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
SES Advances Next-generation MEO Strategy Following Successful Completion of IRIS² Rendez-vous 17.8.2026 11:52:00 EEST | Press release
SES today announced the successful completion of Rendez-vous 1 (RDV1) under the Infrastructure for Resilience, Interconnectivity and Security by Satellite (IRIS²) programme, marking a key milestone in the programme's implementation phase and reinforcing Europe's path towards sovereign, resilient and secure satellite connectivity. The successful completion of RDV1 confirms the programme's readiness to move forward with implementation and provides greater visibility on the long-term scope, performance and economics of the MEO segment. SES's expected capital commitment for the MEO segment is up to €1.35 billion, reflecting current programme scope, while maintaining the deployment of 18 MEO satellites and the targeted service entry in 2030. SES’s share of the investment in the IRIS² programme for 2026 is included in SES’s FY26 Capex outlook as previously communicated. No future exceptional cash proceeds will be used to fund the project. Since the signing of the IRIS² Concession Contract in
Allianz Delivers Record Result and Is Well on Track to Achieve Its Targets7.8.2026 08:10:00 EEST | Press release
2Q 2026 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806509750/en/ Oliver Bäte, Chief Executive Officer of Allianz SE Total business volume at 45.6 billion euros, an internal growth of 5.7 percent1, with contributions from all segments. Asset Management delivers excellent growth. Operating profit rises 10.6 percent to a record level of 4.9 billion euros. Shareholders’ core net income at 2.6 billion euros; 12.7 percent below last year. Adjusted for a divestment gain last year and offsetting measures following the sale of the stake in our Indian JVs, underlying growth is strong at 10 percent. 6M 2026 Total business volume at 98.6 billion euros, an internal growth of 4.3 percent1, driven by Property-Casualty and especially Asset Management. Operating profit rises 8.6 percent and reaches a record level of 9.4 billion euros. Shareholders’ core net income advances 15.5 percent to 6.4 billion euros. Adjusted for divestment eff
Pure Lithium Receives Australian Patent for "Lithium Metal Anode and Battery"6.8.2026 23:49:00 EEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery technology company, today announced that the Australian patent office has granted the company a patent (AU2025271196) titled “Lithium metal anode and battery.” Australia mines roughly half of the world’s lithium, yet has no domestic battery production at all; every battery the country uses is imported. The granted patent is directed to ways in which Pure Lithium’s technology can change that. Rather than trying to catch up in lithium-ion, Australia can leapfrog the incumbent technology and establish a next-generation industry. As worldwide demand for batteries grows, every country capable of making batteries needs to be making them. That is Pure Lithium’s central goal: opening up markets around the world through battery technology that enables local, independent supply chains, keeping pace with demand and strengthening economies. China controls the lithium-ion battery supply chain and manufactures th
Vercel Appoints Amit Agarwal, Standard Template Labs CEO and former Datadog President, to Board of Directors6.8.2026 18:00:00 EEST | Press release
Vercel, the agentic infrastructure company, today announced the appointment of Amit Agarwal, former president of Datadog and founder and CEO of Standard Template Labs, an AI-first service management platform, to its board of directors. Agarwal brings 25 years of enterprise software experience and a track record of scaling a product-led company from its earliest days into one of the defining public software companies of the cloud era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806738617/en/ Amit Agarwal Agarwal joined Datadog in 2012 as its Chief Product Officer and was named President in 2022, overseeing product, corporate development, and go-to-market functions as the company grew past $2.5 billion in annual revenue. Across 13 years, including Datadog's 2019 IPO and its first years as a public company, Agarwal helped build one of the industry's most studied examples of product-led growth at enterprise scale. He conti
Laserfiche Launches Advanced Enterprise Security to Deliver Multi-Region Disaster Recovery and GovRAMP-Ready Compliance for Highly Regulated Industries6.8.2026 17:00:00 EEST | Press release
Laserfiche — the leading SaaS provider of intelligent content management — today announced the launch of Enterprise Security, an advanced suite of security enhancements designed for organizations navigating complex regulatory environments. Enterprise Security addresses GovRAMP and CJIS (Criminal Justice Information Services) security requirements based on the NIST SP 800-53 framework. For organizations handling privileged citizen, legal or corporate data, these built-in controls streamline audit preparation and fortify defenses. With organizations placing a higher priority on data stewardship and corporate governance, enterprise IT leaders require a security architecture that protects data without slowing down operations. Laserfiche Enterprise Security extends Laserfiche Cloud’s highly resilient infrastructure with multi-region data replication, elevated security controls for privileged accounts, and built-in governance safeguards. “Maintaining data integrity and compliance has always
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