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
New INRIX Parking Scorecard Reveals Cities with the Most Parking, Highest Prices, and Lowest Availability7.10.2026 23:16:00 EEST | Press release
INRIX, a leader in transportation analytics and mobility intelligence, today released its first-ever INRIX Parking Scorecard, the largest comparative analyses of downtown parking conditions across North America and Europe. Drawing on parking availability, curb regulations, pricing data and parking infrastructure from more than 120 downtown areas in 14 countries, the report reveals significant differences in parking conditions and how cities allocate curb space. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007322796/en/ New INRIX Parking Scorecard: Where Downtown Parking Costs Most The Scorecard examines parking availability: the probability of finding a parking space alongside on-street and off-street parking pricing, and curb use policies. The findings show that parking conditions vary dramatically between cities, both overall and by time of day and day of the week, with implications for everything from the driver expe
Lattice Collaborates with Arm to Advance Secure, Adaptable AI Data Center Infrastructure7.10.2026 23:00:00 EEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced a collaboration with Arm to enable secure control, management, and platform adaptability for AI infrastructure. Combining Arm® AGI CPU server platforms with Lattice FPGAs and AMI firmware creates a solution that provides advanced security, manageability, connectivity, and flexibility for next-generation AI data center infrastructure. In Arm AGI CPU server platforms, Lattice FPGAs work alongside the CPU and baseboard management controller, with AMI firmware providing platform boot and management capabilities. The Lattice FPGAs act as companion chips providing secure control and management capabilities, enabling platform trust, connectivity, and infrastructure adaptability. Lattice FPGA technology also enables Open Compute Project (OCP)-compliant connectivity between the Host Processor Module (HPM) and Datacenter Secure Control Module (DC-SCM) through the LVDS Tunneling Protocol
Bentley Systems Announces Winners of the 2026 Year in Infrastructure Awards7.10.2026 20:55:00 EEST | Press release
(The Bentley Systems 2026 Year in Infrastructure Event) – Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced the winners of the 2026 Year in Infrastructure Awards. For more than 20 years, the awards have honored the extraordinary work of infrastructure professionals and their innovative use of Bentley software to improve how infrastructure is designed, built, and operated. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007964087/en/ Bentley Systems announced the winners of the 2026 Year in Infrastructure Awards on October 7, 2026 (Photo courtesy of Bentley Systems) In 2026, over 300 projects were nominated by organizations in 53 countries. Winners were selected across 12 categories spanning the infrastructure lifecycle, industries, and disciplines by a panel of independent judges during the Bentley Systems 2026 Year in Infrastructure Event, held October 6-7 in Sin
Day One Strategy Founders Recognised in The LDC Top 50 Most Ambitious Business Leaders for 20267.10.2026 20:00:00 EEST | Press release
Hannah Mann and Abigail Stuart, Co-Founders of Day One Strategy have been recognised as one of The LDC Top 50 Most Ambitious Business Leaders for 2026. The programme was created by private equity investor LDC, part of Lloyds Banking Group, in partnership with The Times. Since 2018, it has celebrated the ambition and achievements of hundreds of exceptional entrepreneurs. This year The LDC Top 50 attracted more than 620 nominations from across the UK, highlighting the depth of ambition among leaders building successful businesses in every region and sector. The leaders featured are driven by an appetite for growth that is helping to build stronger, more sustainable businesses and a more competitive UK economy. They are expanding internationally, developing new products and services, challenging established markets and investing in their people. Together, their businesses generate £1.4bn in annual revenues and employ almost 8,500 people. Headquartered in 55 towns and cities, they demonstr
TestMu AI Adds Evidence Packs to Kane CLI, Turning Every AI Test Run into One Portable, Shareable File7.10.2026 17:29:00 EEST | Press release
TestMu AI (formerly LambdaTest), the Full Stack Agentic AI Quality Engineering platform, announced evidence packs for Kane CLI, its terminal-first tool for natural language browser and mobile app testing. Every Kane CLI run now produces one sealed .evidence file that holds the complete record of what the AI agent was asked to do, what it did at each step, and what happened. Kane CLI launched in April 2026, giving developers and AI coding agents a way to run tests on real browsers and mobile apps from the terminal, in plain English, with a clear pass-or-fail verdict. Since launch, it has added AI-powered test case generation and the Assurance Lifecycle, which ties tests back to requirement documents. Evidence packs are the next step: a full record of every run. As AI agents write and run more tests, engineering teams need a clear answer to a simple question: what exactly did the agent do, and why did the run pass or fail? That proof is often spread across screenshots, log folders, and d
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