Thermo Fisher Scientific Updates Applied Biosystems QuantStudio 5 Dx Real-Time PCR System to Comply with IVDR Regulations
7.6.2022 15:00:00 EEST | Business Wire | Press release
To help molecular diagnostic manufacturers and clinical testing laboratories adapt to higher-standard In Vitro Diagnostic Requirements (IVDR) now in effect in the European Union, Thermo Fisher Scientific is offering an IVDR version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System globally. The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220607005144/en/
The IVDR-compliant QuantStudio 5 Dx System simplifies molecular diagnostic workflows for infectious disease and oncology. (Photo: Business Wire)
Molecular diagnostic kit manufacturers and clinical testing labs that develop their own assays need open qPCR platforms that meet IVDR requirements. The IVDR-compliant QuantStudio 5 Dx System will enable molecular diagnostic manufacturers to develop new IVDR-compliant tests under the new regulations. The system will also help clinical labs running diagnostic tests switch to IVDR qPCR testing.
“Molecular diagnostic manufacturers and laboratories that lack appropriately validated and CE-labelled instruments and tests may face delays under the new IVDR regulations,” said Marty Murawski, vice president, regulatory and quality assurance, at Thermo Fisher Scientific. “We are committed to helping our customers maintain high patient safety standards, meet new requirements, and obtain proper accreditation to remain competitive in today’s market. By making the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System IVDR-compliant, we can now provide a high-performance, reliable qPCR system to support new testing workflows.”
Among the system’s updates, the multi-mode software is now IVDR compliant, providing dual functionality for running diagnostic tests and developing new assays in today’s regulatory environment. The qPCR system comes with an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes. In addition, a security, auditing, e-signature module provides secure operation.
The updated QuantStudio 5 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).
For more information, please visit www.thermofisher.com/quantstudio5dx.
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/20220607005144/en/
Contact information
Media:
Mauricio Minotta
Phone: 760-805-5266
Email: mauricio.minotta@thermofisher.com
Jen 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
Multiple Industry Honors Reinforce CSG/Netcracker Leadership in Customer Journey Orchestration and AI Innovation24.9.2026 18:05:00 EEST | Press release
The next phase of customer experience hinges on how well brands turn customer data into relevant communications, real-time action, and responsible, proven AI use. CSG® and Netcracker Technology today announced that CSG has been named a Leader in The Forrester Wave™: Customer Journey Orchestration Platforms, Q3 2026, with the highest possible scores in 19 of 23 Forrester Wave™ criteria. CSG Xponent, a best-in-class customer engagement platform, helps brands land timelier, more relevant communications that drive customer action, secure loyalty, and bolster measurable business results. The Forrester Wave™: Customer Journey Orchestration Platforms states that, “CSG earns superior scores across the core journey intelligence and orchestration capabilities that define this market. Its excellent journey simulation, predictive intelligence, and decisioning capabilities help organizations evaluate likely outcomes before introducing changes into live journeys, improving decision confidence and re
Vasion Ⓡ Enhances Global Partner Program to Accelerate AI-Powered Automation24.9.2026 17:05:00 EEST | Press release
VasionⓇ, the Intelligent Print Automation platform trusted by more than 14,000 organizations worldwide, today unveiled a comprehensive refresh of its Global Partner Program. The program delivers the resources partners expect from Vasion: always-on incentives, structured onboarding, elevated enablement, and a rebuilt portal experience, all engineered to help partners scale, compete, and deliver stronger customer outcomes as agentic AI reshapes how enterprises automate work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924791639/en/ Agentic print and document workflow environments remain an overlooked channel opportunity, as enterprises race toward agentic automation. IDC forecasts that by 2026, 40% of all Global 2000 job roles will involve working with AI agents, redefining long-held traditional entry-level, mid-level, and senior-level positions [1]. IDC's research points to this new class of AI reshaping not just how fa
The Only AI Crypto Lead Prioritization Solution Built With Law Enforcement, for Law Enforcement: Elliptic Launches Pulse24.9.2026 16:15:00 EEST | Press release
Elliptic, the global leader in on-chain risk, today launched Pulse. Pulse puts crypto lead prioritization directly in the hands of every frontline law enforcement and government officer. Crypto now touches every part of law enforcement, from the patrol officer on the street to the detective assigned to investigate the case. Pulse gives each of them a quick, accurate financial summary and a starting point: whether that's a crypto address on a suspect's phone, in a scam ATM victim's receipt, uncovered during a vehicle or pocket search, or found at the scene of an overdose, an arrest, or a seizure. An officer can input anything that looks like a wallet address or transaction hash. Pulse identifies it, reasons over the result, and returns a summary in plain language, enough for the officer to decide on the spot whether the case needs escalation. If a case needs further investigation, one click sends the full analysis forward, not just the evidence. The criminal investigations division gets
SymphonyAI Introduces Symphony Risk Intelligence, an Agent-native Platform That Unlocks Always-on Compliance™ — the Catalyst for Transforming the Financial Crime Operating Model24.9.2026 16:04:00 EEST | Press release
SymphonyAI today introduced Symphony Risk Intelligence (SRI), an enterprise-grade, agent-native platform built to unlock Always-on Compliance™. This is a critical shift from periodic to continuous risk and compliance management, in which institutions continuously reassess risk and adapt controls as regulations, threats and business activity change, rather than waiting for the next scheduled review. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260924914614/en/ Current approaches have reached their structural limits. The FinCrime Frontier 2026–27 Report, released recently by SymphonyAI and AML Intelligence, finds just 4.7% of financial institutions continuously update their compliance monitoring and controls as risk changes, and 76.3% still review alerts manually or with only partial automation — barely changed year over year. Yet standing still isn't an option: the regulatory climate is at a major inflection point across ev
Just 4.7% of Financial Institutions Continuously Update Their Compliance Monitoring and Controls as Risk Changes, New Research Finds24.9.2026 16:04:00 EEST | Press release
SymphonyAI, a global leader in vertical AI product platforms, and AML Intelligence, the leading source of news and insight for the financial crime compliance community, today released the FinCrime Frontier 2026–27 Report, finding that most financial institutions still rely on periodic review cycles to manage financial crime risk, even as the threats and regulations they are meant to track continue to evolve dynamically. Based on the perspectives of more than 200 financial crime and compliance leaders, including senior leaders from major global financial institutions, the research finds that just 4.7% of financial institutions continuously update their compliance monitoring and controls as risk changes, while 56.8% have not adopted always-on compliance monitoring at all, are only exploring it, or remain at an early, pilot-stage level. The finding points to a structural gap: financial crime typologies, payment ecosystems and regulatory expectations are evolving continuously, while most c
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