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
NEG Develops “BDX-3,” a New Starveil™ Ultra-thin Cover Glass for a Wider Range of Space Environments6.10.2026 04:00:00 EEST | Press release
Nippon Electric Glass Co., Ltd. (NEG) (TOKYO: 5214) has developed “BDX-3,” a new Starveil™ ultra-thin cover glass for space applications. BDX-3 is designed to reduce radiation-induced discoloration while providing greater ultraviolet (UV) shielding performance than BDX-2. While primarily intended for low Earth orbit (LEO), it can also be used in medium Earth orbit (MEO) and high Earth orbit, making it suitable for a wider range of space environments. Samples are now available for purchase, and NEG aims to achieve commercial adoption of BDX-3 in satellites and other spaceborne equipment. About BDX-3 Satellites and other equipment operating in space are exposed to intense UV radiation and other forms of radiation. Low Earth orbit is widely used for Earth observation and communications, medium Earth orbit for positioning systems, and high Earth orbit for communications and weather observation. Cover glass used in these environments must not only protect precision equipment from harsh cond
AM Intelligence Expands NVIDIA Vera Rubin AI Factory Buildout in India and Malaysia5.10.2026 21:16:00 EEST | Press release
AM Intelligence (“AMI”), the AI infrastructure platform set up by Promoters of Greenko, today announced two further firm and binding orders for 20,000 NVIDIA Rubin GPUs, to be deployed as NVIDIA Vera Rubin NVL72 rack-scale systems. Building on its first AI factory in Hyderabad, the expansion is designed to give cloud providers, enterprises and AI developers access to large-scale computing capacity closer to where they build and deploy AI. These orders are in addition to the AMI's inaugural commitment announced on August 25, 2026, for 9,000 NVIDIA Rubin GPUs at its first AI Factory in Hyderabad. This follow-on capacity totalling ~70 megawatts (MW) will be deployed at Malaysia and India with delivery scheduled for Q2 2027. Taken together, the three orders bring AMI's committed frontier compute to approximately 29,000 Rubin GPUs and close to 100 MW of capacity, establishing AMI among the earliest and largest committed buyers of Rubin GPUs outside of North America. AMI plans to bring addit
SES Announces Final Results of Its Cash Tender Offer5.10.2026 20:49:00 EEST | Press release
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 ANNOUNCEMENT. SES (the “Offeror”) announces today the final results and pricing of its invitation to holders of its outstanding €500,000,000 0.875 per cent. Guaranteed Notes due 4 November 2027
Cessna Skyhawk Veris Virtual Reality Flight Training Device to Make Show Debut at NBAA-BACE in Las Vegas5.10.2026 18:00:00 EEST | Press release
TRU Simulation + Training Inc., a Textron Inc. (NYSE:TXT) company, and an affiliate of Textron Aviation, announced today its Veris Virtual Reality Flight Training Device (FTD) configured for the Cessna Skyhawk is making its show debut at the 2026 National Business Aviation Association Business Aviation Convention & Exhibition (NBAA-BACE). The show debut builds on momentum from NBAA-BACE 2025, where TRU Simulation announced a purchase agreement with US Aviation Academy for five Cessna Skyhawk Veris devices, with options for additional units. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005927782/en/ Cessna Skyhawk Veris Virtual Reality Flight Training Device to make show debut at NBAA-BACE in Las Vegas This year, NBAA-BACE attendees will have the opportunity to experience the Cessna Skyhawk Veris first-hand through live demonstrations at booth #3415 and learn how immersive virtual reality technology can enhance pilot rea
FuzeBox AI Named Founding Co-Author of SPUR Coalition Technical Committee on Verifying AI Content Use5.10.2026 16:00:00 EEST | Press release
FuzeBox AI has been named by the SPUR Coalition, an international nonprofit of 37 news and media organizations, as one of four founding co-authors of its Evidence Profile Technical Committee, adopted Sept. 2, 2026, to draft an evidence profile for SPUR's Content Telemetry standard: a way for publishers to verify AI usage reports without depending on the reporting company's cooperation. Under SPUR's current standard, AI companies self-report their content use. A company that skips reporting leaves no record, and publishers can't check what they do receive. On July 10, 2026, FuzeBox proposed its Verified Provenance Telemetry Standard (VPTS): publishers seed content with detectable markers, then verify their appearance in AI outputs via an auditable ledger, with no change to SPUR's standard. Within 48 hours, three organizations filed related proposals: ProRata on usage magnitude, Encypher CEO Erik Svilich on the verification question FuzeBox raised, and LicenseFoundry on portable proof of
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