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
Ant International Unveils Global Development Centre in Malaysia, Expanding Commitment to AI, Talent, Trust and Digital Innovation1.7.2026 12:06:00 EEST | Press release
Ant International today officially opened its Global Development Centre (GDC) in Kuala Lumpur, deepening its long-term commitment to Malaysia and Southeast Asia, and strengthening the country's role as a strategic hub for global innovation, digital talent, and next-generation financial technology. The unveiling ceremony was officiated by the Prime Minister of Malaysia, YAB Dato' Seri Anwar Ibrahim. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701982923/en/ L to R: Datuk Fabian Bigar, Secretary General to Ministry of Digital, YB Senator Dato' Seri DiRaja Dr. Zambry bin Abd Kadir, Minister of Higher Education, YAB Dato' Seri Anwar Bin Ibrahim, Prime Minister of Malaysia, Cyril Han, CEO of Ant Group, Peng Yang, CEO of Ant International Ant International’s GDC is located at The Exchange 106, within TRX, Malaysia’s dedicated international financial centre. Cyril Han, CEO of Ant Group said, "With a visionary leadership and a
Haleon to Accelerate AI-powered Transformation With New Five-year Microsoft Collaboration1.7.2026 12:00:00 EEST | Press release
Haleon, a consumer health company solely focused on better everyday health, today announces a new five-year collaboration with Microsoft to scale digital, data and AI capabilities across the business and accelerate delivery of its global Win as One strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260630342896/en/ The new agreement builds on Haleon’s existing use of Microsoft 365 Copilot and further supports the wider adoption of AI-powered tools across the business, helping teams automate routine tasks, collaborate more effectively and focus on higher-value work. Importantly, it will also further strengthen Haleon’s digital and AI-enabled infrastructure through further adoption of Microsoft’s agentic AI, security and identity capabilities, helping the company to scale AI securely and responsibly. Haleon and Microsoft will co-create high-impact AI use cases which deliver value across multiple critical functions, from
Galderma Provides Progress Update Regarding RelabotulinumtoxinA Regulatory Submission in the United States1.7.2026 08:00:00 EEST | Press release
Galderma (SIX: GALD) today provided progress updates regarding the regulatory review of its pending Biologics License Application (“BLA”) for RelabotulinumtoxinA with the U.S. Food and Drug Administration (“FDA”). The Company has received a Complete Response Letter (CRL) from the FDA with comments related to observations during manufacturing site inspection and analytical method optimization. As part of its review, the FDA conducted a Pre-License Inspection (PLI) of Galderma’s manufacturing site. All other aspects of the BLA, including safety- and efficacy-related parts, did not solicit deficiencies to be addressed. The FDA made observations during the PLI for which Galderma is putting in place corrective and preventive actions. Galderma will also be seeking further guidance through continued open dialogue with the FDA toward resolution of the relevant observations. Galderma plans to rapidly respond to the CRL and advancing RelabotulinumtoxinA in the U.S. remains a top priority. The ob
EVE Energy Showcases All-Scenario Energy Storage Solutions at The Smarter E Europe 20261.7.2026 04:45:00 EEST | Press release
EVE Energy unveiled its Mr. Big Family series, a 6.9+ MWh energy storage system, and all-scenario energy storage solutions at Intersolar Europe in Munich. Drawing on traceable large-cell technology, proven large-scale energy storage project delivery experience, and global delivery capabilities, the company is addressing Europe's diverse energy storage requirements across utility-scale, commercial & industrial (C&I ), and data center segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260630889717/en/ EVE Energy showcases its Mr. Giant 3.0 6.9+ MWh energy storage system at The Smarter E Europe 2026 in Munich, Germany Advancing Large-Cell Technology with Global Project Validation As one of the first companies to focus on large-capacity energy storage cells, EVE Energy has iteratively upgraded its cell platform from 560 Ah and 628 Ah to 702 Ah, adhering to a stacking process route throughout. At the exhibition, the Mr. Gia
Bending Spoons S.p.A. announces pricing of initial public offering1.7.2026 02:56:00 EEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the pricing of its initial public offering (“IPO”) at $29.00 per share. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 shares are being offered by Bending Spoons and 23,572,375 shares are being offered by certain selling shareholders (the “Selling Shareholders”). Bending Spoons will not receive any proceeds from any sale of shares by the Selling Shareholders. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “BSP” on July 1, 2026. The offering is expected to close on July 2, 2026, subject to customary closing conditions. In addition, Bending Spoons and the Selling Shareholders granted the underwriters an option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and up to an additional 3,451,626 ordinary shares from the Selling Shareholders at the initial public offering price, less underwriting
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