Thermo Fisher Scientific Certifies Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System to Meet IVDR Requirements
12.9.2022 09:30:00 EEST | Business Wire | Press release
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220911005026/en/
Contact information
Media Contact Information:
Mauricio Minotta
Phone: 760-805-5266
Email: mauricio.minotta@thermofisher.com
Jennifer Heady
Phone: 413-237-5141
Email: jheady@greenough.biz
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
DDN Selected to Modernize Research Data Infrastructure at UNSW Sydney26.10.2026 23:30:00 EET | Press release
DDN, the global leader in AI and data intelligence solutions, today announced that UNSW Sydney has selected DDN to deliver a new research data storage environment as part of the university’s Research Data Experience (RDE) program. Working with Australian software company Arcitecta, DDN will combine its EXAScaler parallel file system with Arcitecta’s Mediaflux® data management platform to help researchers spend less time managing data and more time using it. Following an extensive 18-month evaluation, UNSW selected an integrated approach that will replace 11 legacy storage systems with a coordinated environment for high-performance storage and enterprise data management. The decision reflects a broader challenge facing research-intensive institutions: how to support rapidly expanding scientific datasets while simplifying infrastructure, improving data accessibility and managing long-term costs. Built for data-intensive research, high-performance computing and AI workloads, DDN EXAScaler
Agent Assurance by TestMu AI Is Now Generally Available, Letting Teams Test What Their AI Agents Actually Change26.10.2026 17:15:00 EET | Press release
TestMu AI (formerly LambdaTest), the world's first Agentic AI-powered Quality Engineering platform, today announced the general availability of Agent Assurance. Agent Assurance tests AI agents that take actions, such as calling tools, writing files, and changing records, by checking what a run actually changed rather than what the agent says it did. Any team can now create a TestMu AI account and run it against its own agent without booking a demo first. Agent Assurance launched on August 17, 2026, behind a waitlist and a guided onboarding session. Since then, Rook, the CLI that runs Agent Assurance, has shipped a steady run of releases, shaped by feedback from early teams. Agent evaluation has mostly graded the final reply, and that reply can be wrong about the agent's own work. In CXBench, a benchmark of LLM agents in regulated customer-experience workflows published in October 2026, 80.1% of runs that reached the right outcome still failed the process checks, and only 13.8% passed b
Actiphy Announces ImageServer for Centralized Backup Storage and Post-Backup Processing26.10.2026 17:13:00 EET | Press release
Actiphy™, Inc., a provider of backup, disaster recovery, and virtualization software, today announced Actiphy ImageServer™, a centralized platform for storing, managing, verifying, and replicating backups created with ActiveImage Protector™. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026410729/en/ Actiphy ImageServer Console ImageServer combines the management capabilities of Actiphy ImageCenter™ with the secure storage of Actiphy StorageServer™. By moving Verify, Replication, Consolidation, and BootCheck™ to a dedicated server, ImageServer reduces processing load on protected systems and simplifies backup administration. As organizations protect more systems and retain more backup generations, storage and administrative demands grow. ImageServer addresses these challenges by centralizing backup storage and management and automating post-backup processing. Key capabilities include: Inter-File Deduplication™ — Identifi
Dubai Chambers Launches World's First Agentic AI Marketplace by a Chamber of Commerce26.10.2026 17:06:00 EET | Press release
Dubai Chambers has launched Chamber AI Hub, the world's first Agentic AI marketplace developed by a chamber of commerce, enabling businesses in Dubai to access ready-to-use AI agents that independently perform a range of administrative and operational tasks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026467531/en/ H.E. Sultan bin Saeed Al Mansoori Chairman of Dubai Chambers. (Photo: AETOSWire) The marketplace currently offers 22 specialised AI agents across seven business functions including Compliance, Procurement, Operations, Finance, Sales, Human Resources, and Logistics. The offering is set to expand to 100 agents. The initiative supports Dubai's efforts to accelerate the adoption of Agentic AI across the private sector, helping businesses enhance efficiency, strengthen competitiveness, and transform their operating models. H.E. Eng. Sultan bin Saeed Al Mansoori, Chairman of Dubai Chambers, commented: “Success in
Media Release: Allianz Beach Arena for the LA28 Olympic and Paralympic Games Joins the Allianz Family of Stadiums26.10.2026 16:37:00 EET | Press release
For the first time in Olympic and Paralympic history, a competition venue will carry the Allianz name. The Allianz Beach Arena in Long Beach, California, for the LA28 Olympic and Paralympic Games will become the newest member of the Allianz Family of Stadiums. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026919959/en/ Allianz's "custom A" emblem for LA28. From Horse Guards Parade in London to Copacabana Beach in Rio and the Eiffel Tower in Paris, Olympic Beach Volleyball has always found its home in iconic settings around the world. At the LA28 Games, that home will carry the Allianz name. Allianz is proud to help celebrate this exciting sport in Long Beach, a city in the southern part of Los Angeles County where beach volleyball is part of everyday life and local culture. Set right on the Long Beach waterfront, the nearly 15,000 seat temporary arena will host the Olympic Beach Volleyball and the Paralympic Blind Footba
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom