08:54 uur 12-09-2022

Thermo Fisher Scientific certificeert Applied Biosystems QuantStudio 7 Pro Dx real-time PCR-systeem om te voldoen aan IVDR-vereisten

Bijgewerkt qPCR-systeem bevat nu geïntegreerde software ter ondersteuning van groeiende testmenu’s voor klinische laboratoria en testontwikkelaars

CARLSBAD, Californië–(BUSINESS WIRE)– Thermo Fisher Scientific heeft het Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR-systeem gecertificeerd om te voldoen aan de nieuwe vereisten van de In Vitro Medical Devices Regulation (IVDR). Het bijgewerkte systeem bevat nu een nieuw, aanvullend Applied Biosystems Diomni Software-ecosysteem om klinische laboratoria en testontwikkelaars in staat te stellen gebruik te maken van flexibele PCR-tests ter plaatse.

Het QuantStudio 7 Pro Dx Real-Time PCR-systeem is ontworpen voor maximale productiviteit en snelle opstart en stelt gebruikers in staat om op één systeem over te stappen van ontwikkeling naar validatie. Het uitbreidbare, geautomatiseerde platform wordt geleverd met verwisselbare blokken met 96 putjes en 384 putjes en omvat ook externe desktop- en touchscreenbediening, gezichtsverificatie, spraakopdrachten en slimme technische ondersteuning om de gebruikersproductiviteit te verhogen.

Thermo Fisher Scientific Certifies Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System to Meet IVDR Requirements

Updated qPCR system now includes integrated software to support growing test menus for clinical laboratories and assay developers

CARLSBAD, Calif.–(BUSINESS WIRE)– Thermo Fisher Scientific has certified the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System* to meet new In Vitro Medical Devices Regulation (IVDR) requirements. The updated system now includes new, complementary Applied Biosystems Diomni Software ecosystem to empower clinical labs and test developers to leverage flexible PCR testing onsite.

Designed for maximum productivity and fast ramp-up, the QuantStudio 7 Pro Dx Real-Time PCR System enables users to transition from development to validation on a single system. The expandable, automated platform comes with interchangeable 96-well and 384-well blocks and also includes remote desktop and touchscreen controls, facial authentication, voice command and smart tech support to increase user productivity.

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

Whether performing a routine test or developing a new assay, the integrated, IVDR-compliant Applied Biosystems Diomni Software ecosystem is designed to streamline the entire workflow with a plug-and-play design and simplified set-up to enhance efficiency and minimize user error. The centralized set-up allows connection to multiple real-time PCR instruments and secure data sharing across a user network.

“The ability to import plate set-up 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 with our laboratory information management software,” said Dr. Gustav Quade, laboratory medicine and technical development specialist at the Quade Laboratory in Germany. “The new Diomni Software makes it easy to work collaboratively and we can set up runs, manage past runs and documentation, and interpret fluorescent 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 U.S. Food and Drug Administration (FDA) as a class II medical device.

For more information, please visit www.thermofisher.com/quantstudio7prodx.

*The QuantStudio 7 Pro Dx Real-Time PCR System is For In Vitro Diagnostic Use.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

For more information, please visit www.thermofisher.com


Media Contact Information:

Mauricio Minotta

Phone: 760-805-5266

Email: mauricio.minotta@thermofisher.com

Jennifer Heady

Phone: 413-237-5141

Email: jheady@greenough.biz

Check out our twitter: @NewsNovumpr