USA – QIAGEN has launched the QIAcuityDx Digital PCR System, a next-generation device designed to transform clinical cancer diagnostics and monitoring.
The 510(k) exempt and IVDR-certified platform brings precision to DNA and RNA quantification, empowering clinicians to perform rapid, non-invasive cancer tests.
This new system promises to enhance liquid biopsy applications, allowing clinicians to track cancer progression with greater accuracy than traditional methods.
Fernando Beils, Senior VP and Head of QIAGEN’s Molecular Diagnostics, explained, “With the QIAcuityDx, we’re meeting the critical need in clinical labs for streamlined, reliable testing for monitoring and minimal residual disease during treatment.
“By integrating all necessary functions, we simplify workflows and reduce operational costs, all while ensuring accurate diagnostic results.“
Streamlined workflow enhances efficiency
QIAcuityDx is designed for efficiency, incorporating a 5-plex workflow that combines critical testing stages within a single instrument.
With the capability to process up to four nanoplates simultaneously, the system reduces lab space requirements, operator time, and processing duration—delivering results within two hours.
The QIAcuityDx system supports diverse laboratory needs by offering two distinct operational modes.
The IVD Mode provides pre-validated assays with automated analysis, streamlining clinical diagnostics for greater efficiency.
Meanwhile, the Utility Mode offers flexibility, enabling labs to conduct customized lab-developed tests and research applications, catering to both standardized and exploratory diagnostic approaches.
Additionally, the platform includes a LIMS (Laboratory Information Management System) interface to seamlessly integrate patient data and facilitate compliance with diagnostic standards.
To further enhance performance, QIAcuityDx’s calibrated five-channel imaging enhances precision for oncology and infectious disease applications.
“QIAcuityDx is compact, easy to use, and provides rapid, digestible reports that simplify decision-making in cancer care,” noted Kate Brown, PhD, Translational Research Manager at The Christie NHS Trust, who collaborated with QIAGEN on a lung cancer study.
Advanced digital PCR for precision medicine
A vital addition to QIAGEN’s digital PCR offerings, QIAcuityDx supports applications that benefit from sensitive DNA/RNA detection, including oncology and infectious diseases.
This platform allows for continuous sample loading, flexible scheduling, and higher throughput, making it ideal for hospitals and labs with urgent testing needs.
QIAGEN is rapidly expanding its assay offerings for the QIAcuityDx system. The company is developing a BCR::ABL test for hematologic oncology, anticipated for FDA submission in 2025.
QIAcuityDx also supports QIAGEN’s research-use products via the GeneGlobe platform, while partnerships with pharmaceutical companies are underway to develop companion diagnostics, positioning digital PCR as a key player in precision medicine.
Digital PCR’s role in cancer diagnostics aligns with the projected growth in the global oncology clinical trials market, which was valued at US $12.92 billion in 2022 and is expected to grow annually by 5.2% through 2030.
QIAcuityDx positions QIAGEN at the forefront of this trend, enhancing its global footprint with over 2,000 placements in 2023 alone.
“Our goal is to support precision medicine advancements by collaborating with pharmaceutical partners to develop companion diagnostics on the QIAcuityDx platform,” stated Beils, as QIAGEN continues to expand its assay portfolio.
