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
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 19:36:00 EEST | Press release
NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s enterprise AI strategy as demand accelerates for AI-driven, cloud-native transformation. By expanding capabilities across data platforms, agentic AI and modern applications, NTT DATA is sharpening its ability to deliver production-ready AI solutions aligned to industry needs, reinforcing its leadership as Microsoft’s Global System Integrator (GSI) Growth Champion Partner of the Year. Upon closing, WinWire will add more than 1,000 skilled Azure engineers and Microsoft specialists to NTT DATA,
STARTEEPO Invest Announces 5% Stake in Xerox Holdings Corporation15.5.2026 19:15:00 EEST | Press release
STARTEEPO Invest (“STARTEEPO”), an alternative investment fund focused on public equity opportunities, today announced that it has acquired a significant ownership position in Xerox Holdings Corporation (“Xerox” or the “Company”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515594020/en/ As of the date of this release, STARTEEPO and its affiliates beneficially owns 6.6 million shares of Xerox (excluding options), representing approximately 5.05% of the Company’s outstanding common stock. STARTEEPO has filed a Schedule 13D with the U.S. Securities and Exchange Commission (the “SEC”) providing additional details regarding its investment. Investment Perspective STARTEEPO believes that Xerox represents an interesting investment opportunity supported by a combination of balance sheet initiatives, ongoing operational improvements, and its position within a changing and consolidating industry. In STARTEEPO’s view, the Company
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 17:00:00 EEST | Press release
NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s enterprise AI strategy as demand accelerates for AI-driven, cloud-native transformation. By expanding capabilities across data platforms, agentic AI and modern applications, NTT DATA is sharpening its ability to deliver production-ready AI solutions aligned to industry needs, reinforcing its leadership as Microsoft’s Global System Integrator (GSI) Growth Champion Partner of the Year. Upon closing, WinWire will add more than 1,000 skilled Azure engineers and Microsoft specialists to NTT DATA,
Experian Expands Agent Trust Partner Ecosystem with Akamai to Advance Trusted AI Driven Commerce15.5.2026 16:00:00 EEST | Press release
Experian today announced that Akamai Technologies has joined its growing partner ecosystem, designed to further advance secure, trusted AI driven commerce through the Experian Agent Trust™ framework, alongside partner Skyfire supporting emerging payment innovation. As AI agents begin to search, decide, and transact autonomously, they introduce a fundamental challenge for businesses: how to trust an action when it is no longer directly initiated by a human. Without a verified connection between humans and AI agents, autonomous commerce introduces new risks in fraud, misrepresentation, and unauthorized transactions. Experian Agent Trust is designed to address this challenge by establishing identity, accountability, and trust in agent driven interactions. “Trust, security, and performance must scale alongside the growing role of AI agents in digital commerce,” said Kathleen Peters, Chief Innovation Officer at Experian. “Agentic commerce will not scale without trust. By adding Akamai to ou
The LYCRA Company and Dukane Advance Ultrasonic Bonding for Nonwovens at INDEX™ 2615.5.2026 15:00:00 EEST | Press release
The LYCRA Company, a global leader in innovative and sustainable fiber solutions for the personal care industry, and Dukane, a manufacturer of ultrasonic bonding technologies for the hygiene and nonwovens market, are showcasing their latest co-developed advances in ultrasonic bonding at INDEX™ 26, taking place in Geneva, Switzerland, from May 19–22. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515514441/en/ Join The LYCRA Company and Dukane at INDEX™ 26 in Geneva, as they showcase their latest advances in ultrasonic bonding for nonwovens, including new LYCRA FUSION™ fiber for personal care that delivers superior snapback. Since 2014, both companies have collaborated to advance ultrasonic bonding solutions that help diaper manufacturers improve product softness, fit, and performance while reducing energy consumption, material waste, and maintenance costs. Ultrasonic bonding creates bonded channels between two layers of n
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