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
Rapid Medical™’s DISTALS Trial Overwhelmingly Positive, Demonstrating Superior Reperfusion with TIGERTRIEVER™ 13 in Medium Vessel Stroke6.2.2026 21:30:00 EET | Press release
Rapid Medical™, a leading developer of active endovascular devices, today announced late-breaking results from the DISTALS multicenter, randomized controlled trial showing that TIGERTRIEVER™ 13 achieved superior brain tissue reperfusion with an excellent safety profile when compared with medical management in medium vessel occlusion (MVO) stroke. The findings were presented in the main closing session at the 2026 International Stroke Conference (ISC). Top-line results showed that the TIGERTRIEVER™ 13 arm demonstrated 3x more successful reperfusion without symptomatic intracranial hemorrhage (sICH) compared to medical management–86.3% vs 27.7% (p < 0.001). Notably, zero sICH events were reported in the randomized treatment arm treated with TIGERTRIEVER 13. By comparison, sICH rates reported with intravenous thrombolysis alone are higher, ranging from 2 – 6% in contemporary trials.1,2,3 “These results highlight what is possible when both the device and the trial are designed specifically
Al Barari Breaks Ground on The Cape, The Final Chapter of a Legacy6.2.2026 16:46:00 EET | Press release
Al Barari, Dubai’s pioneering nature-led community, has officially marked the groundbreaking of The Cape, its final signature residential development, celebrating two decades of visionary craftsmanship and a continued commitment to creating harmonious living environments rooted in nature. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260206475199/en/ Hazza Zaal, CEO of Al Barari Real Estate Group, alongside the Sales and Construction teams at The Cape Groundbreaking Ceremony, marking a milestone in Al Barari’s final signature development. (Photo: AETOSWire) The milestone ceremony signals the beginning of a landmark chapter for Al Barari, as The Cape represents the culmination of a 20-year legacy defined by intentional design, wellbeing-focused living, and immersive natural landscapes. Located within Dubai’s green heart, The Cape introduces an enriched lifestyle experience surrounded by lush botanical settings, gentle water
Quantfury and Sandwich Launch Commercial Series to Encourage Better Choices in Retail Trading6.2.2026 16:00:00 EET | Press release
Quantfury Trading Americas Limited (“Quantfury”), a global brokerage offering commission-free trading at real-time spot prices from major exchanges, has partnered with Sandwich, a leading creative agency for tech and product videos, to produce a Social Responsibility Commercial Series. The series of commercials incorporates clear, engaging storytelling to prompt viewers to think about common retail trading behaviors—especially high-energy marketing, gamification of speculation, and heavy focus on potential gains without equal attention to risks—and to choose more thoughtful, informed approaches. Lev Mazur, Founder of Quantfury, said: “It’s a pleasure to work with Sandwich, whose visual storytelling is outstanding. Since day one, Quantfury has aimed to question and improve the standard practices in the global retail trading industry.” Adam Lisagor, Founder of Sandwich, added: “A good investment is a story. Quantfury stood out by wanting to tell a real, interesting story first—rather tha
JSS: 2025 Sake Exports Grew Steadily, Reaching a Record 81 Markets6.2.2026 05:00:00 EET | Press release
Sake exports continued to expand in 2025 in both value and volume, with export destinations reaching a record 81 countries and regions. Export value increased 6% year on year to 45.9 billion yen, while export volume rose 8% to 33.55 million liters (3.73 million cases on a 9-liter basis), marking the second-highest export performance on record. The average export unit price per 750 ml bottle declined 2% year on year to 1,026 yen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205671686/en/ Sake Export Performance by Country (Top 10, 2025) Export value has nearly doubled since 2020, and the CAGR over the past five years reached 14%. This underscores sake’s position as a high-growth category globally. Asia remained the largest export destination, with export value totaling 28.8 billion yen, representing an 8% increase year on year and accounting for 63% of total export value. North America recorded exports of 12.4 billion ye
Canva Brings On-Brand Designs Directly into AI Assistants6.2.2026 01:00:00 EET | Press release
The future of work is being rewritten by AI, with professionals accomplishing in minutes what used to take hours. But there's been one persistent breaking point in AI assistants: generic visual outputs and off-brand colors that undermine AI speed with tedious manual cleanup. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205384226/en/ Canva Today, that friction ends as Canva brings brand intelligence directly into the AI tools where modern day work happens most. Starting now, ChatGPT users can create designs completely tied to their Canva Brand Kit, making a company’s brand come to life visually and function as a living participant in AI workflows. This expansion marks the coming together of Canva and ChatGPT, two category-defining platforms, in a new way to make on-brand design more accessible and fluid. From client-ready pitch decks to social posts and professional-looking posters, the partnership continues to fuel Canv
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