QIAGEN launches QIAcuityDx digital PCR system for clinical testing in oncology

Rhea-AI Summary

QIAGEN has launched the QIAcuityDx Digital PCR System, expanding its digital PCR portfolio into clinical diagnostics. The system is 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe. It provides precise, absolute quantitation of target DNA and RNA, supporting liquid biopsy applications and cancer monitoring.

Key features of QIAcuityDx include:

• All-in-one instrument for IVD assays and lab-designed tests
• User-friendly software with IVD and Utility modes
• Flexible scheduling and continuous sample loading
• Processing of up to four nanoplates simultaneously
• Reduced lab space requirements and processing times

QIAGEN plans to expand the application menu, with a BCR::ABL assay for oncohematology planned for FDA submission in 2025. The company has also signed three partnerships for companion diagnostics development.

Positive

• Expansion into clinical diagnostics market with 510(k) exempt and IVDR-certified system
• Partnerships with three pharmaceutical companies for companion diagnostics development
• Planned FDA submission for BCR::ABL assay in 2025
• Strong adoption of QIAcuity research instrument with over 2,000 cumulative placements by end of 2023
• Citations in over 450 publications for QIAcuity digital PCR research instrument

Negative

• None.

Insights

Medical Research Analyst

The launch of QIAcuityDx Digital PCR System marks a significant advancement in clinical diagnostics, particularly for oncology. This system offers absolute quantitation of DNA and RNA targets, which is important for monitoring low-abundance biomarkers in cancer progression. The technology's ability to work with liquid biopsies is a key advantage, potentially reducing the need for invasive procedures.

The system's 5-plex workflow and integration of multiple processes into a single instrument streamline laboratory operations, potentially reducing costs and improving efficiency. The planned BCR::ABL assay for oncohematology, slated for FDA submission in 2025, could be particularly impactful for leukemia monitoring.

QIAGEN's partnerships for companion diagnostics development suggest a strong move towards precision medicine. This could lead to more targeted therapies and improved patient outcomes in oncology. The system's flexibility in supporting both IVD assays and laboratory-developed tests (LDTs) provides versatility for clinical labs, potentially accelerating adoption.

However, the true impact will depend on the expansion of the assay menu and successful regulatory approvals. The 10 billion market cap of QIAGEN suggests it has the resources to support this expansion, but competition in the digital PCR space is intense.

Expands range of applications for successful QIAcuity digital PCR platforms, now entering the clinical space across North America and the EU // Provides absolute quantitation, essential for precise monitoring of low-abundance targets in clinical diagnostics // Enhances lab efficiency and reduces costs with all-in-one instrument for either IVD assays or tests designed and used by laboratories, user-friendly software and flexible scheduling features

Venlo, the Netherlands, Sept. 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAcuityDx Digital PCR System, a pivotal addition to its digital PCR portfolio now expanding into clinical diagnostics. The instrument and accessories are 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe.

QIAcuityDx streamlines clinical testing by providing highly precise, absolute quantitation of target DNA and RNA, supporting applications with less invasive liquid biopsies. These capabilities make it an ideal tool for monitoring cancer progression, complementing routine cancer diagnoses, which are typically performed using Next Generation Sequencing (NGS).

QIAGEN is rapidly expanding the application menu available on QIAcuityDx-System, with a new BCR::ABL assay for oncohematology planned for FDA submission in 2025. The platform also provides immediate access to QIAGEN’s full portfolio of research-use products and applications via its GeneGlobe platform. QIAGEN has already signed three partnerships with pharmaceutical companies to develop companion diagnostics on the QIAcuityDx, moving digital PCR into precision medicine. In addition, QIAGEN plans to further enhance the future assay portfolio by collaborating with third parties, who will develop their own assays for the platform.

“With the QIAcuityDx, we are bringing our precise and efficient digital PCR platform into the clinical space, reflecting our commitment to meeting the evolving needs of clinical labs in monitoring and minimal residual disease testing during patient treatment,” said Fernando Beils, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. “By integrating all necessary functions into a single device, we are simplifying workflows and reducing operational costs for clinical labs, while instilling confidence in highly accurate and reliable diagnostic results.”

“The QIAcuityDx is a compact benchtop technology that doesn't take up much space and is very easy to use. The run is short, so you get results really fast. It provides a report that is digestible, translatable, and meaningful, and makes it easy to make decisions,” said Dr. Kate Brown, translational research manager at The Christie NHS Trust in Manchester, United Kingdom, when asked about the clinical implications of QIAcuityDx for patients. Dr. Brown has used QIAcuityDx as part of a collaborative lung cancer study with QIAGEN.

“It enables us to improve the testing workflow. It allows us to quantify what's happening, to gain true insight into how the tumor is changing, how the molecular basis of that tumor is responding to treatment. And that is something that other existing technologies are unable to offer,” she added.

The QIAcuityDx platform is an IVD medical device that integrates partitioning, thermocycling, and imaging into a streamlined 5-plex workflow within a single instrument, eliminating the need for additional equipment. Capable of processing up to four nanoplates simultaneously, it reduces lab space requirements, servicing needs, and operator time. Labs familiar with QIAcuity can expect the same easy and fast nanoplate-based workflow, which disperses a sample into thousands of tiny partitions and then reads reactions simultaneously to quantify even the faintest signals from DNA and RNA.

QIAcuityDx’s technology enables higher throughput, allows for imaging of partitions, improves precision and sensitivity, cuts processing times to just two hours, and reduces the risk of cross-contamination – crucial factors for applications like oncology and infectious diseases.

QIAcuityDx software is designed for diagnostic use, featuring a user-friendly interface and comprehensive audit trail compliant with modern lab requirements. It includes two modes:

• An IVD mode offering validated assay plug-ins and automated analysis.

• A Utility Mode, providing flexibility to laboratories for their laboratory-developed tests (LDTs) and research applications.

The QIAcuity-DX platform supports continuous sample loading and flexible scheduling, accommodating urgent testing needs without compromising patient results. To ensure diagnostic compliance and meet clinical customer needs, QIAcuityDx will include: 

• A bi-directional LIMS (Laboratory Information Management System) interface for seamless integration with electronic patient records.
• QIAcuityDx-optimized universal master mix and nanoplates manufactured under strict regulatory standards.
• A validated installation process supporting lab compliance with an audit-ready report.
• 5-channel calibration enhancing image processing and reproducibility.

The adoption of QIAcuity digital PCR research instrument is strong, with more than 2,000 cumulative placements at the end of 2023 and citations in over 450 publications. Key customers include pharmaceutical and biotechnology companies, academic and research organizations and forensic laboratories. QIAcuityDx will now address additional customer segments, further strengthening the footprint of the QIAcuity family.

For more information on QIAcuityDx and to enhance your lab’s diagnostic capabilities, visit https://www.qiagen.com/de-us/products/instruments-and-automation/pcr-instruments/qiacuity-dx-mdx

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 June 30, 2024, QIAGEN employed more than 5,900 people in over 35 locations worldwide. Further information can be found at https://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, 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, 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 in 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.

Source: QIAGEN N.V.
Category: Corporate

FAQ

What is the QIAcuityDx Digital PCR System launched by QIAGEN (QGEN)?

The QIAcuityDx Digital PCR System is QIAGEN's new clinical diagnostic platform that provides precise, absolute quantitation of target DNA and RNA. It's designed for applications like cancer monitoring and liquid biopsies, and is 510(k) exempt in the U.S. and IVDR-certified in Europe.

When is QIAGEN (QGEN) planning to submit the BCR::ABL assay for FDA approval?

QIAGEN is planning to submit the BCR::ABL assay for oncohematology for FDA approval in 2025.

How many partnerships has QIAGEN (QGEN) signed for companion diagnostics on QIAcuityDx?

QIAGEN has signed three partnerships with pharmaceutical companies to develop companion diagnostics on the QIAcuityDx platform.

What are the key features of QIAGEN's (QGEN) QIAcuityDx Digital PCR System?

Key features include an all-in-one instrument for IVD assays and lab-designed tests, user-friendly software with IVD and Utility modes, flexible scheduling, continuous sample loading, processing of up to four nanoplates simultaneously, and reduced lab space requirements and processing times.