QIAGEN Launches artus Prep&Amp as CE-Marked SARS-CoV-2 Test Offering up to Threefold Increase in Daily Lab Testing Capacity

• QIAGEN’s innovative Prep&Amp technology integrates sample preparation and detection in a single kit, enabling throughput of more than 670 tests per PCR cycler in an eight-hour shift
• CE-IVD marking for Europe and other countries worldwide, EUA (Emergency Use Application) submission made in the U.S.
• Streamlined workflow cuts costs and plastic usage – offering time to result of about two hours

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the artus® SARS-CoV-2 Prep&Amp UM Kit which uses a liquid based sample preparation technology to simplify and increase COVID-19 testing throughput. The artus® SARS-CoV-2 Prep&Amp UM Kit has been CE-IVD registered for use in the European Union and other markets and an application for Emergency Use Authorization (EUA) has been submitted to the FDA, allowing commercialization via notification in the US.

QIAGEN’s innovative artus® SARS-CoV-2 Prep&Amp UM Kit integrates a liquid-based sample preparation that takes no more than two minutes with the provided real-time PCR assay. The kit uses common transport media like Universal Transport Media (UTM™) as the starting material, and provide all reagents required for sample to result on suspected SARS-CoV-2 patient samples.

The streamlined workflow delivers results considerably faster than standard extraction-based Real-Time PCR processes – and can support up to 672 samples per cycler in an eight-hour shift. Additionally, due to the short workflow the quantity and volume of waste created is considerably lower.

The artus® SARS-CoV-2 Prep&Amp UM Kit is based on the same technology that was launched in October 2020 as QIAprep&amp for research applications. It has since proved its ability to detect the SARS-CoV-2 pathogen to be similar to regular PCR workflows.

“The launch of our artus® SARS-CoV-2 Prep&Amp test is an important step as it expands our portfolio of testing solutions for COVID-19,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “We continue to see the need for a large volume of PCR tests as COVID-19 cases continue around the world – and our novel technology will enable clinical labs to drastically increase testing capacity with existing infrastructure. It is also an exciting and versatile technology with additional potential applications.”

QIAGEN has one of the most comprehensive SARS-CoV-2 research and testing portfolios. It includes sample preparation innovations like artus® SARS-CoV-2 Prep&Amp, syndromic testing solution QIAstat-Dx, high throughput PCR with its NeuMoDx devices, QIAcuity digital PCR for wastewater testing applications, QIAreach digital antibody and antigen tests, and T-cell research solutions based on QIAGEN’s QuantiFERON IGRA technology. QIAGEN also has a range of products for NGS research into the SARS-CoV-2 virus and bioinformatic services and databases such as QDI (QIAGEN Digital Insights).

QIAGEN continues to add novel solutions to support laboratories combatting the pandemic and to provide experts with tools to learn more about the virus and drive forward research – as well as providing solutions that will be relevant beyond the current pandemic.

More information on artus® SARS-CoV-2 Prep&Amp UM Kit can be found here.

For an overview of QIAGEN’s coronavirus testing solutions, please visit http://www.qiagen.com/coronavirus.

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.

Category: Corporate

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