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Press Release

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QIAGEN expands range of digital PCR kits and services for the biopharma industry

July 18, 2023
  • New partnership with Niba Labs to offer customized digital PCR (dPCR) assay design services to biopharma customers
  • Launch of CGT Viral Vector Lysis Kit enabling standardized workflow from cell lysates to absolute and precise quantification of viral titers
  • Biopharmaceutical companies increasingly adopting dPCR technology for enhanced drug safety and efficacy in drug development process

Venlo, the Netherlands, July 18, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today the expansion of its digital PCR (dPCR) offering for the development of cell and gene therapies in the biopharma industry.

The company has partnered with Niba Labs to offer customized digital PCR assay design services to biopharma customers and also launched the new CGT Viral Vector Lysis Kit that enables a standardized workflow from cell lysates to absolute and precise quantification of viral titers for multiple serotypes.

The partnership between QIAGEN and Niba Labs, an analytical laboratory with extensive expertise in digital PCR assay development and sample testing, will allow QIAcuity customers to use the combined expertise of both companies to develop new custom simplex or multiplex assays for the quantification of nucleic acids and to optimize existing qPCR assays for the use in digital PCR. Niba Labs will evaluate the performance of the assays and validate them within Good Manufacturing Practice (GMP). With their combined products and services, QIAGEN and Niba Labs can help cell and gene therapy developers to overcome potential resource constraints and meet demanding project timelines.

“QIAGEN is committed to providing innovative solutions that meet the evolving needs of the biopharma industry,” said Michael Scheffler, Vice President, Head of Life Sciences PCR business at QIAGEN. “We have recently expanded our digital PCR portfolio, adding new assays and kits for cell and gene therapy applications for the QIAcuity. Our partnership with Niba Labs will help us to further strengthen our biopharma offering and provide customers with customized solutions that address their unique challenges.”

“Niba Labs is committed to developing innovative analytical solutions for the biopharma industry focused on cell and gene therapies, thoroughly investigating quality attributes such as vector genome titer and genome integrity,” said David Dobnik, PhD, Chief Scientific Officer at Niba Labs. “We have addressed the issue of AAV vector genome integrity by developing an advanced dPCR multiplex approach. We trust that our partnership with QIAGEN will provide the biopharma industry with most advanced analytical solutions to meet the evolving industry requirements and further advance their cell and gene therapy products.”

The new CGT Viral Vector Lysis Kit launched for the QIAcuity digital PCR instrument adds to QIAGEN’s rapidly growing digital PCR portfolio for the biopharma industry that includes ten QIAcuity Cell and Gene Therapy (CGT) dPCR Assays for use in adeno-associated virus (AAV) titer quantification and three QIAcuity Residual DNA Quantification Kits for checking carryover of host cell DNA. The new kit provides high repeatability and is capable of determining viral genome titers in single- and multiplex reactions, as well as quantification over a broad dynamic range with high accuracy when combined with the QIAcuity CGT dPCR Assays, making it ideal for drug development and quality control in manufacturing.

“With the introduction of our CGT Viral Vector Lysis Kit, we aim to provide a streamlined protocol for AAV lysis that will bring standardization to bioprocessing workflows and enhance Standard Operating Procedures, quality control and safety. In conjunction with our QIAcuity CGT assays, this kit allows for vector genome titration with remarkable accuracy, repeatability and robustness compared to current workflows,” stated Scheffler.

Biopharmaceutical customers developing next-generation therapies are increasingly adopting dPCR to enhance drug safety and efficacy. Compared to qPCR, dPCR technology provides a much higher level of sensitivity and accuracy that can be leveraged for multiple applications in the drug development process – from drug discovery and clinical trials to manufacturing.

QIAGEN’s digital PCR platform QIAcuity is based on using nanoplates dispersing a sample over thousands of tiny partitions and then simultaneously reading the reaction in each one, enabling it to quantify even the faintest signals from DNA and RNA. The instruments integrate partitioning, thermocycling, and imaging into one workflow, cutting processing times to only two hours from six. The QIAcuity system is available in one, four, and eight-plate versions – with the four-plate version processing up to 500 samples in an eight-hour shift and the eight-plate version processing more than 850 samples in that time frame.

More information on cell and gene therapy with digital PCR can be found here: https://www.qiagen.com/applications/pharma-biotech/applications/cell-and-gene-therapy

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 March 31, 2023, 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, 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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