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
Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher24.4.2026 17:37:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling review request and selected COMP360, Compass’ proprietary formulation of synthetic psilocybin, for the Commissioner's National Priority Voucher (CNPV) program for treatment-resistant depression (TRD). Companies selected for the voucher program will be entitled to benefits including enhanced communications and a shortened 1-2 month review time following filing of a New Drug Application (NDA), while maintaining FDA’s rigorous safety and efficacy standards. “We are honored and grateful to be selected for the CNPV which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “As the most advan
Banma Intelligence and Alipay Launch AI Cockpit Solution Powered by Alipay AI Pay, Enabling Seamless and Secure In-Car Transactions by Voice24.4.2026 17:04:00 EEST | Press release
At the 2026 Beijing International Automotive Exhibition (“Auto China 2026”), OS and AI technology company Banma Intelligence and Alipay today launched a new AI cockpit solution integrating Alipay AI Pay, enabling drivers to complete purchases by voice command directly from their vehicle. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424618328/en/ Industry-first AI Cockpit Solution with Alipay AI Pay Unveiled “In the past two years, smart cockpits have achieved rapid advances in perception and decision-making,” said Ming Cai, Banma Intelligence Chief Product Officer. “With large models onboard, vehicles can understand user intent and make recommendations. By integrating Alipay AI Pay into our AI cockpit solution, we are removing the last friction point in the in-car smart cockpit experience - drivers simply speak to pay, no phone required.” The new AI cockpit solution initially covers two high-frequency use cases: enterta
Spatial Announces the Release 2026 1.0.1: New Enhancements Across 3D InterOp, Data Prep, Meshing, and 3D Modeling SDKs24.4.2026 16:21:00 EEST | Press release
Spatial Corp., the leading software development kit provider for design, manufacturing and engineering solutions and a subsidiary of Dassault Systèmes, today announced new enhancements across several of its product lines. These updates further strengthen Spatial’s commitment to delivering high-performance solutions that optimize interoperability, data preparation, and advanced modeling workflows. Designed to improve efficiency and robustness across CAD translation, modeling, meshing, and simulation processes, the latest updates introduce expanded format support, enhanced PMI handling, and new capabilities for complex geometry processing. 3D InterOp NX Reader Enhancement for 2D Drawings The NX reader imports 2D drawings as visualization data from NX 2412 and later versions. glTF Writer Supports Draco Compression glTF export incorporates Draco compression for meshes and point-clouds to significantly reduce output file sizes. Enhanced Support for Reading Product Manufacturing Information
Meta Signs Agreement With AWS to Power Agentic AI on AWS Graviton Chips24.4.2026 15:10:00 EEST | Press release
Meta has signed an agreement to deploy AWS Graviton processors at scale. The deal marks a significant expansion of a long-standing partnership between the two companies as Meta builds its next generation of AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424641117/en/ The deployment starts with tens of millions of Graviton cores, with the flexibility to expand as Meta's AI capabilities grow. The deal reflects a shift in how AI infrastructure gets built: while GPUs remain essential for training large models, the rise of agentic AI is creating massive demand for CPU-intensive workloads—real-time reasoning, code generation, search, and orchestrating multi-step tasks. Graviton5 is purpose-built for these workloads, giving Meta the processing power to run them efficiently at scale. The chips will power various workloads at Meta, including supporting the company’s AI efforts. That work requires infrastructure that can handle
Meta Signs Agreement With AWS to Power Agentic AI on AWS Graviton Chips24.4.2026 15:10:00 EEST | Press release
Meta has signed an agreement to deploy AWS Graviton processors at scale. The deal marks a significant expansion of a long-standing partnership between the two companies as Meta builds its next generation of AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424641117/en/ The deployment starts with tens of millions of Graviton cores, with the flexibility to expand as Meta's AI capabilities grow. The deal reflects a shift in how AI infrastructure gets built: while GPUs remain essential for training large models, the rise of agentic AI is creating massive demand for CPU-intensive workloads—real-time reasoning, code generation, search, and orchestrating multi-step tasks. Graviton5 is purpose-built for these workloads, giving Meta the processing power to run them efficiently at scale. The chips will power various workloads at Meta, including supporting the company’s AI efforts. That work requires infrastructure that can handle
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