Thermo Fisher Scientific Certifies Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System to Meet IVDR Requirements
12.9.2022 09:30:00 EEST | Business Wire | Press release
Thermo Fisher Scientific has certified the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System* to meet new In Vitro Medical Devices Regulation (IVDR) requirements. The updated system now includes new, complementary Applied Biosystems Diomni Software ecosystem to empower clinical labs and test developers to leverage flexible PCR testing onsite.
Designed for maximum productivity and fast ramp-up, the QuantStudio 7 Pro Dx Real-Time PCR System enables users to transition from development to validation on a single system. The expandable, automated platform comes with interchangeable 96-well and 384-well blocks and also includes remote desktop and touchscreen controls, facial authentication, voice command and smart tech support to increase user productivity.
“We have continued to support our customers throughout the transition to IVDR, first by introducing the updated Applied Biosystems QuantStudio 5 Dx Real-Time PCR System earlier this year and now with the launch of the IVDR-compliant QuantStudio 7 Pro Dx Real-Time PCR System and new complementary Diomni Software ecosystem,” said Fernando Beils, vice president and general manager of qPCR instruments at Thermo Fisher Scientific. “As test developers and laboratories expand their assay menus and IVD testing capabilities, we are committed to continue providing innovative solutions to meet their evolving needs.”
Whether performing a routine test or developing a new assay, the integrated, IVDR-compliant Applied Biosystems Diomni Software ecosystem is designed to streamline the entire workflow with a plug-and-play design and simplified set-up to enhance efficiency and minimize user error. The centralized set-up allows connection to multiple real-time PCR instruments and secure data sharing across a user network.
“The ability to import plate set-up files from external software and export result sets in a customizable structure made it easy to integrate the QuantStudio 7 Pro Dx Real-Time PCR System with our laboratory information management software,” said Dr. Gustav Quade, laboratory medicine and technical development specialist at the Quade Laboratory in Germany. “The new Diomni Software makes it easy to work collaboratively and we can set up runs, manage past runs and documentation, and interpret fluorescent curves remotely and efficiently without the need to install special software.”
The QuantStudio 7 Pro 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) as a class II medical device.
For more information, please visit www.thermofisher.com/quantstudio7prodx.
*The QuantStudio 7 Pro Dx Real-Time PCR System is For In Vitro Diagnostic Use.
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/20220911005026/en/
Contact information
Media Contact Information:
Mauricio Minotta
Phone: 760-805-5266
Email: mauricio.minotta@thermofisher.com
Jennifer 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
ZincFive Launches Next-Generation BMS, Setting a New Standard for Nickel-Zinc Battery Management9.9.2026 15:05:00 EEST | Press release
ZincFive®, the leader in nickel-zinc (NiZn) battery-based solutions for immediate power applications, today launched the ZincFive BMS, a next-generation battery management system purpose-built for its NiZn chemistry, designed and assembled in the U.S. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909653032/en/ The ZincFive BMS ships standard with every ZincFive BC Series UPS Battery Cabinets, serving as the primary interface for data center operators, UPS OEM partners, and system integrators to monitor and manage ZincFive’s technology. Built on years of experience managing NiZn in real-world data center environments, ZincFive engineered the BMS around the unique characteristics of its NiZn chemistry, rather than adapting a platform designed for lithium-ion or lead-acid batteries. The result is a streamlined two-tier hardware architecture, consisting of the ZincFive Controller and ZincFive Tray Monitor, that delivers high
EIG Announces Final Close of Senior Infrastructure Debt Fund VI With $4.0 Billion Raised Across Its Direct Lending Platform9.9.2026 15:00:00 EEST | Press release
EIG, a leading institutional investor in the global energy and infrastructure sectors, today announced the final close of EIG Senior Infrastructure Debt Fund VI (“SIDF VI”) at $1.9 billion, nearly double the size of its predecessor fund. Together with $2.1 billion committed to single investor vehicles, this exceeds the strategy's original $3 billion target and reflects strong demand from investors seeking customized and evergreen exposure to senior infrastructure debt. Since launching in July 2024, SIDF VI has already committed approximately $1 billion across 16 investments, reflecting strong proprietary origination capabilities. SIDF VI seeks to make directly originated, senior secured debt investments across a broad range of sectors, including power generation, renewable energy, energy transition infrastructure, midstream and other critical infrastructure, with a primary focus on opportunities in the United States and Europe. The strategy draws on EIG's longstanding relationships wit
CoreTrust Expands International Presence, Extends Global Procurement Platform Across Europe9.9.2026 15:00:00 EEST | Press release
CoreTrust, a premier group purchasing organization (GPO) with more than 20 years of leveraging data-driven procurement intelligence and $7 billion in aggregated spend, today announced the expansion of CoreTrust Europe and its procurement platform to the United Kingdom and key European markets, including France, Germany, Ireland, the Netherlands, Sweden, and Switzerland. While members can enroll when headquartered in these seven markets, CoreTrust’s supplier partners deliver negotiated coverage that reaches members well beyond them. This strategic international expansion answers direct demand from CoreTrust’s private equity partners and multinational members to extend the company’s proven model into large, still-underserved European markets — the same demand-led path CoreTrust has followed for nearly two decades in the United States. CoreTrust Europe features nine trusted supplier partners across core indirect spend categories — including Dell, FedEx, and Lyreco, among others — enabling
Bracco Expands BubbleGen Cell Selection with CD3 + T Cell Isolation Kit9.9.2026 15:00:00 EEST | Press release
Bracco Imaging, a global pharmaceutical company that develops, manufactures, and markets innovative healthcare solutions, today announced the expansion of its BubbleGen™ cell selection portfolio with the launch of the BubbleGen CD3+ T Cell Selection Kit. The kit, built on Bracco's microbubble technology, can enable new cell therapy workflows, including a highly scalable and cost-effective approach to manufacturing CAR-T cell therapies. This marks the first of multiple planned expansions of the BubbleGen family of cell selection solutions following the launch of its early access program in May this year. Cell selection is a critical step in cell therapy manufacturing, but the industry standard magnetic bead-based approach adds complexity, time, and cost to workflows – the enemies of scale. BubbleGen is Bracco’s response to industry demand for non-magnetic bead-based alternatives, providing a gentle selection method that minimizes cell perturbation for more reliable downstream applicatio
FiRa Consortium Appoints Sunil Jogi as President9.9.2026 15:00:00 EEST | Press release
The FiRa Consortium® today announced the appointment of Sunil Jogi as President, marking a significant milestone in the organization’s continued growth. Through specifications and certification that build on IEEE 802.15.4, FiRa is strengthening the global ecosystem for secure, interoperable ranging and positioning solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909016899/en/ Jogi is a respected wireless and semiconductor industry leader with more than 25 years of experience. Throughout his career, he has driven innovation, built global ecosystems, and fostered industry collaboration. His appointment reflects FiRa's commitment to continued growth and stronger alignment across the ultra-wideband (UWB) and broader wireless industries. Jogi previously served on the FiRa Board of Directors and as Co-Chair of the Requirements Working Group, helping shape the organization’s strategic direction and use case requirements
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