Oct. 7, 2024—Qiagen announced the launch of the QIAcuityDx digital PCR system, an IVD medical device that integrates partitioning, thermocycling, and imaging into a streamlined five-plex workflow in a single instrument. The nanoplate-based workflow disperses a sample into thousands of tiny partitions and then reads reactions simultaneously to quantify signals from DNA and RNA. QIAcuityDx software is designed for diagnostic use and features a comprehensive audit trail that is compliant with modern lab requirements. It includes an IVD mode, which offers validated assay plug-ins and automated analysis, and a utility mode, which provides flexibility to laboratories for their laboratory-developed tests and research applications.
The instrument and accessories are 510(k) exempt in the Unites States and IVDR certified for diagnostic use in Europe.