Qiagen has launched its new QIAcuityDx Digital PCR System for clinical oncology testing, expanding its digital polymerase chain reaction (PCR) portfolio and entering the clinical testing space in North America and the European Union (EU).
The QIAcuityDx Digital PCR System and its accessories are U.S. Food and Drug Administration (FDA) 510(k) exempt in the U.S. and certified for diagnostic use under the In Vitro Diagnostic Regulation (IVDR) in the EU.
The platform integrates partitioning, thermocycling, and imaging into an all-in-one instrument, which aims to reduce costs and improve efficiency, Qiagen said in a statement. Qiagen's nanoplate-based workflow disperses a sample into thousands of partitions and then reads reactions simultaneously to quantify even faint DNA and RNA signals. The new system is capable of processing up to four nanoplates simultaneously, Qiagen added.
"With the QIAcuityDx, we are bringing our precise and efficient digital PCR platform into the clinical space, reflecting our commitment to meeting the evolving needs of clinical labs in monitoring and minimal residual disease testing during patient treatment," Fernando Beils, senior vice president and head of molecular diagnostics at Qiagen, said.
"By integrating all necessary functions into a single device, we are simplifying workflows and reducing operational costs for clinical labs, while instilling confidence in highly accurate and reliable diagnostic results," Beils added.
The platform provides access to Qiagen's full portfolio of research-use products and applications via the GeneGlobe platform; additionally, Qiagen is expanding the application menu available for the QIAcuityDx system, with a new oncohematology assay planned for FDA submission in 2025.
