QIAGEN launches QIAcuityDx digital PCR system for clinical testing in oncology

QIAGEN N.V. has launched the QIAcuityDx Digital PCR System, a pivotal addition to its digital PCR portfolio now expanding into clinical diagnostics. The instrument and accessories are 510(k) exempt in the US and IVDR-certified for diagnostic use in Europe.

QIAcuityDx streamlines clinical 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, complementing routine cancer diagnoses, 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 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.

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