Netherlands-based diagnostic firm QIAGEN has announced the launch of the QIAcuityDx Digital PCR System, a new addition to its digital PCR portfolio which is expanding into clinical diagnostics. The new system 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). The instrument and accessories are 510(k) exempt in the US and IVDR-certified for diagnostic use in Europe.
QIAGEN is rapidly expanding the application menu available on QIAcuityDx-System, with a new BCR::ABL assay for oncohaematology 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 laboratories 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, UK, 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 tumour is changing, how the molecular basis of that tumour 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 five-plex workflow within a single instrument, eliminating the need for additional equipment. Capable of processing up to four nanoplates simultaneously, it reduces laboratory space requirements, servicing needs, and operator time. Laboratories 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.
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 organisations and forensic laboratories. QIAcuityDx will now address additional customer segments, further strengthening the footprint of the QIAcuity family.
For more information on QIAcuityDx visit https://www.qiagen.com/de-us/products/instruments-and-automation/pcr-instruments/qiacuity-dx-mdx