Qiagen Launches QIAcuityDx Digital PCR System for Clinical Diagnostics

QIAcuityDx is designed to deliver precise, absolute quantitation of target DNA and RNA, making it an essential tool for liquid biopsy applications and cancer progression monitoring.

Qiagen NV, the Netherlands-based global leader in molecular testing solutions, has announced the launch of the QIAcuityDx Digital PCR System, an advanced addition to its digital PCR portfolio that expands the company’s presence into clinical diagnostics.

The system is 510(k) exempt in the United States and IVDR-certified for diagnostic use in Europe, positioning it as a key player in precision medicine.

QIAcuityDx is designed to deliver precise, absolute quantitation of target DNA and RNA, making it an essential tool for liquid biopsy applications and cancer progression monitoring.

Unlike traditional approaches that require more invasive tissue biopsies, the QIAcuityDx system supports non-invasive testing methods, enabling healthcare providers to track disease progression with greater ease and accuracy.

QIAcuityDx Supporting Cancer Monitoring

This system complements routine cancer diagnoses, often performed using Next-Generation Sequencing (NGS), by offering a faster and more cost-effective method for minimal residual disease (MRD) testing.

With liquid biopsies gaining traction as a less invasive alternative to traditional biopsy methods, QIAcuityDx has the potential to revolutionize the way cancer is monitored and managed.

Qiagen is actively expanding its application portfolio for the QIAcuityDx system, with a BCR::ABL assay planned for FDA submission in 2025 to target oncohematology applications.

The platform also provides instant access to Qiagen’s GeneGlobe platform, offering a wide range of research-use products and applications.

Additionally, the company has partnered with three pharmaceutical companies to develop companion diagnostics for the QIAcuityDx, aiming to further embed digital PCR in the growing field of precision medicine.

Qiagen is also looking to enhance the QIAcuityDx platform’s future offerings by collaborating with third-party developers, who will create their assays to extend the system's capabilities even further.

Fernando Beils, senior vice president and head of Qiagen’s molecular diagnostics business, said “The QIAcuityDx system simplifies workflows and reduces operational costs for clinical labs, providing highly accurate and reliable diagnostic results. We are committed to meeting the evolving needs of clinical labs in monitoring and minimal residual disease testing during patient treatment.”

The QIAcuityDx system boasts a compact benchtop design, ensuring minimal space is required in busy clinical labs.

The device integrates partitioning, thermocycling, and imaging in a single unit, enabling 5-plex workflows without the need for additional equipment.

With the capability to process up to four nanoplates simultaneously, the system maximizes efficiency by reducing operator time and lab space requirements.

QIAcuityDx system's Partitioning Technology

The QIAcuityDx system's partitioning technology disperses a sample into thousands of partitions, allowing for precise detection of even faint signals from DNA and RNA.

With a processing time of just two hours, the system significantly reduces diagnostic turnaround times while minimizing the risk of cross-contamination.

QIAcuityDx's software offers a user-friendly interface with two modes: a validated IVD mode for routine diagnostic assays and a Utility Mode for more customized laboratory-developed tests (LDTs) and research applications.

This flexibility ensures the system can meet diverse clinical needs while adhering to stringent regulatory requirements.

Moreover, the system supports continuous sample loading and flexible scheduling, allowing labs to accommodate urgent testing without delaying other patient results.

This is particularly valuable in clinical settings where rapid diagnostic feedback is critical to patient care.

Seamless Integration & Regulatory Compliance

To ensure smooth integration into clinical environments, QIAcuityDx includes a bi-directional LIMS (Laboratory Information Management System) interface for seamless connection with electronic patient records.

The system also comes with a validated installation process that meets regulatory standards, helping labs maintain compliance with industry requirements.

The platform also features a 5-channel calibration system that enhances image processing and ensures reliable, reproducible results across a range of clinical applications.

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