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Press Release

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QIAGEN adds dPCR platform QIAcuity to growing portfolio of COVID-19 testing solutions for wastewater and mutation testing

January 28, 2021

• Digital PCR for COVID-19 wastewater testing overcomes limitations of traditional PCR
• Wastewater surveillance testing can quantify COVID-19 in populations and track mutations
• Custom QIAcuity One-Step Viral RT-PCR Kit supports wastewater testing applications

Germantown, Maryland, and Hilden, Germany, January 28, 2021 – QIAGEN today announced the addition of kits for wastewater testing to its growing portfolio of COVID-19 products. The use of dPCR in the worldwide surveillance of COVID-19 is an additional step towards making digital PCR (dPCR) an affordable and standard instrument for a host of applications in molecular-testing laboratories worldwide.

The new kits are designed for use on the uniquely fast and easy-to-use series of QIAcuity instruments based on digital polymerase chain reaction (dPCR) technology. QIAcuity precisely quantifies even minimal quantities of DNA and RNA in research tests for viruses, bacteria or genetic disorders, including the rarest of cancer mutations.

The precision of QIAcuity provides a valuable tool for use in testing wastewater for SARS-CoV-2. The application offers a cost-effective way to survey transmission dynamics of entire communities, avoiding the biases of other epidemiological indicators like deaths as a proportion of known cases or of the total population.

"In a trial run with the new high-throughput QIAcuity Eight, we were able to successfully detect new variants of SARS-CoV-2 in wastewater samples," said Dr. Franz Durandet, President of I.A.G.E. in Montpellier, France. "Our tests have proven that this fast and scalable technology from QIAGEN can provide a valuable addition to our environmental biological testing services, which we will offer to our clients in the near future."

COVID-19 surveillance through wastewater testing allows public authorities to collect data from broad sweeps of the population, including people who do not feature in public-health statistics because they lack access to healthcare. Potentially, surveillance testing can reveal infection and mutation dynamics earlier than diagnostic testing, providing public-health officials with near-real-time information on disease prevalence.

“We are proud that QIAcuity is proving its worth to customers as a cost-effective, highly reliable way to gain faster, easier access to digital PCR,” said Thomas Schweins, Senior Vice President, Head of the Life Science Business Area at QIAGEN. “We are seeing strong demand for QIAcuity from life-sciences laboratories in a wide range of fields. Our aim is eventually to create a clinical dPCR platform that will extend this powerful technology to every research and clinical lab worldwide. Our view is that about half of all traditional PCR applications could move to dPCR in the longer term.”

QIAcuity harnesses the greater accuracy of digital PCR over traditional quantitative real-time PCR while taking a quantum leap over the cumbersome methods of existing dPCR devices. QIAcuity uses nanoplate technology to disperse a sample over thousands of partitions and then simultaneously read the reaction in each one. Samples can be prepared and analyzed in two hours rather than six.

QIAcuity is available in three versions – the QIAcuity One (one plate), Four (four plates) and Eight (eight plates). Key features and benefits include fully automated workflow with a flexible sample throughput, a scalable format of one-, four- and eight-plate instruments, and the ability to simultaneously detect up to five target sequences. This allows the largest machine, QIAcuity Eight, to process up to 1,248 samples in one working day. 

QIAGEN is the only company to offer fast single-plex and multiplex PCR tests as well as a fast syndromic solution (QIAstat-Dx), providing a broad variety of PCR-based testing options. Its portfolio includes RNA extraction kits and instruments, and testing components and enzymes used by third parties for their PCR test kits. In August 2020, it also launched the QIAseq SARS-CoV-2 Primer Panel to help coronavirus researchers convert viral RNA samples into so-called libraries ready for decoding using high-throughput next generation sequencing (NGS) on Illumina platforms. The  QIAcuity One-Step Viral RT-PCR Kit opens up digital PCR for COVID-19 testing applications as well.

To learn more about QIAGEN digital PCR and the QIAcuity, please visit www.qiagen.com/dPCR.

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 September 30, 2020, QIAGEN employed approximately 5,300 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.

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