, and both systems using the same test cartridges, QIAstat-Dx Rise is planned to be made available with the European CE marking to customers in the middle of 2022. The submission for U.S. regulatory approval is planned for the end of 2022.
QIAstat-Dx Rise has random access capacity to hold up to 18 different tests for processing, and leading to up to 56 tests in an eight-hour shift and 160 tests per day with eight analytical modules.
This new version will enable customers to raise testing efficiency and their "walk-away" time with the new QIAstat-Dx Smart Drawer. This feature automatically detects sample types for the QIAstat-Dx panels, provides digital cartridges traceability and prioritization, and enables immediate urgent testing. With a footprint less than 60 cm, the system also requires minimal lab space and can be placed as a stand-alone device on any lab bench.
For more information, please visit: https://www.qiagen.com/de/applications/syndromic-testing
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 December 31, 2021, QIAGEN employed more than 6,000 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).
Source: QIAGEN N.V.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220110005681/en/
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