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QIAGEN Expands Clinical Diagnostics with ARTG-Listed QIAcuityDx Digital PCR System

NextEdge Admin

27 Nov 2024

2 min 41 sec

digital PCR System,diagnostics,Next-Generation Sequencing,workflow

QIAGEN has announced the inclusion of the QIAcuityDx digital PCR System in the Australian Register of Therapeutic Goods (ARTG), marking a significant step in expanding digital PCR into clinical diagnostics. This IVDR-certified platform offers high-precision, absolute quantitation of DNA and RNA, making it ideal for oncology and infectious disease applications. It supports minimally invasive liquid biopsies, enabling cancer monitoring and complementing routine diagnoses like Next-Generation Sequencing (NGS).

The QIAcuityDx integrates partitioning, thermocycling, and imaging into a streamlined 5-plex workflow, reducing lab space, operator time, and cross-contamination risks. Capable of processing up to four nanoplates simultaneously, it delivers results in just two hours while maintaining high precision and sensitivity. The platform also offers continuous sample loading and flexible scheduling, supporting urgent testing without delays.

Designed for diagnostic use, QIAcuityDx features software with IVD and Utility modes, allowing labs to use validated assays or develop their own tests. It includes a bi-directional LIMS interface for seamless integration, QIAcuityDx-optimized consumables, and a validated installation process with audit-ready reporting. A 5-channel calibration ensures reproducibility and accuracy.

Looking ahead, QIAGEN plans to expand the QIAcuityDx menu, including a BCR::ABL assay for oncohematology by late 2025. Partnerships with pharmaceutical companies are advancing the development of companion diagnostics, driving innovation in precision medicine. Labs can also access QIAGEN’s full range of research products via GeneGlobe.

With over 2,000 QIAcuity placements globally and citations in 450+ publications, this launch extends the system’s reach to clinical labs. "QIAcuityDx allows regional labs to monitor cancer locally with an all-in-one system compliant with strict regulatory standards," said Piers Murray, QIAGEN’s Head of Sales for Australia & New Zealand.