QIAGEN launches new QIAcuity digital PCR kits and updated software to expand use by biopharma and food safety customers

  • Three new QIAcuity kits enhance digital PCR applications in biopharma research and food safety, ensuring precise quantification, increased sensitivity and cost-efficiency
  • QIAcuity Software 2.5 update streamlines digital PCR analysis with precise run temperature and sample dilution information, critical to biotech and pharma reporting and auditing
  • Pipeline of new kits planned to expand application areas and foster digital PCR adoption

Venlo, the Netherlands — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of three new kits for use on its QIAcuity systems and a major new software update designed to expand the portfolio of applications for use of digital PCR technology in areas like cell and gene therapies, DNA and RNA quantification, as well as food and pharmaceuticals safety:

  • The QIAcuity Mycoplasma Quant Kit offers researchers an accurate and precise way to detect mycoplasma contaminants in all steps of research and manufacturing of cell and gene therapies. The kit offers a unique and sensitive workflow that has been validated by a third party and complies with the mycoplasma testing frameworks provided by the US, the EU and the Japanese Pharmacopeia, thus reducing validation effort in-house.
  • The QIAcuity OneStep Advanced EG Kit allows researchers the highly sensitive quantification of RNA or RNA alongside DNA in one reaction. The kit uses intercalating dye technology that makes procedures easier to design and more cost-efficient than those used in fluorescent-probe-based PCR. In contrast to other chemistry, the patent-pending HotStart RT enzyme is only active at higher temperatures, preventing uncontrolled reaction activity while plates are set up in the lab or waiting for cycling in the QIAcuity instrument. This allows reaction set-up at room temperature and leads to more reliable results in multi-plate workflows. QIAGEN’s OneStep and other innovative chemistry ensures a fast and easy workflow, with little hands-on time.
  • QIAcuity mericon Food Testing Kits are the only ready-to-use digital PCR food tests on the market. They enable researchers to fight product adulteration through target-specific authentication of food and animal-feed ingredients. The launch sees QIAGEN extending its large food-safety testing portfolio from traditional quantitative PCR, providing increased precision and sensitivity, as well as ensuring dependable data analysis and interpretation.

“The launch of our new QIAcuity kits and the software update emphasize QIAGEN’s dedication to advancing digital PCR analysis in crucial sectors like pharma, biopharma research, and food and drug safety,” said Nitin Sood, Senior Vice President and Head of the Life Sciences Business Area at QIAGEN. “By incorporating these innovations into our QIAcuity platform, we are reinforcing our commitment to providing precise, fast, scalable and easy-to-use digital PCR solutions for a wide range of applications.”

Additionally, QIAGEN plans to launch in November the QIAcuity Software 2.5 update. It is designed to help researchers determine two key features of digital PCR analyses. Using the functionality of a temperature gradient, the software will allow them to determine the precise temperature at which their experiment should run, saving the need to put the sample through an external thermocycler during the development of tests to target specific genetic building blocks.

As sample material is often diluted before being analyzed by digital PCR, the new software will also calculate the prevalence of the targeted material in a sample and any dilution required. After the test, QIAcuity Software 2.5 adjusts for dilution and converts the results into user-defined units, automating and documenting a demanding task crucial for pharmaceutical companies’ reports and audit trails.

QIAGEN’s digital PCR platform QIAcuity uses nanoplates to disperse a sample over thousands of tiny partitions and then read the reaction in each one simultaneously 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 highly versatile QIAcuity systems are available in one, four, and eight-plate versions, with the one-plate version processing up to 384 samples in an eight-hour shift and the eight-plate version up to 1,248 in the same time period.

Learn more about QIAGEN’s QIAcuity range of digital PCR kits and devices at https://www.qiagen.com/us/product-categories/discovery-and-translational-research/pcr-qpcr-dpcr/dpcr-assays-kits-and-instruments.

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, 2023, QIAGEN employed more than 6,000 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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