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
Grid Dynamics Appoints Industry Veteran Nikita Ivanov as Head of AI26.8.2026 23:05:00 EEST | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, is advancing its AI strategy under the leadership of Nikita Ivanov, Vice President, Head of AI. Ivanov is responsible for leading the transition efforts of Grid Dynamics’ clients toward an AI-native software delivery model, and he oversees all elements of Grid Dynamics AI Native (GAIN) platforms. Ivanov brings more than two decades of experience founding and leading technology companies to his role as Vice President, Head of AI. He founded and led GridGain, a distributed computing company built for in-memory data processing. During his 15-year tenure at GridGain, Ivanov also founded the natural language processing framework Apache NLPCraft and, later, Humatron AI, an AI workforce platform. He then served as Field CTO for GenAI at DataStax. That same pattern of building foundational tools now runs through Grid Dynamics’ own AI-SDLC tools, Allium, Rosetta, and SpecFlow
Arc'teryx Introduces System 0™, a New Framework for the Future of Product Design and Circularity26.8.2026 16:00:00 EEST | Press release
Arc'teryx Equipment, the global design company specializing in technical high-performance apparel and equipment, today introduced System 0™, a new framework that reimagines how products can be designed, manufactured, used, repaired, and ultimately regenerated. System 0 represents the next evolution for sustainability in the outdoor industry, as it embeds circular thinking across an entire product lifecycle while maintaining the uncompromising performance standards that define the Arc’teryx brand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260826686539/en/ Arc’teryx athlete, Craig Murray, wearing the Sperro SV, a multisport mountain-grade hardshell built with circular design principles, available September 4, 2026. The first product being introduced as part of the System 0 platform is the Sperro SV jacket, a multisport mountain-grade hardshell engineered for durability, repairability, and disassembly at end of life – the
Xsolla Announces Five-Year Partnership With the Global Esports Federation26.8.2026 16:00:00 EEST | Press release
Xsolla, a global commerce company, today announced a landmark five-year strategic partnership with the Global Esports Federation (GEF), the world-convening body for esports. As GEF's exclusive partner for commerce, payments, wallet, loyalty, and distribution, Xsolla will power the entire GEF ecosystem, including the flagship Global Esports Games, pro-series Global Esports Tour, global GEFcon, and 180+ Member Federations across five continents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260826948844/en/ Graphic: Xsolla The announcement comes as GEF marks 100 days to go to the Los Angeles 2026 Global Esports Games (GEGLA26), adding further momentum to the road to Los Angeles and GEF’s flagship global esports celebration this December. The partnership launches at the GEGLA26, where Xsolla will begin serving as the unified commerce and payments layer for the GEF ecosystem. Across GEF properties, in more than 200 markets, Xso
FlightSafety International Reaches Agreement to Acquire Acron Technologies’ Commercial Training Solutions26.8.2026 16:00:00 EEST | Press release
FlightSafety International Inc. (FSI), a leading global provider of aviation training and simulation technology, today announced it has signed a definitive agreement with Acron Technologies, a portfolio company of TJC LP, to acquire its Commercial Training Solutions (CTS) business, including its Training Systems, Training Services, Aviation Academy, and Driver Training portfolio. The agreement marks a significant expansion of FSI’s capabilities in the commercial aviation market, broadening and complementing its simulator manufacturing capabilities and global training footprint. CTS brings over eight decades of experience in commercial aviation training and simulation. With a long-standing heritage in commercial airline simulator manufacturing, CTS has delivered more than 850 training devices throughout its history, with over 300 full-flight simulators currently in operation worldwide today. Its training and manufacturing locations across the U.S., U.K., and Thailand support pilot and d
NABEP Appoints Sara Chouraqui as General Counsel26.8.2026 16:00:00 EEST | Press release
North American Blue Energy Partners (NABEP) has appointed Sara Chouraqui as General Counsel, with Elizabeth Collery and Victoria Jacobson each joining as Deputy General Counsel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260826168543/en/ Sara Chouraqui joins NABEP as its General Counsel, bringing decades of legal expertise. These additions significantly strengthen NABEP’s senior leadership team and legal expertise as the company improves its operations, increases production and develops new strategic and commercial partnerships. As General Counsel, Chouraqui will lead NABEP’s global legal function and advise the company’s leadership on its legal, regulatory and corporate priorities, including major transactions and partnerships, governance, compliance and the management of legal and regulatory risk across the company’s operations. Her experience navigating complex cross-border legal and regulatory matters will be particu
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