Clinical Digital PCR System for Oncology Testing Delivers Highly Accurate Diagnostic Results

QIAGEN N.V. (Venlo, the Netherlands) has launched the QIAcuityDx Digital PCR System, a key addition to its digital PCR portfolio now geared toward clinical diagnostics. QIAcuityDx simplifies clinical testing by delivering highly accurate, absolute quantification of target DNA and RNA, making it ideal for applications such as monitoring cancer progression and complementing routine cancer diagnostics, which are typically performed using Next Generation Sequencing (NGS).

The QIAcuityDx platform is an IVD medical device that integrates partitioning, thermocycling, and imaging into a seamless 5-plex workflow within a single instrument, eliminating the need for extra equipment. Capable of processing up to four nanoplates simultaneously, it reduces laboratory space requirements, servicing demands, and operator time. Labs already familiar with QIAcuity will find the same fast and simple nanoplate-based workflow, where samples are partitioned into thousands of tiny sections and reactions are read simultaneously to detect even faint DNA and RNA signals. The QIAcuityDx system offers higher throughput, enables partition imaging, enhances precision and sensitivity, cuts processing time to just two hours, and reduces the risk of cross-contamination—essential for oncology and infectious disease applications.

The QIAcuityDx software is tailored for diagnostic use, offering an intuitive interface and a comprehensive audit trail to meet modern laboratory standards. It features an IVD mode with validated assay plug-ins and automated analysis, alongside a utility mode that provides flexibility for laboratories developing their own tests (LDTs) and research applications. The system supports continuous sample loading and flexible scheduling, allowing for urgent testing without compromising patient results. To ensure diagnostic compliance, QIAcuityDx includes a bi-directional LIMS (Laboratory Information Management System) interface for seamless integration with electronic patient records. It also comes with QIAcuityDx-optimized universal master mix, nanoplates manufactured under strict regulatory standards, a validated installation process with audit-ready reports, and 5-channel calibration to improve image processing and reproducibility.

QIAGEN is rapidly expanding the QIAcuityDx System’s application menu, with a BCR::ABL assay for oncohematology set for FDA submission in 2025. The platform also provides access to QIAGEN’s full range of research-use products via its GeneGlobe platform. Additionally, QIAGEN has partnered with three pharmaceutical companies to develop companion diagnostics on the QIAcuityDx, advancing digital PCR’s role in precision medicine. Looking ahead, QIAGEN plans to collaborate with third parties to develop new assays for the platform. The QIAcuityDx instrument and its accessories are 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe.

“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.”

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