• QIAstat-Dx Rise, which can process up to 56 tests in an eight-hour shift with enhanced walk-away efficiency, receives CE-marking to run new respiratory and gastrointestinal panels

• QIAstat-Dx Respiratory SARS-CoV-2 Panel with CE-marking expanded to 23 pathogens, now includes Chlamydophila pneumoniae to detect bacteria that is major cause of respiratory infections

• QIAstat-Dx Gastrointestinal Panel 2 with CE-marking launched with expanded pathogen target list and improved sample preparation and panel performance

• Software upgrade improves cybersecurity, usability and connectivity features on QIAstat-Dx systems, adding to the cloud-based connectivity solution QIAsphere

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of QIAstat-Dx Rise – a high-capacity version of the QIAstat-Dx automated syndromic system – and enhancements to the menu of tests for the fully integrated one-step molecular testing solution that provides results in about one hour.

The launch of QIAstat-Dx Rise comes after the award of European CE-marking that significantly expands QIAGEN’s offering in syndromic testing, which is becoming an increasingly important tool in laboratories settings to test simultaneously for multiple pathogens from one sample.

“The launch of QIAstat-Dx Rise syndromic testing platform provides automated, comprehensive pathogen testing for higher-demand medical institutions,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “Crucially, QIAstat-Dx Rise is compatible with our updated QIAstat-Dx Respiratory SARS-CoV-2 Panel, the QIAstat-Dx Gastrointestinal Panel 2, as well as all of our future assays.”

QIAstat-Dx Rise and its test cartridges are a closed system for hands-off sample preparation and processing. With a random access capacity of up to 18 different tests, it can provide diagnostic results for up to 56 tests in an eight-hour shift and 160 tests per day by using eight analytical modules. Building on the existing QIAstat-Dx Analyzer with up to four analytical modules, QIAstat-Dx Rise is a flexible new option for increased testing capacity.

Among other developments in the QIAstat-Dx portfolio:

• The CE-marked QIAstat-Dx Respiratory SARS-CoV-2 Panel has been expanded to test for an additional target, Chlamydophila pneumoniae, a bacteria that is cause of respiratory infections that can present with influenza-like symptoms. This panel can now be used to detect and differentiate among 23 viral and bacterial targets that cause respiratory infections. While C. pneumoniae typically causes mild illness, it can cause severe outcomes in high-risk populations, particularly older adults.

• The CE-marked QIAstat-Dx Gastrointestinal Panel 2 has also been updated with new features for improved sample preparation and panel performance. This panel can be used to detect and differentiate among 22 viral, bacterial and parasitic targets that cause gastrointestinal infections. Importantly, the panel’s STEC target (Shiga-like toxin E.coli) reports the toxin content (stx1 and stx2). This information can be used to determine the risk of certain patient populations to Hemolytic Uremic Syndrome (HUS) and therefore can help provide the right patient monitoring.

• QIAGEN also released a software upgrade for QIAstat-Dx Analyzer that enhances the system’s cybersecurity, usability and connectivity features. The release of software version 1.5.1 enables users to configure their devices to perform mandatory External Quality Control tests. The new software adds to the QIAsphere cloud-based connectivity solution that enhances QIAstat-Dx capabilities in digital diagnostics.

To learn more about QIAGEN’s range of QIAstat-Dx devices and testing panels, visit QIAGEN.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), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of March 31, 2022, QIAGEN employed more than 6,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.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, 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.

Category: Corporate

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