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
Kingswood Capital Management Raises $4 Billion Across Two Oversubscribed Middle-Market Funds30.7.2026 18:00:00 EEST | Press release
Kingswood Capital Management, L.P. (together with its affiliates, “Kingswood”), a Los Angeles-based investment firm focused on the middle-market, today announced the final closing of Kingswood Capital Opportunities Fund IV, L.P. (together with its parallel fund, “Fund IV”), with total capital commitments of $3.1 billion, as well as Kingswood Capital Opportunities Small Cap Fund I, L.P. (together with its parallel fund, “Small Cap Fund I”), with total capital commitments of $900 million. These funds more than double Kingswood’s total assets under management (“AUM”) to over $7 billion. Fund IV represents the fourth institutional fundraise in five years for Kingswood and is more than double the size of Fund III. Both Fund IV and the inaugural Small Cap Fund I were significantly oversubscribed in just five weeks. Fund IV exceeded its initial target of $2.25 billion, while Small Cap Fund I exceeded its initial target of $550 million and both closed at their hard caps. The successful fundrai
CyrusOne Names John Hatem Chief Executive Officer to Accelerate its Global Digital Infrastructure Strategy30.7.2026 16:30:00 EEST | Press release
CyrusOne (the “Company”), a leading global data center owner, developer and operator, today announced the appointment of John Hatem as Chief Executive Officer and a member of the Company’s Board, effective immediately. As part of the Company’s long-term succession planning, Eric Schwartz, who successfully led CyrusOne through a period of significant expansion, is stepping down as CEO and will work together with Hatem to ensure a smooth transition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730005910/en/ John Hatem Hatem joined CyrusOne in 2011 and has held a series of increasingly senior roles across the business. He most recently served as President, responsible for global sales, global procurement, and design, engineering, and construction in the United States. His deep experience in data center design, development, and operations has helped transform CyrusOne into one of the world’s leading digital infrastructure p
Mary Kay Releases 2026 Sustainability Report Highlighting Transformative Progress Across Social, Economic, and Environmental Impact Globally30.7.2026 15:03:00 EEST | Press release
Mary Kay Inc., a leading global beauty company committed to sustainability and women’s empowerment, today released its 2026 Sustainability Report, outlining progress toward its 2030 goals and celebrating the 2025 and latest achievements that continue to drive positive change globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730240667/en/ Mary Kay's annual 2026 Sustainability Report highlights the company's decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose-driven legacy rooted in Mary Kay's mission of “enriching women’s lives” around the world. (Image Credit: Mary Kay Inc.) The annual report highlights Mary Kay’s decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose-driven legacy rooted in the company’s mission of “enriching women’s lives”
Veracode Launches “Veracode Marketplace”: A Curated Ecosystem of Elite Security Integrations Built for the AI-Powered Software Development Era30.7.2026 15:00:00 EEST | Press release
Veracode, the global leader in application risk management, today announced the launch of the Veracode Marketplace, a curated ecosystem that gives customers a single, trusted destination to discover, evaluate, and deploy third-party security integrations as an extension of the Veracode platform. The marketplace debuts with DryRun Security as its inaugural partner, delivering AI-native contextual analysis and verification to Veracode customers on day one. A New Standard for the AppSec Ecosystem The Veracode Marketplace enables security and engineering teams to extend their existing Veracode investment with validated, best-in-class integrations. Every partner is vetted for technical depth, product quality, and workflow fit. Integrations are anchored to Veracode findings for a unified audit trail, and every purchase goes through a single procurement path on a single contract, with a personalized support experience. “Application security has entered a new era, and no single vendor will sol
INNIO Awarded EcoVadis Platinum Medal for Fifth Consecutive Year30.7.2026 15:00:00 EEST | Press release
INNIO N.V. (Nasdaq: INIO) has been awarded the EcoVadis Platinum Medal, the highest recognition granted by the globally trusted provider of business sustainability ratings. This marks the fifth consecutive year that INNIO has achieved Platinum status since 2022. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730309718/en/ INNIO N.V. Awarded EcoVadis Platinum Medal for Fifth Consecutive Year In the latest assessment cycle, INNIO further improved its overall EcoVadis score compared to the previous year by introducing additional policies and further strengthening its sustainability management system. “This recognition is a strong validation of our sustainability strategy,” said Marcin Kawa, Vice President Sustainability at INNIO. “Achieving EcoVadis Platinum status for the fifth consecutive year shows that we have consistently delivered on our sustainability commitments and embedded responsible business practices throughout
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