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
Boomi Named a Leader and Secures Highest Score in the Strategy Category in Adaptive Process Orchestration Software Evaluation28.9.2026 18:45:00 EEST | Press release
Boomi™, the data activation company for AI, today announced it has been named a Leader in The Forrester Wave™: Adaptive Process Orchestration Software, Q3 2026. The report evaluated 13 providers, and Boomi achieved the highest score in the strategy category. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928931590/en/ Boomi Named a Leader and Secures Highest Score in the Strategy Category in Adaptive Process Orchestration Software Evaluation According to the report, Boomi’s “above-par roadmap is driven by a strong internal innovation process that embraces partner input and customer feedback, while recent investments focus on supporting client data sovereignty and control in geographies where sovereignty matters.” The report also cites Boomi's vendor-neutral control plane for agentic automation as allowing it to extend into the process automation market, an approach reinforced by recent acquisitions, such as Lunar.dev, an
Azalea Vision Enrolls First Patient in Proof-of-Concept Study Evaluating Novel Optical Aperture for Keratoconus and Presbyopia28.9.2026 17:27:00 EEST | Press release
Azalea Vision, a Belgian healthtech company building the first medical-grade smart contact lens, today announced that it has enrolled the first patient in its NOA proof-of-concept study. The study marks the start of Azalea’s clinical program, following its selection for the European Innovation Council (EIC) Accelerator. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928982998/en/ Novel Optical Aperture smart lens The study is conducted at Visser Contact Lenses (Netherlands) and the University Hospital Antwerp (UZA, Belgium). It evaluates a contact lens with a precisely positioned aperture, the optical principle at the core of Azalea’s adaptive smart lens, to reduce higher-order aberrations in keratoconus and to improve near vision in presbyopia. “For people living with keratoconus and presbyopia, better optical solutions can make a real difference in everyday life. We are proud to take part in this first clinical step and
CORRECTING and REPLACING SES Launches Cash Tender Offer28.9.2026 16:42:00 EEST | Press release
Please replace the release with the following corrected version due to multiple revisions to dates. The updated release reads: CORRECTING and REPLACINGSES Launches Cash Tender Offer THIS ANNOUNCEMENT RELATES TO THE DISCLOSURE OF INFORMATION THAT QUALIFIED OR MAY HAVE QUALIFIED AS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE MARKET ABUSE REGULATION (EU) 596/2014. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO OR TO ANY PERSON LOCATED OR RESIDENT IN, OR AT ANY ADDRESS IN, THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS (INCLUDING PUERTO RICO, THE U.S. VIRGIN ISLANDS, GUAM, AMERICAN SAMOA, WAKE ISLAND AND THE NORTHERN MARIANA ISLANDS), ANY STATE OF THE UNITED STATES OF AMERICA OR THE DISTRICT OF COLUMBIA (THE UNITED STATES) OR TO ANY U.S. PERSON (AS DEFINED IN REGULATION S OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT)) OR IN OR INTO ANY JURISDICTION WHERE IT IS UNLAWFUL TO RELEASE, PUBLISH OR DISTRIBUTE THIS ANNOUNCEMEN
Incognito Software Systems Launches NEXA, an AI-Enabled Solution for Automated Broadband Operations28.9.2026 16:00:00 EEST | Press release
Incognito Software Systems, a leading global provider of service orchestration, device management, and network intelligence solutions, today introduced NEXA, an AI-driven network intelligence and automation platform that enables broadband service providers to turn operational data into action. NEXA unifies network, device, service, and subscriber data in a single intelligence layer, delivering real-time and predictive insights that help service providers identify issues sooner, better understand the subscriber experience, and take faster, more informed action across their operations. As service providers seek to differentiate beyond connectivity, subscriber experience has become a critical competitive advantage. However, networks have evolved into complex service platforms that span access, edge, customer premises, apps, and third-party systems, making it difficult to detect and resolve issues quickly. NEXA addresses this challenge by combining cross-platform observability with AI-enab
Volante Technologies and Circle advance stablecoin payment and settlement capabilities for financial institutions28.9.2026 16:00:00 EEST | Press release
Volante Technologies, the global leader in Payments as a Service (PaaS), today announced a strategic collaboration with Circle Internet Group, Inc. (NYSE: CRCL) (“Circle”), a leading internet financial platform company and the issuer of USDC1 through its regulated entities, to help financial institutions integrate stablecoin payment and settlement capabilities into their existing payment operations. Through the collaboration, Volante is bringing USDC workflows into its AI-powered Payments Platform, enabling financial institutions to evaluate how stablecoin activity can operate alongside existing payment rails, operational controls, and on- and off-ramp requirements - without requiring a separate digital asset stack. Volante clients, which include four of the top five global corporate banks and seven of the top 10 U.S. banks, will be able to evaluate key workflows, including minting, redemption, beneficiary wallet registration, funding, notifications, and wallet-to-wallet payment execut
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