Tuesday, September 13, 2022
Thermo Fisher Scientific has recently certified the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System to comply with the new In Vitro Medical Devices Regulation (IVDR) requirements. To support this, the system has been updated and now incorporates the Applied Biosystems Diomni Software ecosystem. This integration aims to empower clinical labs and test developers by providing them with flexible PCR testing capabilities on-site.
The QuantStudio 7 Pro Dx Real-Time PCR System is designed to maximize productivity and facilitate a smooth transition from development to validation. It features an expandable and automated platform with interchangeable 96-well and 384-well blocks. Additionally, the system offers convenient features such as remote desktop and touchscreen controls, facial authentication, voice command functionality, and smart tech support to enhance user productivity.
Fernando Beils, the vice president and general manager of qPCR instruments at Thermo Fisher Scientific, emphasized the company's commitment to supporting customers during the transition to IVDR. They previously introduced the updated Applied Biosystems QuantStudio 5 Dx Real-Time PCR System, and now they are launching the IVDR-compliant QuantStudio 7 Pro Dx Real-Time PCR System along with the new complementary Diomni Software ecosystem. Thermo Fisher Scientific aims to provide innovative solutions that meet the evolving needs of test developers and laboratories as they expand their assay menus and IVD testing capabilities.
The Applied Biosystems Diomni Software ecosystem is an integrated software solution designed to streamline the entire workflow, whether it involves routine testing or the development of new assays. With its plug-and-play design and simplified setup, the software enhances efficiency and reduces user error. The centralized setup allows for connection to multiple real-time PCR instruments and facilitates secure data sharing across a user network.
Dr. Gustav Quade, a laboratory medicine and technical development specialist at the Quade Laboratory in Germany, praised the ease of integrating the QuantStudio 7 Pro Dx Real-Time PCR System with their laboratory information management software. He highlighted the ability of the new Diomni Software to support collaborative work, set up runs, manage past runs and documentation, and interpret fluorescent curves remotely and efficiently without requiring the installation of special software.
The QuantStudio 7 Pro Dx Real-Time PCR System is available in all regions that recognize CE-IVD certification and is classified as a class II medical device by the U.S. Food and Drug Administration (FDA)