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
Infobip Research Reveals Businesses Scaling AI-Powered Defenses to Counter Surge in Automated Fraud7.7.2026 12:55:00 EEST | Press release
New research from global AI-first cloud communications platform Infobip reveals a growing surge in AI-powered fraud and enterprise defenses. Analyzing billions of interactions globally, Infobip’s 2026 Fraud & Security Report highlights a year of dramatic contrasts. There have been record volumes of blocked fraudulent traffic alongside the rapid scaling of intelligent, AI-powered defenses. The report reveals that while fraudsters are using AI to scale and personalize harmful messaging, leading to a 77% increase in detected threats, businesses are responding in kind. Adoption of AI-powered fraud detection grew by 71% year-on-year, while pattern-based detection increased by 105%, underscoring a shift toward adaptive security. The report demonstrates the impact of AI-first security. Leading UK-based clothing brand NEXT is leveraging Infobip Signals, an AI and machine learning-powered solution designed to combat artificially inflated traffic, helping protect customers against fraud. Raz Raz
Santander Financial Crime Transformation Leader Joins ThetaRay to Drive Enterprise AI Adoption7.7.2026 11:00:00 EEST | Press release
ThetaRay, a leader in AI infrastructure for financial crime compliance, today announced the appointment of Luis Pinedo as Chief Strategic Customers Officer. Previously Pinedo was Group VP of Compliance at Santander Bank, where during his 16-year tenure, he led global Financial Crime Compliance (FCC) transformation initiatives across operating models, processes, and technology platforms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707359150/en/ Luis Pinedo joins ThetaRay as Chief Strategic Customers Officer. In his new role, Pinedo will bring key perspectives from tier-one banking operational challenges to ThetaRay’s product development and design. He will lead strategic customer engagement as well as product strategy across ThetaRay’s entire compliance platform, including Transaction Monitoring, Screening, Customer Risk Assessment, and Agentic Investigations. The appointment comes at a critical time in the RegTech indu
Robbyant Unveils LingBot-Depth 2.0 and LingBot-Vision to Redefine Robotic Spatial Perception7.7.2026 10:54:00 EEST | Press release
Robbyant, an embodied AI company within Ant Group, today announced the launch of LingBot-Depth 2.0, a next-generation spatial perception model, alongside its foundational visual model, LingBot-Vision. This release marks a significant leap in robotic spatial perception, empowering robots to accurately understand and navigate the physical world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706806935/en/ LingBot-Depth 2.0 reconstructs complete and planar 3D structures in challenging scenarios involving mirrors and glass From "Seeing" to "Seeing Accurately" Building upon the success of LingBot-Depth, which pioneered the Masked Depth Modeling (MDM) technique to resolve depth sensing challenges for transparent and reflective surfaces, LingBot-Depth 2.0 represents a massive scale-up in training data and performance. Trained on 150 million samples, the new model achieves top rankings in 12 out of 16 depth completion benchmarks.
RGI Group Strengthens Its Personal Insurance Capabilities in France Through KAPIA-RGI’s Acquisition of Cegid Assurex Solutions7.7.2026 10:30:00 EEST | Press release
RGI, a leading European provider of digital insurance platforms, announces that KAPIA-RGI, its France-based company specialised in personal insurance solutions, has acquired Cegid Assurex solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707323665/en/ This transaction marks a major milestone in the Group's development strategy in French speaking markets in Europe and further enhances its ability to support insurers, mutual insurers, provident institutions, brokers and bancassurers in their innovation and digital transformation initiatives. By integrating Cegid Assurex's expertise, talent and solutions, KAPIA-RGI consolidates its position as the reference leader in the Life Insurance, Savings, Retirement, Annuities and Provident markets. This acquisition expands its client base with more than 20 additional customers while accelerating innovation and growth in a market shaped by evolving regulation, automation and a
Bitcoin Suisse Advances Middle East Expansion, Receiving Financial Services Permission in Abu Dhabi7.7.2026 10:15:00 EEST | Press release
Building on its position as Switzerland’s leading crypto financial services provider, Bitcoin Suisse is further accelerating its international expansion. Bitcoin Suisse Group’s subsidiary, BTCS (Middle East) Ltd. (“BTCS ME”) has received Financial Services Permission (FSP) from the Financial Services Regulatory Authority (FSRA) of ADGM, the international financial centre of Abu Dhabi, marking another significant step toward the Group’s international growth strategy becoming a leading global wealth management partner. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707864200/en/ Ceyda Majcen, Chief Executive Officer and SEO of BTCS ME, leads Bitcoin Suisse Group's expansion in the Middle East and brings extensive, long-standing senior leadership experience across the Group. The FSP marks the completion of a thorough, multi-stage licensing process and enables BTCS ME to deliver a comprehensive suite of regulated digital asse
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