QIAGEN Expands Syndromic Testing Portfolio with the Launch of Higher-Capacity QIAstat-Dx Rise and Enhanced Panels

Rhea-AI Summary

QIAGEN has launched the QIAstat-Dx Rise, an advanced automated syndromic testing system receiving CE-marking, enabling up to 56 tests in an eight-hour shift. The system enhances the capacity for detecting multiple pathogens simultaneously, crucial for high-demand medical facilities. Key updates include an expanded QIAstat-Dx Respiratory SARS-CoV-2 Panel that now tests for 23 pathogens, including Chlamydophila pneumoniae, and a new Gastrointestinal Panel with improved performance. Additionally, a software update enhances cybersecurity and connectivity for the QIAstat-Dx systems.

Positive

• Launch of QIAstat-Dx Rise increases testing capacity to 56 tests in eight hours.
• Expanded QIAstat-Dx Respiratory Panel now detects 23 pathogens.
• Improved Gastrointestinal Panel for detecting multiple infection-causing pathogens.
• Software upgrade enhances cybersecurity and usability of QIAstat-Dx systems.

Negative

• None.

• 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

HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)-- 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

View source version on businesswire.com: https://www.businesswire.com/news/home/20220515005044/en/

QIAGEN:

Investor Relations

John Gilardi +49 2103 29 11711

Phoebe Loh +49 2103 29 11457

e-mail: ir@QIAGEN.com

Public Relations

Thomas Theuringer +49 2103 29 11826

e-mail: pr@QIAGEN.com

Source: QIAGEN N.V.

FAQ

What is the significance of the QIAstat-Dx Rise launch by QGEN?

The QIAstat-Dx Rise enhances pathogen testing capabilities, enabling high-capacity testing for medical institutions.

What pathogens does the QIAstat-Dx Respiratory SARS-CoV-2 Panel now test for?

The panel now tests for 23 pathogens, including the newly added Chlamydophila pneumoniae.

How does the upgraded QIAstat-Dx software improve functionality?

The software upgrade enhances cybersecurity, usability, and connectivity features for the QIAstat-Dx systems.

When was the QIAstat-Dx Rise system awarded the CE-marking?

The CE-marking for QIAstat-Dx Rise was awarded recently, allowing for expanded syndromic testing capabilities.

What improvements were made to the QIAstat-Dx Gastrointestinal Panel?

The Gastrointestinal Panel has been updated with improved sample preparation and performance for detecting 22 infectious targets.