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
Modon Partners With Montage Hotels & Resorts to Bring Ultra-Luxury Hospitality Brand to Egypt’s Ras El Hekma17.5.2026 14:53:00 EEST | Press release
Abu Dhabi-based Modon Holding and Montage Hotels & Resorts have announced Montage Ras El Hekma, which will introduce the first branded residences for purchase at Ras El Hekma on Egypt’s Mediterranean coast. This is the first Montage resort in Egypt – supporting the emerging city’s growth as a global hub for leisure, business and tourism. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260517167234/en/ Modon partners with Montage Hotels & Resorts to bring ultra-luxury hospitality brand to Egypt’s Ras El Hekma (Photo: AETOSWire) Montage Ras El Hekma will feature 200 guestrooms and suites, in addition to 96 Montage Residences, and will offer a curated mix of wellness and leisure amenities, including beachfront swimmable lagoons, a Spa Montage with 13 treatment rooms, and six dining venues, alongside retail and family-oriented experiences. Designed as the experiential core of the wider community, the resort will also feature even
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Selects MEVION S250-FIT ™ for Southern Italy’s First Proton Therapy Center17.5.2026 09:00:00 EEST | Press release
Mevion Medical Systems, the global leader in compact proton therapy, today announced that it has been selected to deliver the MEVION S250-FIT Proton Therapy System™ to Istituto Nazionale Tumori IRCCS Fondazione G. Pascale in Naples. The award, made following a competitive European tender, will establish the first proton therapy center in Southern Italy, significantly expanding access to advanced radiation therapy for patients across the region and reducing the need for patients to travel long distances to northern Italy for care. Until now, proton therapy in Italy has only been available at centers located in Northern Italy, requiring patients from Southern Italy to travel significant distances for care. The Pascale project supports a broader strategy to establish Naples as a leading oncology hub and to improve healthcare equity across Italy. “The selection of the MEVION S250-FIT reflects our commitment to bringing advanced, accessible cancer care to patients in Southern Italy,” said D
TetraMem Announces 22nm Multi-Level RRAM Analog In-Memory Computing SoC Milestone16.5.2026 11:43:00 EEST | Press release
TetraMem Inc., a Silicon Valley–based semiconductor company developing analog in-memory computing (IMC) solutions, today announced the successful tape-out, manufacturing, and initial silicon validation of its MLX200 platform, a 22nm multi-level RRAM-based analog IMC system-on-chip (SoC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260516556464/en/ Photograph of the MLX200 chip with a five-cent coin for size reference The achievement marks a significant step toward the commercialization of analog computing architectures based on emerging non-volatile memory technologies, addressing the growing challenges of data movement, power consumption, and thermal constraints in modern AI systems. As AI workloads continue to scale, system performance is increasingly constrained by the cost of moving data between memory and compute units. Analog in-memory computing offers a fundamentally different approach by performing computation dir
NTT DATA Announces Intent to Acquire WinWire to Scale Enterprise AI Adoption and Accelerate Industry Transformation with Microsoft15.5.2026 19:36:00 EEST | Press release
NTT DATA, a global leader in AI, digital business and IT services, today announced it has signed a definitive agreement to acquire WinWire,an award-winning Microsoft partner specializing in Agentic AI, AI on Azure, data engineering and cloud-native development as foundational capabilities for enterprise AI. The acquisition strengthens NTT DATA’s position as a trusted partner to help organizations move beyond experimentation to operationalize AI at scale. The acquisition further advances NTT DATA’s enterprise AI strategy as demand accelerates for AI-driven, cloud-native transformation. By expanding capabilities across data platforms, agentic AI and modern applications, NTT DATA is sharpening its ability to deliver production-ready AI solutions aligned to industry needs, reinforcing its leadership as Microsoft’s Global System Integrator (GSI) Growth Champion Partner of the Year. Upon closing, WinWire will add more than 1,000 skilled Azure engineers and Microsoft specialists to NTT DATA,
STARTEEPO Invest Announces 5% Stake in Xerox Holdings Corporation15.5.2026 19:15:00 EEST | Press release
STARTEEPO Invest (“STARTEEPO”), an alternative investment fund focused on public equity opportunities, today announced that it has acquired a significant ownership position in Xerox Holdings Corporation (“Xerox” or the “Company”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515594020/en/ As of the date of this release, STARTEEPO and its affiliates beneficially owns 6.6 million shares of Xerox (excluding options), representing approximately 5.05% of the Company’s outstanding common stock. STARTEEPO has filed a Schedule 13D with the U.S. Securities and Exchange Commission (the “SEC”) providing additional details regarding its investment. Investment Perspective STARTEEPO believes that Xerox represents an interesting investment opportunity supported by a combination of balance sheet initiatives, ongoing operational improvements, and its position within a changing and consolidating industry. In STARTEEPO’s view, the Company
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