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
LTM Launches BlueVerse™ RightLogic to Address Cyber Risk in AI Era6.7.2026 12:12:00 EEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, has launched BlueVerse™ RightLogic, a cybersecurity assessment and risk assurance framework designed to help enterprises identify, assess and remediate cyber exposure as they accelerate AI adoption. AI is now capable of autonomously identifying and exploiting vulnerabilities, while exposure across infrastructure, applications and supply chains continue to expand. This has elevated cyber risk from a technology concern to a board-level priority, with enterprises struggling to maintain visibility and respond at the speed of emerging threats. BlueVerse RightLogic addresses this gap by providing a unified, business-aligned view of enterprise exposure and enabling a shift from fragmented, point-in-time assessments to continuous, evidence-led risk management. The framework combines an end-to-end AI and cyber exposure assessment engine with a structured execution model that spans from assessment to remediation. At the cor
Media Release: Financial Worries Rise and Match Health Concerns as Cost-of-Living Pressures Mount in 20266.7.2026 11:00:00 EEST | Press release
Households around the world are feeling the strain of the rising cost of living, with financial pressure increasingly shaping everyday choices and long-term confidence. Finances and health are now tied as the top global worries, at 48% each, followed by concerns about the future at 35%, according to consumer surveys in 10 countries published in “The Allianz 3am Report 2026.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260703907741/en/ Allianz / IPSOS “What Worries the World” Study, April – June 2026. Financial worries, which include concerns about “rising cost of living” (71%) and “insufficient income” (51%), increased in seven out of eight countries surveyed year over year, moving up in the ranking of top three worries in Brazil, France, Germany, and the U.K., while remaining stable in Italy. The strongest increases are observed in Australia and Indonesia, where financial concerns have remained the leading worry, as well
HAZAMA ANDO Becomes an Official Partner in Helical Fusion’s Commercial Fusion Initiative and Signs MoU Toward Construction of the Fusion Pilot Plant6.7.2026 09:40:00 EEST | Press release
Helical Fusion Co., Ltd. (“Helical Fusion”), a Japan-based fusion energy startup developing fusion power plants, and HAZAMA ANDO CORPORATION (“HAZAMA ANDO”), a long-established Japanese general contractor, today announced that HAZAMA ANDO has become an Official Partner in the Helix Program, Helical Fusion’s commercial fusion initiative. The two companies have also signed a memorandum of understanding (“MoU”) to collaborate toward the construction of Helix KANATA, Helical Fusion’s Fusion Pilot Plant targeted for the 2030s. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706176052/en/ (L-R) Kazuhiko Kuniya (Representative Director and President, HAZAMA ANDO CORPORATION) and Takaya Taguchi (Co-Founder and CEO, Helical Fusion Co., Ltd.) at a press conference in Tokyo on July 6, 2026. Fusion energy has the potential to shift the foundation of energy from natural resources to advanced technology by reproducing, on Earth, the sam
Sofinnova Partners Announces Myricx Bio Agrees to Be Acquired by Novartis6.7.2026 08:15:00 EEST | Press release
Sofinnova Partners, a leading European life sciences venture capital firm, today announced that its portfolio company Myricx Bio (“Myricx”) has reached agreement to be acquired by Novartis, for up to $1.5 billion including $1.1 billion cash upfront plus potential milestone payments. This marks Sofinnova Partners' seventh exit in three years. Myricx Bio is a UK-headquartered transatlantic biotech company focused on the discovery and development of a novel class of payloads for antibody-drug conjugates. The company's platform is built around next-generation N-myristoyltransferase inhibitor (NMTi) payloads, a differentiated mechanism of action designed to address the narrow therapeutic windows and tolerability challenges that have limited earlier generations of ADCs, such as TOPO-1 and tubulin inhibitor payload classes. Myricx Bio's two lead ADC assets, directed towards the established targets B7-H3 and HER2, are designed to bring this differentiated approach to patients across a broad ra
Global New Material International Wins Technology Innovation Best Practice Award at Sino-European ESG Conference6.7.2026 06:59:00 EEST | Press release
Global New Material International Holdings Ltd. has received the Technology Innovation Best Practice Award at the Third Sino-European Corporate ESG Best Practice Conference recently in Mainz, Germany, in recognition of its efforts to advance sustainable development through material innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260705533555/en/ Thorsten Giehler (L), Director of the Economic, Social Development and Employment Division of The German Society for International Cooperation (GIZ), delivered the award to Zhou Fangchao, Executive Director and Vice President of Global New Material International. The annual conference, initiated by the Chinese Consulate General in Frankfurt and jointly organized with Chinese and European partners, recognizes corporate best practices in environmental, social and governance (ESG) performance. This year's event brought together government officials, business leaders and exper
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