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
ARIS Launches Process Context for Enterprise AI, Reinforcing Position as the Essential Platform for AI Ecosystem20.10.2026 15:00:00 EEST | Press release
ARIS, the pioneer in business process management whose powerful Enterprise Model has been the foundation for enterprise operations for more than three decades, today launched Process Context for Enterprise AI – to become the critical base layer for the agentic ecosystem, giving agents and applications the business understanding they need to deliver measurable new value. While Process Context is becoming critical for successfully deploying and scaling enterprise AI, it demands far more than simply connecting AI agents to business data. It requires a comprehensive foundation that captures the relationships between processes, people, systems, risks and controls. Built on a comprehensive Digital Twin of the Organization that connects how work is designed with the execution data that sits around it, ARIS provides this critical layer of Process Context from more than 30 years of enterprise knowledge and experience, something new entrants to the space are struggling to replicate. The importan
Hologic and Inpeco Announce Co-Marketing Partnership to Advance Molecular Laboratory Automation20.10.2026 15:00:00 EEST | Press release
Hologic, Inc., a global leader in women’s health and diagnostics, and Inpeco S.A., the global leader in Total Laboratory Automation, today announced they have signed a co-marketing partnership for Inpeco’s automation solution FlexLab™ X and Hologic’s Panther® System in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261020837126/en/ Hologic and Inpeco S.A. announce a co-marketing partnership for Inpeco's automation solution FlexLab™ X and Hologic’s Panther® System in Europe. Inpeco’s recently launched FlexLab X system enables laboratories to connect multiple Panther Systems. By combining Hologic’s fully-automated molecular diagnostics platform with FlexLab X‘s open automation capabilities, laboratories can achieve high-throughput workflows with the potential to increase sample volumes1 and enhance end-to-end sample traceability2, supporting reliable test results for optimal patient outcomes.3 The Panther System will i
Debiopharm Highlights Clinical Momentum Across DDR Portfolio at ESMO 2026, Advancing WEE1-Based Therapies in Ovarian and Uterine Cancers and Glioblastoma20.10.2026 15:00:00 EEST | Press release
Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard of care to cure cancer and infectious diseases, today announced their upcoming Phase 1/Phase 2 clinical updates at the European Society for Medical Oncology (ESMO) Congress (Madrid, Spain, 23-27 October). During the event, Debiopharm will highlight clinical updates on its pipeline targeting the DNA Damage Response (DDR), featuring single-agent data on zedoresertib (Debio 0123) as well as rational combination strategies, with both temozolomide in glioblastoma and with lunresertib (Debio2513) in solid tumors. Debiopharm’s planned activities at ESMO 2026 include: Rapid Oral Presentation (Debio 0123-GBM-105 / NCT05765812): Presenting dose escalation data evaluating zedoresertib in combination with temozolomide in patients with recurrent or progressive glioblastoma. Poster Presentation (Debio 0123-102 / NCT05109975): Presenting Phase 1 expansion data evaluating s
Visa, BILL and Billtrust Launch First Live Pilot for Trusted AI Agent Payments Between Buyer and Supplier Platforms20.10.2026 15:00:00 EEST | Press release
Visa (NYSE: V), BILL (NYSE: BILL) and Billtrust today announced they have launched the first live pilot to enable trusted AI agents to initiate and complete approved buyer invoice payments end-to-end through supplier portals. Until now, many payment portals relied on human authentication requirements that limited how approved payments could be automated. Together, with leading accounts payable and receivable solutions providers BILL and Billtrust, the Visa Intelligent CommerceTM portfolio helps bridge that gap. Leveraging offerings such as Visa Trusted Agent Protocol, AI agents can now be securely authenticated to credentialed portals. As a result, buyer payments that previously relied on manual entry can be completed by trusted AI agents, while preserving supplier control and oversight. How trusted AI agents are overcoming one of payment automation’s biggest barriers The flow begins when the authorized BILL Payment Agent — registered using Visa’s Trusted Agent Protocol and Agentic Dir
FiRa Consortium Launches Core 4.1 Specifications and Enhanced Certification Program20.10.2026 15:00:00 EEST | Press release
The FiRa® Consortium today announced the release of the FiRa Core 4.1 Specifications and an updated 4.1 Certification Program to help advance ultra-wideband (UWB) interoperability within the FiRa ecosystem. Core 4.1 introduces enhancements for FiRa Untracked Navigation, expanded cryptographic security certification, and additional support for concurrent ranging and data capabilities across multi-vendor FiRa deployments. The release supports deployment requirements defined by the FiRa Frameworks and Profiles Sub-Group (FPSG), including high-density indoor positioning, hardware-level security, and concurrent data capabilities for FiRa use cases. Features of the FiRa Core 4.1 Specifications and Certification Program Enhanced Downlink Time Difference of Arrival (DL-TDoA) for FiRa Untracked Navigation — Adds coordinate-system and anchor-location encoding options, including floor identification without increasing message size, with certification coverage for these options and cross-cluster s
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