QIAGEN Launches EZ2 Connect MDx Platform for Automated Sample Processing in Diagnostic Labs

Rhea-AI Summary

QIAGEN has launched the EZ2 Connect MDx platform for diagnostic laboratories, enhancing sample processing capabilities 18 months after its research introduction. This automated device purifies DNA and RNA from 24 samples in approximately 30 minutes and is CE-IVD compliant, enabling its use across the EU, U.S., Canada, and more. With over 5,000 EZ platforms deployed globally, EZ2 Connect MDx integrates with the QIAsphere digital system for remote management, meeting the fast-paced demands of clinical diagnostics. It addresses various sample types, employing magnetic-bead technology and ensuring high process safety.

Positive

• Launch of EZ2 Connect MDx enhances market reach in diagnostics.
• CE-IVD compliance allows access to EU and other international markets.
• The platform can process 24 samples in about 30 minutes, increasing lab efficiency.
• Over 5,000 cumulative placements of EZ platforms worldwide highlight strong market acceptance.
• Integration with QIAsphere digital system improves lab management and operation.

Negative

• None.

• Start of worldwide diagnostic use follows the launch of upgraded EZ2 Connect for research use in 2021, builds on the success of EZ1 Connect platform found in thousands of labs worldwide
• EZ2 Connect MDx puts standardized, efficient nucleic acid purification in reach of any clinical lab combined with QIAsphere digital system that allows for remote instrument management
• Over 5,000 cumulative placements of EZ platforms worldwide through the end of 2022

VENLO, The Netherlands--(BUSINESS WIRE)-- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of EZ2 Connect MDx for use in diagnostic laboratories, making the IVD platform for automated sample processing available for widescale use 18 months after being made available for research.

With a high degree of automation, the EZ2 Connect MDx enables labs to purify DNA and RNA from 24 samples in parallel in as little as 30 minutes¹. The device now carries the EU’s CE-IVD compliance marking for in-vitro devices (IVD) for the European Union and other countries that accept this designation. It is also available in the United States, Canada and other countries.

“EZ2 Connect MDx puts standardized and efficient nucleic acid purification in reach of any clinical lab,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “It solves the challenges of many clinical diagnostics labs that have to provide diagnostics results quickly, that have to deal with fluctuating sample numbers as well as a large variety of sample types and quality.”

EZ2 Connect MDx can extract nucleic acids from blood plasma, serum, stool and other sample types using magnetic-bead technology. High process safety is ensured with prefilled and sealed reagent cartridges, as well as load checking through integrated cameras. Other features include UV decontamination, onboard pipetting and heating as well as automated piercing of the sealed cartridge. The resulting analyte is compatible with a variety of downstream technologies such as real-time PCR, digital PCR and next-generation sequencing.

EZ2 Connect MDx complements QIAGEN’s leading offering of automated IVD nucleic extraction platforms, which includes QIAcube Connect MDx and QIAsymphony.

EZ2 Connect MDx is designed to handle a wide range of sample material thanks to QIAGEN’s elaborate kit portfolio and customizable protocols. It can be used in research mode with research kits (MBA) or in dedicated IVD mode with EZ1 DSP kits as well as protocols for diagnostic workflows. Another key feature is the ability to use the QIAsphere digital laboratory ecosystem, which enables full integration into the digital infrastructure of a lab that allows for remote instrument management.

The new platform builds on QIAGEN’s EZ1 family of devices, which set new standards in sample-prep automation and sample-data management. The EZ2 combines the ease of use, process safety and robustness of the EZ1 with improved throughput and digital features. More than 5,000 EZ1 and EZ2 instruments have been placed worldwide through the end of 2022.

To learn more about EZ2 Connect MDx, please visit: https://www.qiagen.com/products/ez2-connect-mdx

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 September 30, 2022, QIAGEN employed more than 6,200 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).

¹ Protocol run time varies depending on the number of samples processed and the protocol selected.

Source: QIAGEN N.V.

Category: Corporate

View source version on businesswire.com: https://www.businesswire.com/news/home/20230117005568/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

Daniela Eltrop

e-mail: pr@QIAGEN.com

Source: QIAGEN N.V.

FAQ

What is the significance of the EZ2 Connect MDx launch for QGEN?

The launch of EZ2 Connect MDx marks an expansion into diagnostic laboratories, increasing QGEN's product offerings and market reach.

What does CE-IVD compliance mean for QIAGEN's EZ2 Connect MDx?

CE-IVD compliance allows EZ2 Connect MDx to be used for in-vitro diagnostics in the EU and other countries, expanding its market potential.

How many samples can EZ2 Connect MDx process at once?

EZ2 Connect MDx can purify DNA and RNA from 24 samples simultaneously in approximately 30 minutes.

What technology does EZ2 Connect MDx use for nucleic acid extraction?

EZ2 Connect MDx employs magnetic-bead technology for efficient nucleic acid extraction from various sample types.

How does QIAsphere enhance the functionality of EZ2 Connect MDx?

The QIAsphere digital system allows for remote instrument management, improving the operational efficiency of clinical labs.