• QIAcube Connect MDx carries CE-IVD marking in Europe and will be launched globally
• Device allows labs to use in-vitro diagnostics (IVD) and more than 140 other QIAGEN standard protocols
• Platform builds on success of over 9,800 installed QIAcube and QIAcube Connect instruments
Germantown, Maryland, and Hilden, Germany, March 02, 2021 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the global launch of the QIAcube Connect MDx, a flexible platform for automated sample processing that will now be available to molecular diagnostic laboratories in the U.S. and Canada, the European Union and other markets worldwide.
QIAcube Connect MDx is an enhanced instrument from the QIAcube product line for in-vitro diagnostic applications (IVD) that tests samples taken from the human body. The fully automated, flexible system with diagnostic and research protocols can be used in combination with QIAGEN’s gold standard QIAamp DSP kits and PAXgene Blood RNA extraction kits.
This expansion to clinical applications complements the use of QIAcube Connect and the QIAcube HT instruments in life science applications. QIAGEN has placed more than 9,800 instruments of the QIAcube instrument family by the end of 2020. It also further enhances QIAGEN’s automated sample preparation portfolio led by the QIAsymphony flagship system.
The new QIAcube Connect MDx version is compliant with medical device design standards and regulations and increases lab-process safety with a complete IVD system, which can also be used to prepare SARS-CoV-2 and other viral samples for diagnostic testing. The platform can be used with over 80 QIAGEN kits and more than 140 standard protocols and ensures full standardization of the purification of multiple sample types.
Researchers can be freed up from repetitive and costly manual processing by allowing laboratories to automate the first steps of molecular diagnostic workflows through the use of QIAGEN’s gold-standard spin column technologies for DNA, RNA and protein sample processing.
“Many labs are currently facing huge demand for testing, and an increasing complexity of sample types and protocols. Customer feedback on QIAcube Connect for life sciences applications has been overwhelmingly positive. Given that many processes in molecular diagnostics also require efficiency, automation and connectivity, it was a natural progression to develop this solutions for use in diagnostics as well,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “As we continue to systematically upgrade our sample technology automation, as with the QIAcube Connect MDx, the use of our gold-standard QIAGEN technologies will provide laboratories with the greatest confidence in the valuable insights they gain from biological samples.”
QIAcube Connect MDx fully automates the lysis, bind, wash and elute steps of the QIAGEN spin columns (which can also be used manually) for DNA, RNA and protein sample processing. This ensures streamlined processes, enhances reproducibility with less human error, and reduces hands-on time. Full connectivity allows lab technicians to stay connected with their instrument, which enables quick response times, protocol review and the ability to remotely monitor runs. The platform’s design is meant to ensure the highest safety standards for IVD labs and clinical researchers – with, for example, fully automated worktable decontamination built-in. Protocol controls and managed user access ensure data protection. Digital as well as barcode-enabled sample tracking and pre-run checks guarantee confidence in results.
The QIAcube Connect MDx can be connected to the QIAsphere digital platform to allow for real walk-away convenience. Lab workers can keep track of their instrument’s status using a remote monitoring feature on the QIAsphere App, respond to events faster by receiving push notifications, collaborate seamlessly, and maximize instrument use through workgroup/device management.
For more information about QIAcube Connect MDx platform, please visit our product page. Further information on QIAGEN’s response to the coronavirus outbreak can be found here.
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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of December 31, 2020, QIAGEN employed approximately 5,600 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, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; 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.