Thermo Fisher Scientific is offering an IVDR version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System globally. The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology. Molecular diagnostic kit manufacturers and clinical testing labs that develop their own assays need open qPCR platforms that meet IVDR requirements. The IVDR-compliant QuantStudio 5 Dx System will enable molecular diagnostic manufacturers to develop new IVDR-compliant tests under the new regulations. The system will also help clinical labs running diagnostic tests switch to IVDR qPCR testing. Among the system's updates, the multi-mode software is now IVDR compliant, providing dual functionality for running diagnostic tests and developing new assays in today's regulatory environment. The qPCR system comes with an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes. In addition, a security, auditing, e-signature module provides secure operation. The updated QuantStudio 5 Dx Real-Time PCR System is available in all regions that recognize CE-IVD certification and is also listed with the U.S. Food and Drug Administration (FDA).