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
Arini Announces Final Close of Inaugural Direct Lending Fund, Targeting Over $4 Billion of Deployment21.10.2026 10:00:00 EEST | Press release
Arini, an alternative asset manager with $22 billion in assets under management as of 31 August 2026, today announces the final close of Arini Direct Lending Fund I. The Fund and related vehicles are targeting deployment of over $4 billion, including anticipated leverage, making it among the largest debut European direct lending funds ever raised. Arini has built a sizeable initial portfolio throughout the fundraise, focusing on senior secured loans to borrowers demonstrating recurring and underwritable cash flow profiles and operating in industries with limited risk of disruption. Total deployment for the strategy is now approaching $2 billion across a range of sectors and geographies, alongside founder-led, family-owned and sponsor-backed businesses. This scale of deployment, in conjunction with Arini’s highly selective underwriting standards, demonstrates the depth of the European middle market opportunity set. Unlike in the US, banks in Europe have a dominant market share in corpor
Skechers Wins Major Victory Against Kizik in Patent Infringement Suit21.10.2026 10:00:00 EEST | Press release
Skechers U.S.A., Inc. (“Skechers”), the third largest footwear company in the world and leader in hands-free footwear technology, announced today that it won a major legal and commercial victory in a patent infringement lawsuit filed by Fast IP, LLC (“Kizik”) against Skechers before the Unified Patent Court (“UPC”) in Munich. Skechers, the market leader in hands-free footwear, sells thousands of styles of hands-free shoes worldwide under its Slip-ins and Swift Fit trademarks. In 2025, Kizik sued Skechers at the UPC for alleged patent infringement involving four of its thousands of hands-free styles. Skechers won on three of the four styles, with the fourth being a minor and commercially insignificant style for Skechers. In its ruling, the Munich Court stated that Kizik’s infringement claims are “largely unfounded.” Skechers’ leading hands-free footwear position globally is the result of its product innovation, transforming the century-old idea of hands-free footwear into a true modern
LemFi Launches Its Biggest Product Expansion Yet Alongside a New Global Brand, ‘Ambition has no passport’21.10.2026 10:00:00 EEST | Press release
LemFi, the financial platform for people building lives across borders, today announced the launch of its new global brand platform, “Ambition has no passport”, alongside a completely rebuilt app, launching the largest product expansion in its history. More than two million customers use LemFi to move money to more than 30 countries, with over $2 billion in monthly transaction volume, and the company plans to add more countries next year. The expanded platform now includes savings and credit in the UK, eSIMs in more than 100 destinations, alongside LemFi’s existing international payments service. People who move countries arrive with a career, a qualification and a savings record, only to find that almost none of it counts. A credit history rarely survives a border crossing. Around 304 million people now live outside the country where they were born, sending some $905 billion home each year. Yet many financial services remain designed around individual products or customers living thei
AI and Multichannel Communication Come to Italian Municipalities21.10.2026 10:00:00 EEST | Press release
ANCIcomunicare and Audiencerate are partnering to provide Italian municipalities and local authorities with a new platform dedicated to data management and multichannel communication. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019549522/en/ ANCIcomunicare and Audiencerate launch a partnership to bring Italian municipalities a platform that simplifies data management and digital communication with citizens across all channels. The solution enables municipalities to manage, through a single digital system, communication campaigns aimed at citizens and businesses across multiple channels, including WhatsApp, SMS and e-mail. The platform also integrates Artificial Intelligence and Microsoft Copilot capabilities, designed to simplify content creation, campaign management and the personalization of communications. A solution designed for municipalities. The project aims to make advanced digital tools available to local auth
Okomera Announces a Commercial Agreement With Servier to Use Its Tumor Miniaturization Technology for Cancer Research21.10.2026 09:00:00 EEST | Press release
Okomera, a TechBio company pioneering personalized cancer care through a proprietary technology platform combining tumor mini-avatars, microfluidics, and AI-powered imaging, today announced the signing of a commercial agreement with Servier, an independent international pharmaceutical group, to use its technology in the development of new cancer treatments. With more than 90% of oncology drug candidates never reaching the market, identifying early on the therapeutic approaches most likely to succeed is a critical challenge for the pharmaceutical industry. Okomera’s technology helps precisely reduce this attrition, by steering development toward candidates that demonstrated real, measurable activity against tumors. This collaboration marks an important milestone for Okomera, which is signing its first commercial agreement with an international pharmaceutical group. Under the terms of the agreement, Servier will operate Okomera’s platform fully independently. Its teams will be able to ge
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