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
Backed by Investments Exceeding $1 Billion, PCI Pharma Services Announces Major Expansion of US Sterile Fill-Finish and Drug-Device Delivery Combination Capabilities27.4.2026 17:00:00 EEST | Press release
PCI Pharma Services (“PCI”) – a world-leading integrated global contract development and manufacturing organization (CDMO) focused on innovative biologic and small molecule therapies – announced a series of major infrastructure investments that substantially deepen its sterile fill-finish and advanced drug delivery capabilities. As pharma manufacturers and their development partners increasingly prioritize US supply chain resilience, PCI’s latest investments come as part of a broader commitment exceeding $1 billion across the CDMO’s US and European operations, reinforcing its ability to provide seamless support for drug product development and manufacturing, clinical trial supply and drug-device combination assembly from clinical stages through commercial launch – all underpinned by global capacity, technical expertise, deep scientific knowledge, and an industry-leading quality and regulatory track record. This press release features multimedia. View the full release here: https://www.
Pure Lithium Appoints Renowned Battery Expert Dr. Yuan Gao to Board of Directors27.4.2026 16:53:00 EEST | Press release
Pure Lithium Corporation, a vertically integrated lithium metal battery technology company, is pleased to announce that world-renowned inventor and battery expert Dr. Yuan Gao has joined the company’s Board of Directors. Dr. Gao has been an invaluable member of Pure Lithium’s Scientific Advisory Board since October of 2023. "We are thrilled to have Dr. Gao join our board as we focus on rapidly scaling our technology in the most capital efficient manner possible,” said Pure Lithium Founder, Chairman and CEO Emilie Bodoin. “Dr. Gao is a brilliant scientist who also has deep commercial expertise, a rare combination. He is also unique in the industry because his experience spans the entire battery materials value chain, including all of Pure Lithium’s verticals. His insights over the years have been critical in advancing our technology, and his experience as a director of public companies will strengthen our board.” Dr. Gao commented: “I am thrilled to join the board of Pure Lithium Corpor
Boomi To Unveil the Future Of Data Activation and AI-Driven Innovation at Boomi World 202627.4.2026 16:00:00 EEST | Press release
Boomi, the data activation company, today announced Boomi World 2026, its premier annual user conference, taking place May 11 - 14, 2026 in Chicago, IL. The event will bring together customers, partners, and industry leaders from around the world to explore how data activation is transforming the enterprise and accelerating the path to AI-driven outcomes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260427600340/en/ Boomi To Unveil the Future Of Data Activation and AI-Driven Innovation at Boomi World 2026 Boomi World 2026 will spotlight data activation — bringing data to life to power AI, analytics, and intelligent automation. Attendees will gain firsthand insights into how the Boomi Enterprise Platform enables businesses to unify data, streamline operations, and innovate faster in an increasingly agentic world. “Data is only valuable when it’s activated,” said Steve Lucas, Chairman and CEO, Boomi. “At Boomi World 2026, we
Axinn Appoints Rachael Philbin as Chief Innovation Officer27.4.2026 16:00:00 EEST | Press release
Axinn, Veltrop & Harkrider LLP today announced the appointment of Rachael Philbin as Chief Innovation Officer, reinforcing the firm’s continued investment in advanced solutions and technology for legal services delivery. Philbin joins from Proskauer Rose LLP, where she served as Innovation & Transformation Officer. Based in Axinn's New York office, she will lead the firm’s AI and legal technology initiatives as well as knowledge management efforts, accelerating adoption and integration across its antitrust, intellectual property, and litigation practices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260427277725/en/ Rachael Philbin joins Axinn, Veltrop & Harkrider LLP as Chief Innovation Officer. “As Axinn continues to grow, we are making deliberate investments in the capabilities that enable our lawyers to deliver service and results at the highest level in our clients’ complex matters,” said Jeny Maier, managing partner
Taiho Oncology, Taiho Pharmaceutical and Araris Biotech AG Advance ADC ARC-02 into Phase 1 Clinical Development27.4.2026 16:00:00 EEST | Press release
Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Araris Biotech AG (“Araris”) today announced that the U.S. Food and Drug Administration (FDA) has completed its Investigational New Drug (IND) review period for ARC-02, an antibody-drug conjugate (ADC) being developed for the treatment of non-Hodgkin lymphoma, enabling Taiho Oncology to initiate a Phase 1 dose-escalation clinical trial of ARC-02. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260427127507/en/ Taiho Pharmaceutical acquired Araris Biotech in March 2025, expanding Taiho group’s capabilities in biologics and ADC research and development. Araris is a spin-off of the Paul Scherrer Institute and ETH in Switzerland focused on the development of antibody-drug conjugates (ADCs). Central to Araris’ approach is its proprietary AraLinQ™ ADC technology, which enables the creation of stable and site-specific ADCs using standard antibodies with scalable manufacturing
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