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
Beacon Acquires Haize Labs to Power AI for the Real Economy17.9.2026 17:30:00 EEST | Press release
Beacon Software (Beacon), the first centralized AI holding company, today announced that it has acquired Haize Labs, an AI reliability company that tests and safeguards AI agents for real-world deployment. The Haize Labs team will join Beacon to form its Applied AI Research Group, with co-founder and CEO Leonard Tang joining as VP of AI Research to lead the AI operating system that is deployed across Beacon’s companies. Beacon believes that the fastest way to bring AI to the traditional economy is through the software businesses that essential industries already use and trust, equipping them with AI infrastructure. Beacon acquires these businesses for long-term growth and connects them to a centralized AI operating system that compounds with each additional acquisition and industry. The addition of the Haize Labs team will strengthen this centralized technology platform, which provides shared engineering, AI, product and go-to-market capabilities to Beacon’s portfolio of 45 software co
TIMELAB Develops OEM/ODM Hair Straightener Reaching 200°C at All Three Measured Points in 15 Seconds17.9.2026 17:00:00 EEST | Press release
TIMELAB Co., Ltd., a Japanese beauty-appliance OEM/ODM provider, has developed a hair straightener for OEM/ODM customization for international hair care brands and professional markets. In testing at 230 V with a 260°C setting, all three measured plate locations reached at least 200°C after 15 seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914187865/en/ Three-Point Plate Testing A European-market development unit with a maximum setting of 260°C was tested at 230 V. Fifteen seconds after power-on, readings at the front, center and rear were 212.5°C, 227.5°C and 200.0°C, respectively. From around 60 seconds onward, temperature differences among the three points narrowed, indicating a stable trend. Precision Temperature Control An NTC sensor inside the metal ceramic heater (MCH) detects temperature. A microcontroller (MCU) reads the signal and adjusts heater output. Upper and lower MCH heaters are controlled indepen
Earnix Brings Agentic AI to the Decisions That Drive Insurance Performance17.9.2026 16:09:00 EEST | Press release
Earnix today announced the introduction of Agent Hub, a curated catalog of insurance-specific AI agents and apps within Earnix AIOS — the AI Orchestration System powering Earnix’s pricing and rating, underwriting, and customer engagement solutions. Agent Hub brings agentic AI directly into these solutions, enabling more intelligent workflows and strengthening the high-stakes decisions that shape pricing, underwriting, customer engagement, growth, and profitability. In an increasingly turbulent insurance environment, the useful life of an insurance decision is getting shorter. Risk and market conditions are changing faster, making growth, profitability, and portfolio performance harder to manage. AI is increasing the speed and scope of what insurers can analyze, recommend, and increasingly act on — but as intelligence moves closer to action, the standard for governance, explainability, and accountability also rises. For insurers, that shift has direct implications for both financial per
Medisca Launches Global Peptide Division17.9.2026 16:07:00 EEST | Press release
Medisca today announced the launch of Medisca Peptides, a dedicated global division focused on expanding access to API-grade peptides and building an integrated peptide platform for pharmaceutical and personalized medicine markets worldwide. As the peptide landscape evolves, Medisca is proactively building the capabilities and infrastructure needed to support API-grade peptides within applicable regulatory frameworks. The launch represents a significant long-term commitment to peptides, including the expansion of Medisca’s portfolio, strategic manufacturing relationships, and the pharmaceutical infrastructure needed to support the category’s growth. It also signals Medisca’s ambition to become a leading force in the next generation of peptide innovation. For Medisca, the opportunity is familiar. More than 35 years ago, the company was founded to help close the gap between the pharmaceutical standards compounders needed and the quality ingredients they could readily access. Today, as pe
Elliptic Launches Its Decode Agent to Answer On-Chain Risk Questions and Shows Its Work17.9.2026 16:00:00 EEST | Press release
Elliptic, the global leader in on-chain risk, today launched Decode, an AI agent built on Elliptic’s intelligence platform. The Decode agent answers natural-language questions about cryptoasset addresses and their exposure in seconds, and returns the evidence behind every answer. Compliance and investigations teams need answers to questions nobody planned for. Getting them out of the data is now a specialist skill, so the questions wait for someone who has it, or go unasked. Meanwhile illicit actors move at machine speed, and agents are starting to sit on both sides of a payment. General-purpose AI assistants can produce an answer. They cannot show where it came from. A fluent response with nothing behind it cannot be put in front of a second-line reviewer, an auditor, or a regulator. “The market is full of AI that asks to be trusted. That is not good enough when someone asks how you reached a decision,” said Jackson Hull, CTO at Elliptic. “We published the Elliptic Standard last week
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