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
Draslovka to Acquire ex-Natron Energy Battery IP, Completing a Vertically Integrated Western Sodium-Ion Value Chain29.10.2026 15:30:00 EET | Press release
Draslovka’s US-based subsidiary, COVORO MINING SOLUTIONS LLC (Covoro), the operator of one of the largest solid sodium cyanide plants in the world, today announced that it has agreed to acquire the intellectual property portfolio in Prussian Blue Analogue (PBA) and Prussian White Analogue (PWA) sodium-ion battery technology originally developed by Natron Energy. Prussian Blue and Prussian White Analogues are not a single material but a tunable family of framework materials, and the portfolio protects that family across the whole stack — active-material synthesis, electrodes, electrolytes, cell design and manufacturing, as well as complete battery systems — through issued and pending patents, trademarks, and manufacturing know-how, with protection extending into the mid-2040s. The agreement covers intellectual property and intangible assets only and was subject to review by the Committee on Foreign Investment in the United States (CFIUS), which granted clearance as a condition to closin
Veracode Finds First Meaningful Gain in AI Code Security Since 2025 as Average Pass Rate Hits 62%29.10.2026 15:27:00 EET | Press release
Veracode, the global leader in application risk management, today announced a jump from 56 percent to 62 percent in overall AI-generated code security, alongside a drop in vulnerabilities from 44 percent to 38 percent — the most significant improvement since the GenAI Code Security Report series began in July 2025. Anthropic's Claude Opus 5.5 and OpenAI's GPT-6-Sol co-lead the rankings at 73 percent, surpassing the previous high of 68 percent set by GPT-5.5 in July 2026. “We’ve been analysing code generated by multiple LLMs for more than a year. Until now, we have not seen a marked improvement in AI code security, despite consistently near-perfect functionality,” said Chris Wysopal, Co-founder & Chief Security Evangelist at Veracode. “This is the first time since running our study that we’ve been able to report a meaningful move on the security dial. Ten models now clear 60 percent, up from four in the last report, and the overall average has jumped six percentage points. With around h
LeBron James Deepens Commitment to WHOOP, Expanding 11-Year Relationship29.10.2026 15:00:00 EET | Press release
WHOOP, the human performance brand, today announced that basketball legend LeBron James has joined as a global ambassador, formalizing a relationship that began more than a decade ago. One of the company's earliest members and now an investor, James will partner with WHOOP to champion the importance of sustained athletic excellence and everyday vitality. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029868502/en/ LeBron James Deepens Commitment to WHOOP, Expanding 11-Year Relationship James began wearing WHOOP in 2015, long before continuous health monitoring became mainstream. Today, on the 23rd anniversary of his NBA debut, the 41-year-old continues to compete at the highest level of professional basketball. His decision to formalize the partnership reflects an 11-year relationship rooted in a shared commitment to performance, recovery, and longevity. The expanded partnership brings together one of the world's most acc
Xsolla Acquires GamePix to Build a Complete Platform for Web and AI-Created Video Games29.10.2026 15:00:00 EET | Press release
Xsolla, a global commerce company, today announced it acquired GamePix, the web games platform that publishes and distributes browser games worldwide. GamePix brings a catalog of 10,000+ web titles, a community of 4,000+ developers, and a publishing solution that brings any game to your web browser, from PC and mobile titles ported with its own technology to video games built with AI. Xsolla adds this commerce infrastructure to monetize those video games across 200+ geographies. Together, they give developers a single path from a finished video game to a paying, global audience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021024495/en/ Graphic: Xsolla Edouard Wawra, Valerio Pullano and Justine Silipo founded GamePix in 2013, when web games still ran on Flash. Since then, GamePix has moved with every shift in browser technology, from HTML5 and WebGL to WebGPU and now AI-created video games, building partnerships with in
IFCO Demonstrates Sustainability Leadership by Combining Record Environmental Performance With Business Growth29.10.2026 14:38:00 EET | Press release
IFCO, a global leader in reusable packaging solutions for fresh food, today published its ESG Report 2026. The report covers July 1, 2025, to June 30, 2026 and marks the first year of reporting against IFCO's Thriving with Purpose 2030 ESG strategy. During fiscal year 2026, the company managed an impressive 2.6 billion reusable packaging container (RPC) trips while reducing material greenhouse gas emissions by 11%. At the same time, customers using IFCO RPCs avoided 832,970 metric tons of CO₂e emissions, an increase of 13% compared with the previous year. Michael Pooley, CEO of IFCO: "The first year of our Thriving with Purpose 2030 ESG strategy showed that growth and sustainability go hand in hand. By expanding our network, investing in IFCO Digital, and scaling our circular model for reusable transport packaging, we are building a stronger, smarter business while helping our customers build more transparent and resilient fresh food supply chains." Growing the circular economy while r
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