• 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 

QIAGEN announced the inclusion of the QIAcuityDx digital PCR System in the Australian Register of Therapeutic Goods (ARTG). This pivotal addition to QIAGEN’s portfolio is now expanding digital PCR into clinical diagnostics, enabling labs to harness its precision and efficiency for applications in oncology and infectious diseases. The instrument and accessories are IVDR-certified. 

QIAcuityDx can streamline clinical oncology 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 and complementing routine cancer diagnoses, which are  typically performed using Next Generation Sequencing (NGS).  

QIAGEN plans to expand the menu on the QIAcuityDx-System with a new BCR::ABL assay for  oncohaematology in late 2025. The platform offers immediate access to QIAGEN’s full range of research use products via GeneGlobe. Additionally, QIAGEN has partnered with three pharmaceutical companies to  develop companion diagnostics on QIAcuityDx, advancing digital PCR into precision medicine. Future  assay developments will include collaborations with third parties creating their own assays for the platform. 

“QIAcuityDx allows our users in infectious diseases and clinical oncology to have access to an all-in-one digital PCR system that uses consumables that comply with strict regulatory standards. Our goal is to  give regional laboratories the flexibility to monitor cancer patients locally,” said Piers Murray, Head of  Sales for Australia & New Zealand at QIAGEN. 

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.