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
First and Only Ulcerative Colitis Treat-to-Target Trial Shows Treating to Disease Clearance vs. Symptomatic Remission with ENTYVIO ® (vedolizumab) Prolongs Time to First Disease-Related Complication19.10.2026 12:30:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) announced new data from VERDICT (NCT04259138), showing that treating adults with intravenous ENTYVIO® (vedolizumab) to achieve corticosteroid-free (CSF) disease clearance versus CSF symptomatic remission alone, resulted in a significantly longer time to first ulcerative colitis (UC)-related complication (hazard ratio 0.33 [95% confidence interval 0.17-0.67]; P=0.0014), reducing UC complication risk by nearly 70 percent. VERDICT, a Phase 4 ENTYVIO clinical trial, provides the first prospective, randomized evidence that disease clearance is an achievable and clinically relevant target in the treatment of moderate to severe ulcerative colitis.1 Results were presented during late-breaker and poster sessions at United European Gastroenterology (UEG) Week 2026 and published in the United European Gastroenterology Journal. “There has been increasing conversation about whether achieving deeper levels of remission – addressing both visible and microscopic inflammation
Boomi Acquires Elementary Data to Bring Trusted, Governed Data to the AI Era19.10.2026 12:00:00 EEST | Press release
Boomi, the data activation company for AI, today announced it has acquired Elementary Data, a provider of the widely adopted data observability solution that powers every workflow and AI agent with reliable data. Following Lunar.dev, Elementary is Boomi’s latest acquisition, strengthening the Boomi Enterprise Platform with the observability, quality, governance, and discovery capabilities enterprises need to deliver trusted data for AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019376249/en/ Boomi Acquires Elementary Data to Bring Trusted, Governed Data to the AI Era Key Takeaways What Boomi acquired. Elementary provides unified observability, quality, governance, and discovery. Founded in 2022, Elementary began as an open-source project — now adopted by 1,500+ data teams, with 1.1M + monthly downloads, and a ~4,000-member community. In 2024, it launched Elementary Cloud which added enterprise-grade capabilities on t
Reply Earns “NVIDIA Physical AI Specialization” for Production-Ready Robotics and Digital Twins19.10.2026 11:00:00 EEST | Press release
Reply [EXM, STAR: REY] is among the first NVIDIA partners in the world to achieve the “Physical AI Specialization” within the NVIDIA Partner Network (NPN), in recognition of its expertise in developing and deploying AI-driven robotics and digital twin solutions for real-world operating environments. The specialization was awarded following a technical assessment covering a customer implementation, solution architecture, certified OpenUSD expertise and Reply’s development roadmap. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019881053/en/ Reply is among the first NVIDIA partners in the world to achieve the “Physical AI Specialization” within the NVIDIA Partner Network (NPN), in recognition of its expertise in developing and deploying AI-driven robotics and digital twin solutions for real-world operating environments. Physical AI is becoming increasingly relevant in manufacturing, warehousing and logistics as companies mo
Sagemcom Unveils Its New-Generation of VSB (Video Soundbox), Now Bringing Home Cinema and Karaoke to Every Living Room, First Deployed by DNA in Finland19.10.2026 11:00:00 EEST | Press release
Sagemcom announces the immediate availability of the new generation of VSB (Video Soundbox). Since its launch, operators around the world have chosen Video Soundbox to offer their customers a 4K set-top box and speakers combined in a single device. Building on this success, Sagemcom introduces its new VSB that takes home entertainment one step further. It is the world’s first set-top box for operators based on Broadcom’s BCM74116 SoC to be deployed. The VSB now offers deeper bass and wider sound spatialization for an even more immersive experience. Thanks to audio designed by Bang & Olufsen and Dolby Atmos, the sound is pure, powerful and multidimensional for all types of content. Dolby Vision brings true colors and sharp pictures. Today, the VSB goes far beyond the traditional TV experience. It can be further enhanced with Wireless Surround Speakers. Available as an option, they extend the sound across the entire room: films and series take on a true cinema dimension, while live sport
EchoMark Launches European Operations and Partner Ecosystem19.10.2026 11:00:00 EEST | Press release
EchoMark, the award winning invisible forensic watermarking company that identifies the source of information leaks, often in minutes, today announced the launch of its European operations. The full EchoMark platform is now available with European Union data residency, giving customers the option to run watermarking, administration, and leak investigations entirely on EU-based infrastructure. EchoMark has also entered into a partnership with Nomios, a leading European cybersecurity services provider, to deliver, deploy, and support the platform across the region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909554797/en/ EchoMark is also investing in the wider European insider risk community. The company has joined the Insider Risk Practitioner Alliance (IRPA) as a Secretariat Tier 2 Partner and is a Gold sponsor of the UK Insider Risk Management Collaboration Centre and the Nordic Insider Risk Management Centre of Exce
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