QuantStudio 7 Pro Dx certified to meet new IVDR requirements

CARLSBAD, Calif. — Thermo Fisher Scientific has certified the Applied Biosystems QuantStudio 7 Pro Dx* Real-Time PCR System to meet new In vitro Requirements of the Medical Device Regulation (IVDR). The updated system now includes a new, complementary ecosystem of Applied Biosystems Diomni software to enable clinical laboratories and test developers to take advantage of flexible on-site PCR testing.

Designed for maximum productivity and rapid scale-up, the QuantStudio 7 Pro Dx Real-Time PCR System allows users to move from development to validation on a single system. The expandable, automated platform comes with interchangeable 96- and 384-well blocks and also includes remote desktop and touchscreen controls, face authentication, voice control, and smart tech support to increase worker productivity. users.

“We have continued to support our customers through the transition to IVDR, first by introducing the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System earlier this year and now with the launch of Real-Time PCR real QuantStudio 7 Pro Dx IVDR compliant. Diomni Software complementary system and new ecosystem,” said Fernando Beils, vice president and general manager of qPCR instruments at Thermo Fisher Scientific. “As test developers and labs expand their test menus and IVD testing capabilities, we are committed to continuing to provide innovative solutions to meet their evolving needs.”

Whether performing a routine assay or developing a new assay, the integrated ecosystem of Applied Biosystems Diomni IVDR-compliant software is designed to streamline the entire workflow with a plug-in design. and-play and simplified setup to improve efficiency and minimize user error. Centralized setup allows connection to multiple real-time PCR instruments and secure data sharing across a user network.

“The ability to import plate setup files from external software and export result sets in a customizable structure made it easy to integrate the QuantStudio 7 Pro Dx Real-Time PCR System into our software. laboratory information management,” said Dr. Gustav Quade, laboratory medicine and technical development specialist at Quade Laboratory in Germany. “The new Diomni software makes it easier to work collaboratively and we can set up runs, manage past runs and documentation, and interpret fluorescence curves remotely and efficiently without the need to install special software.”

The QuantStudio 7 Pro Dx Real-Time PCR System is available in all regions that recognize CE-IVD certification and is also listed with the United States Food and Drug Administration (FDA) as a Class II medical device .

*The QuantStudio 7 Pro Dx Real-Time PCR System is intended for in vitro diagnostic use