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
LR Health & Beauty Strengthens Its Management Team With Martin Lipp as New Chief Financial Officer (CFO)7.9.2026 16:36:00 EEST | Press release
The LR Health & Beauty GmbH, Europe’s leading social commerce company for high-quality nutritional supplements and beauty products, is strengthening its management team: effective 7 September 2026, Martin Lipp takes over as Chief Financial Officer (CFO) and joins the Executive Management Team. In his new role, Martin Lipp will be responsible for Global Controlling & Finance, Legal, IT and Operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907262360/en/ Martin Lipp, new CFO of the LR Group “With Martin Lipp, we are gaining a highly experienced international finance executive with extensive expertise in managing and transforming businesses. During the current transition phase, he will enrich the senior management in particular with his strong transformation expertise and excellent know-how in the areas of finance, operations and IT. Together, we will consistently drive forward the implementation of our strategy with
Capcom’s Onimusha: Way of the Sword Sells Over 1 Million Units on Launch Day!7.9.2026 16:00:00 EEST | Press release
Capcom Co., Ltd. (TOKYO:9697) today announced that worldwide sales of Onimusha: Way of the Sword, the latest title in the series, have surpassed 1 million units on the first day of its release. Driven by the performance of this title, cumulative sales of the Onimusha series have now surpassed 10 million units. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907554827/en/ Onimusha: Way of the Sword key art Onimusha: Way of the Sword, which marks the first new title in the series in over 20 years, is a swordplay action game featuring protagonist Miyamoto Musashi that is set in Edo-era Kyoto. This title enhances the exhilarating sword-based action of the series with cutting-edge technology while also providing a compelling story and beautiful visual depictions. In addition, through several marketing initiatives prior to launch, such as multiple demo releases and hands-on exhibitions, Capcom worked to expand awareness among a
A2RL Sets New International Benchmark with Europe’s First Five-Car Autonomous Race7.9.2026 15:16:00 EEST | Press release
The Abu Dhabi Autonomous Racing League (A2RL) completed the first-ever multi-car autonomous race in Europe at the Imola Circuit in Italy on 5 September 2026, as part of ACI Racing Weekend. Kinetiz (UAE) won the League’s inaugural international race, across 12 laps of one of the most technically demanding circuits in world motorsport. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907943650/en/ A2RL Sets New International Benchmark with Europe’s First Five-Car Autonomous Race (Photo: AETOSWire) Organised by ASPIRE, the grand challenges arm of Abu Dhabi’s Advanced Technology Research Council (ATRC), A2RL brings together key players across Abu Dhabi’s autonomous mobility ecosystem, with strategic oversight from the Smart and Autonomous Systems Council (SASC). A2RL has evolved from a public testbed for AI under extreme race conditions into a competitive racing series. Imola marked the League’s first international chapter foll
Dubai Chambers to Train 14,000 Private Sector Companies in Agentic AI7.9.2026 13:15:00 EEST | Press release
Dubai Chambers has launched specialised Agentic AI training for more than 14,000 private sector companies, helping businesses build the skills needed to adopt the technology across their operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907193930/en/ H.E. Eng. Sultan bin Saeed Al Mansoori speaking during the launch of the training programme (Photo: AETOSWire) The training forms part of Dubai’s wider programme to transition the private sector towards Agentic AI, launched under the directives of H.H. Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, Crown Prince of Dubai, Deputy Prime Minister and Minister of Defence of the UAE, and Chairman of The Executive Council of Dubai. Delivered through the new Dubai Chambers Academy, an integrated e-learning platform, the training provides practical guidance on applying Agentic AI in business. Participants will explore tools and solutions that can improve operations, effici
REPLY: A Face Only A Mother Could Love by Robert Gaudette Wins the Reply AI Film Festival 2026, the International Competition Exploring the Intersection of Cinema and Artificial Intelligence7.9.2026 13:02:00 EEST | Press release
Canadian filmmaker Robert Gaudette, with his short film A Face Only A Mother Could Love, has won the Reply AI Film Festival 2026, the international competition created by Reply to explore new frontiers in cinematic language through the use of artificial intelligence. The award was presented on Sunday 6 September in Venice, during a ceremony organised by Reply and Mastercard at the Match Point Arena, set up at Tennis Club Venezia on the Lido, alongside the 83rd Venice International Film Festival. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907478421/en/ Canadian filmmaker Robert Gaudette, with his short film A Face Only A Mother Could Love, has won the Reply AI Film Festival 2026, the international competition created by Reply to explore new frontiers in cinematic language through the use of artificial intelligence. Now in its third edition, the Reply AI Film Festival received more than 3,000 short films from 76 countri
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