QIAGEN Adds New Biopharma Products to QIAcuity Digital PCR Portfolio and Launches Expertly Customized Assay Design Service | news

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced several enhancements to its QIAcuity line of digital PCR (dPCR) instruments. The innovations aim to promote the use of the system, especially in the biopharmaceutical sector:

  • The new solutions include ten new QIAcuity Cell and Gene Therapy (CGT) dPCR assays to quantify AAV (adeno-associated virus) titers and three new QIAcuity Residual DNA Quantification Kits to analyze host cell DNA transmission.
  • A new version of the QIAcuity Software Suite includes enhanced features to support Good Manufacturing Practice (GMP) compliance.

The major expansion of QIAGEN’s dPCR assay offering follows the previous milestone of more than 1,000 cumulative placements of the QIAcuity system since its launch in late 2020. QIAcuity’s digital PCR technology is based on the use of nanoplates to perform faster than other systems. Division of samples. The instruments are available in versions with one, four and eight plates. They all combine partitioning, thermal cycling and image processing in a single workflow, reducing processing time from six to two hours.

“We tested the dPCR technology in QIAGEN’s QIAcuity system to quantify viral titers, vector copies and residual host cell DNA, all critical factors for in-line quality control in gene therapy. QIAcuity dPCR is easy to use, fast, scalable and GMP compliant. ” said Dana Cipriano, Senior Vice President, Testing and Analytical Services, at the Center for Breakthrough Medicines in King of Prussia, Pennsylvania, USA. “The system is a major extension of our analytical development and testing services as well as our process development and R&D platforms and is available to our customers immediately.”

“The new cell and gene therapy applications increase the value of QIAcuity for biopharma customers by addressing their needs for high-throughput analytical methods, rapid turnaround times, wet-lab-tested catalog assays and multiplexing, among other things,” said Thomas Schweins, Senior Vice President and Head of Life Sciences at QIAGEN. “Our custom dPCR assays build on decades of experience in test design for traditional qPCR. The Expert Custom Assay Design Service now expands customer choice beyond the existing assay catalog, particularly in key application areas requiring simultaneous detection of up to five molecular markers.”

Biopharma customers will benefit from the introduction of ten wet-lab validated QIAcuity cell and gene therapy (CGT) assays developed with a variety of fluorophores that can provide fast, more accurate and more reproducible results with a dynamic range of at least four orders. size.

QIAcuity Residual DNA Quantification Kits are also targeted at the biopharmaceutical industry. They can be used to isolate residual host cell DNA (resDNA) from CHO, E coli and detect HEK293 cells used in cell and gene therapy. This is possible even if the sample contains PCR contamination and other inhibiting reagents. These three new kits are used in conjunction with the new QIAcuity UCP Probe PCR Kit, which uses an ultra-pure master mix to minimize background contaminating DNA and enable detection of residual DNA, among other quality control applications.

Together with the updated QIAcuity Software Suite, biopharmaceutical customers can benefit from an out-of-the-box workflow for the development and manufacture of cell and gene therapies. Version 2.1 of the software offers, among other things, customer-specific user management with individually adapted authorizations, improved management of the records, an electronic signature for reports (to meet the requirements of FDA 21 CFR, Part 11), an audit trail status display and robust cyber security.

The menu expansion is complemented by the introduction of the Expert Custom Assay Design Service, which will be available worldwide from the end of July. Through the service, dPCR users can obtain customized multiplex assays that can be used to detect various pathogens and rare mutations, as well as copy number variations and other molecular phenomena. A reduced time consumption from design freezing to delivery of the test in just two weeks saves time and money for the customer. Customers can access, manage and order their tests accordingly through QIAGEN’s GeneGlobe design and analysis portal. In addition, they have access to the QIAGEN Genomic Services team for verification of the tests in the wet lab.

Biopharma customers developing next-generation therapies are increasingly turning to dPCR to improve drug safety and efficacy. Compared to qPCR, dPCR technology is much more sensitive and accurate. Therefore, it can be used for numerous applications in drug development from drug discovery to clinical trials to manufacturing. According to the latest market research reports, the market for dPCR in the biopharmaceutical industry is currently growing at a solid double-digit rate and is expected to become a multi-billion dollar market in the coming years.

For more information, see https://www.qiagen.com/applications/pharma-biotech/applications/cell-and-gene-therapy


QIAGEN NV, a Dutch holding company, is the world’s leading supplier of complete solutions for obtaining valuable molecular insights from biological samples. QIAGEN sample technologies enable the purification and processing of DNA, RNA and proteins from blood, tissue and other materials. Testing technologies make these biomolecules visible and ready for analysis. Bioinformatics solutions and knowledge bases help interpret data to obtain relevant and actionable insights. Automation solutions integrate these into seamless and cost-effective molecular testing workflows. QIAGEN provides its solutions to more than 500,000 customers in molecular diagnostics (healthcare) and life sciences (academic research, pharmacological research and development and industrial applications, primarily forensics). Per As of March 31, 2022, QIAGEN employed more than 6,000 people in over 35 locations worldwide. For more information about QIAGEN, visit http://www.qiagen.com.

Forward-looking statement

Some of the statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the US Securities Act of 1933, as amended, and Section 21E of the US Securities Exchange Act of 1934, as amended -looking statements”) apply. To the extent this release contains forward-looking statements about QIAGEN’s products, including those used in response to the COVID-19 pandemic, timeline of launches and developments, regulatory approvals, financial and operational projections, growth, expansions, collaborations, markets, strategy or operational results; including, but not limited to, projected results for adjusted net sales and adjusted diluted earnings per share, based on current expectations and assumptions, which involve a number of uncertainties and risks.These include, but are not limited to: risks associated with managing growth and international operations (including the impact of currency fluctuations and dependence on regulatory etc g logistic processes); fluctuations in operating results and their distribution among our customer groups; developing markets for our products for customers in academic research, pharmaceuticals, applied testing and molecular diagnostics; Changing relationships with customers, suppliers and strategic partners, the competitive environment, rapid or unexpected technological changes, fluctuations in the demand for QIAGEN products (including general economic developments, the size and availability of our customers’ budgets and other factors), the ability to obtain regulatory approval of our products, difficulties in adapting QIAGEN’s products into integrated solutions and manufacturing such products, the company’s ability to develop and implement new product ideas and to differentiate and protect against competitors’ products, market acceptance of new products and integration of acquired businesses and technologies; actions by governments; global or regional economic development; delays caused by weather or transportation, natural disasters, political or public health crises, including the extent and duration of the COVID-19 pandemic and its impact on demand for our products and other aspects of our business, or other events of a higher level of Force; and the possibility that anticipated benefits associated with recent or pending acquisitions may not materialize as anticipated; and other factors discussed under “Risk Factors” in Section 3 of the current Annual Report Form 20-F. For more information, see QIAGEN’s filings with the US Securities and Exchange Commission.


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