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
DCX Launches Comprehensive ECDU Portfolio – Enterprise-Class Coolant Distribution Units From 600 kW to 2.6 MW11.3.2026 17:34:00 EET | Press release
DCX Liquid Cooling Systems today unveiled its new ECDU (Enterprise Coolant Distribution Unit) platform, a family of three purpose-built CDU models that deliver real cooling capacities from 600 kW to 2.6 MW in industry-standard rack and in-row footprints. The portfolio has been engineered specifically for the accelerating transition to direct-to-chip liquid cooling in high-density enterprise, colocation, cloud, and hyperscale AI environments where thermal stability, uptime, and cost-efficiency are non-negotiable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311214891/en/ DCX ECDU, the new generation of Enterprise Coolant Distribution Units dedicated to HPC and AI deployments. The lineup consists of: Enterprise ECDU 1380/2600 V1 - Delivers 1.38–2.6 MW of actual cooling capacity (based on real-world secondary-loop conditions). Single-pump configuration reaches flow rates up to 3,333 liters per minute (lpm). Mission Critica
Laserfiche Earns 5-Star Rating in the 2026 CRN® Partner Program Guide11.3.2026 16:00:00 EET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — has been honored by CRN®, a brand of The Channel Company, with a 5-Star Award in the 2026 CRN Partner Program Guide. This annual guide is an essential resource for partners seeking vendor partner programs that match their business goals and deliver high partner value. As organizations navigate growing pressure to increase productivity and respond to regulatory change, Laserfiche’s AI-powered document management solutions enable users to transform operations and achieve meaningful business results at scale. Partners that innovate with Laserfiche solutions have the opportunity to grow profits through the Laserfiche Partner Program, which equips them with the tools and resources needed to deliver customer success. Laserfiche’s partner ecosystem drives sustainable growth, delivers differentiated solutions and maximizes opportunities for both partners and their customers. Laserfiche provides comprehensive AI and clou
I-Pulse Launches iTerra Pulsed Power Solution for Weed Control Without Chemicals11.3.2026 15:30:00 EET | Press release
I-Pulse Co-Founder, Chairman, and CEO Robert Friedland, I-Pulse Co-Founder and Chief Technology Officer, Laurent Frescaline, and iTerra CEO, Romain Leray, are pleased to announce the launch of iTerra, an agricultural technology subsidiary dedicated to non-chemical weed control within I-Pulse, the world leader in pulsed power technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311080724/en/ iTerra leverages I-Pulse’s proprietary high pulsed power technology to eliminate weeds at the root without harming crops, disrupting soil microbiology, or leaving chemical residues. Using AI-driven detection with accuracy rates of up to 95% in early trials, the system targets each weed individually with controlled, high-energy pulses lasting just five milliseconds. The treated weeds remain in the soil, where they naturally decompose, helping maintain soil health and supporting long-term crop performance. I-Pulse Co-Founder, Cha
Andersen Consulting Strengthens Platform with Collaborating Firm Ambit Iberia11.3.2026 15:30:00 EET | Press release
Andersen Consulting expands its technology and business transformation capabilities through a Collaboration Agreement with Ambit Iberia, a consulting firm specializing in digital and regulatory solutions for the life sciences sector. Founded in 2003 and headquartered in Spain, Ambit Iberia provides integrated consulting, technology, and talent solutions for pharmaceutical, biotechnology, and medical device companies. The firm supports clients in meeting evolving quality, compliance, and regulatory standards through services spanning regulatory affairs, data integrity, IT system validation, and digital transformation. Leveraging more than 20 years of industry expertise, Ambit Iberia also offers human capital and executive search services that connect organizations with specialized professionals and senior talent, enhancing efficiency and driving sustainable growth in a highly regulated environment. “Our focus has always been on delivering specialized consulting and technology services t
Canva Introduces Magic Layers, Turning Static AI Outputs Into Editable Designs11.3.2026 15:00:00 EET | Press release
Canva, the world's leading all-in-one visual communication platform, today unveiled Magic Layers, a new breakthrough technology that turns any flat design or image into something you can edit, refine, and remix to suit your vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311951174/en/ Magic Layers is a new breakthrough technology that turns any flat design or image into something you can edit, refine, and remix to suit your vision. Generative AI has triggered a flood of visual content, but most of it remains locked in static image files. Even small changes can require starting over, with reprompts that can unintentionally alter the entire design. Powered by years of internal research and Canva’s growing investment in its AI development arm, Magic Layers ushers in a new era of editable content, where speed meets true creative control. Available in public beta today, it turns AI-generated content into a launchpad, no
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