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
3D Systems Achieves Full-Scope EU MDR Certification, Accelerating European Launch of NextDent® Jetted Denture Solution Targeted for Summer 202625.3.2026 18:20:00 EET | Press release
3D Systems (NYSE: DDD) today announced it has received full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745. The certification was attained on Monday, March 16, 2026. This milestone confirms that the Company’s quality system, technical documentation, and clinical evidence meet the most rigorous regulatory requirements in the medical device sector. With the MDR certificate in hand, 3D Systems will now introduce MDR-compliant product versions through a carefully coordinated, phased rollout across its dental product families and European markets. This approach ensures a smooth transition while maintaining uninterrupted product availability for customers and healthcare providers. The EU MDR certification immediately enables the introduction of innovative new materials and is a pivotal step for one of 3D Systems’ largest potential new product launches: the NextDent® Jetted Denture Solution. This solution forms the cornerstone of the Company’s ‘replac
Visa to Bring Privacy-Preserving Payments to Canton Network25.3.2026 18:00:00 EET | Press release
Visa (NYSE:V), a global leader in digital payments, today announced it will join the Canton Network as the first major global payments company to serve as a Super Validator, to help extend privacy‑preserving blockchain infrastructure to banks and financial institutions around the world. Visa will be one of 40 Super Validators on Canton. That move goes straight to a core challenge for financial institutions: the same transparency that gives blockchains their appeal can clash with privacy expectations financial institutions operate under. Canton Network, a blockchain built for regulated finance, has privacy built in from the beginning, so organizations can use shared infrastructure without exposing sensitive information. As a Super Validator, Visa will help clients who choose to run and secure operations on the Canton Network, applying the same trusted and reliable standards it uses to operate critical payment systems today. Institutions can experiment with and scale stablecoin payments,
Andersen Consulting Adds Collaborating Firm Stratis Consulting in Ireland25.3.2026 15:30:00 EET | Press release
Andersen Consulting enters into a Collaboration Agreement with Stratis Consulting, a Dublin-based firm specializing in strategic employment relations, people strategy, and workplace policy. Founded in 2017, Stratis Consulting is an advisory firm recognized for its deep expertise in employment relations and leadership strategy. The firm works closely with senior executives, boards, and HR leaders as a trusted advisor to design practical, people-centered solutions that improve engagement, strengthen leadership effectiveness, and align workforce strategy with long-term business objectives. Stratis Consulting supports organizations navigating M&A activities and major changes in the company to ensure effective practice and implementation of workforce strategies. “At Stratis, we believe that people strategy enabled by successful employment relations is business strategy,” said Brendan McGinty, managing partner of Stratis Consulting. “Our goal is to help organizations recognize the value of s
ECU Worldwide Unveils XLERATE 2.0 Expansion to Bypass Asia–Europe Supply Chain Disruptions25.3.2026 15:30:00 EET | Press release
ECU Worldwide, Allcargo Globals’ wholly-owned global subsidiary, has announced a strategic expansion of its transformative logistics solution, XLERATE 2.0, to provide a high-speed and resilient alternative to Asia-to-Europe trade lanes facing transit disruptions. Under this alternative routing, cargo is transported across the Pacific to the US West Coast, using Los Angeles (LAX) as a temporary hub. The solution leverages XLERATE 2.0’s premium, time-definite ocean services, ensuring greater transit agility and continuity. XLERATE 2.0 offers two distinct shipping solutions from China and Vietnam, providing shippers with flexibility as traditional trade arteries remain impacted by shifts in global logistics. These changes have led to reduced overall capacity and the disruption of standard sea–air services via conventional transit points. Commenting on the rollout, Simon Bajada, Regional CEO, Europe, ECU Worldwide, said “With the expansion of XLERATE 2.0, we are offering our customers a de
Incyte Announces Executive Leadership Appointments25.3.2026 15:00:00 EET | Press release
Incyte (NASDAQ:INCY) today announced appointments among its executive leadership team to support the Company’s strategic focus and long-term growth plans. Pablo J. Cagnoni, M.D., has been appointed President, Incyte and Global Head of Research and Development. In this role, Dr. Cagnoni will retain responsibility for Research and Development, while also supporting enterprise-wide strategic planning and operational execution. Under Dr. Cagnoni’s scientific leadership, Incyte’s R&D progress has been notable, including advancing our mutCALR antibody, povorcitinib, CDK2, KRASG12D and TGFßR2xPD1 programs. Dr. Cagnoni has also continued to strengthen the way Incyte conducts R&D, introducing a new structure, processes and new technologies to improve productivity and keep Incyte competitive. Steven Stein, M.D., has been appointed Executive Vice President, Chief Medical Officer and Head of Late-stage Development. In this role, Dr. Stein will continue to oversee Incyte’s extensive and growing lat
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