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
Azafaros Announces Publication of Phase 2 RAINBOW Study Data for Nizubaglustat in Molecular Genetics and Metabolism Journal5.6.2026 08:00:00 EEST | Press release
Azafaros, a private company building a portfolio to become a leader in lysosomal storage disorders (LSDs), focused on addressing neurological symptoms, today announced the publication of clinical data from its Phase 2 (RAINBOW) study in the peer reviewed journal, Molecular Genetics & Metabolism. The published manuscript reports efficacy, safety, pharmacokinetic and pharmacodynamic data which evaluated nizubaglustat in patients with genetically confirmed GM2 gangliosidosis and NPC. As previously stated in the topline results announcement in July 2024, the RAINBOW study met its primary objective of demonstrating that nizubaglustat was safe and well tolerated. The study also showed encouraging signs of clinical efficacy, reducing disease progression and seizure burden in patients treated with nizubaglustat. “The publication of the RAINBOW data in a peer-reviewed journal represents an important milestone for Azafaros and for the broader lysosomal disease community,” said Stefano Portolano,
K-Startup Grand Challenge 2026: Korea's Full-Cycle Launchpad for Global Startups5.6.2026 04:00:00 EEST | Press release
South Korea’s Ministry of SMEs and Startups (MSS) has opened applications for the K-Startup Grand Challenge (KSGC), the country’s premier government-backed acceleration program for international startups targeting Korea and Asia. Since 2016, KSGC has attracted 21,537 applicants from more than 100 countries, among the world's most recognized inbound programs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604794426/en/ South Korea’s Ministry of SMEs and Startups (MSS) has opened applications for K-Startup Grand Challenge 2026, a government-backed global startup acceleration program providing end-to-end support for international startups (Image: KSGC) A Full-Cycle Acceleration Journey Unlike conventional programs that focus on a single moment of market entry, KSGC 2026 guides startups from market entry to scale up in Korea - offered in a hybrid format - online or in person - with Demo Day held in Korea. The program runs Jul
Empire State Building Observation Deck Celebrates Soccer with World’s Most Iconic Soccer Jersey Exhibit, Custom ESB Jerseys, Player Visits, Lightings, and More5.6.2026 00:46:00 EEST | Press release
The Empire State Building Observation Deck (ESB) – the #1 Attraction in the United States – today announced further 2026 programming for soccer fans in New York City with the world’s most iconic jersey collection from the Classic Football Shirts (CFS) vault, a limited-edition ESB x CFS jersey, official merch giveaways, and special lightings. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604370013/en/ Empire State Building Observation Deck Celebrates Soccer with World’s Most Iconic Soccer Jersey Exhibit, Custom ESB Jerseys, Player Visits, Lightings, and More “As the world descends upon New York City for this anticipated global soccer event, fans can visit the Empire State Building Observation Deck for Manhattan’s best skyline views and a one-of-a-kind soccer exhibit,” said Dan Rogoski, observatory general manager. “International and American soccer fans can extend the celebration off the pitch at the #1 Attraction in the
Vycellix to Provide Universal Cell Cancer Therapy Progress Reports at Upcoming Investor & Partnering Meetings4.6.2026 21:15:00 EEST | Press release
Vycellix, Inc., a biotechnology company developing next-generation allogeneic natural killer (NK) cell-based therapies designed to overcome the risk of immune rejection and redefine functional persistence with durability, today announced the Company will attend a series of upcoming investor and partnering meetings to share progress reports on the Company’s universal cell therapy platforms and product candidates targeting multiple myeloma, acute myeloid leukemia and urothelial cancers. Vycellix is attending: June 8-9: U.S. Department of Commerce Certified Trade Mission to Norway in Oslo June 11-14: European Hematology Association (EHA) 2026 Congress in Stockholm June 22-25: BIO International Convention in San Diego (Florida Pavilion, Booth# 1319) To request a meeting with Vycellix at any of these events, please contact Doug Calder at dcalder@vycellix.com. Vycellix recently announced the successful completion of pre-clinical development for its universal cell engineering platform (VY-UC)
Sodali & Co Appoints Fabio Bianconi as Head of Italy4.6.2026 20:15:00 EEST | Press release
Sodali & Co, the leading global capital markets-centric stakeholder advisory firm, today announced the appointment of Fabio Bianconi as Head of Italy, effective immediately. Fabio succeeds Andrea Di Segni, who will transition into a new role as Senior Relationship Advisor, where he will continue to support key client relationships and strategic initiatives across the firm. Fabio brings deep experience, strong client relationships, and a track record advising on complex mandates in the Italian market. He will lead Sodali’s continued growth and development in Italy, building on the firm’s established position in the region. Aneliya Crawford, Chief Partnerships Officer & Global Head of Shareholder Advisory of Sodali & Co, said: “Andrea has played a central role in the evolution of Sodali over more than two decades, helping establish the firm as a trusted global advisor in corporate governance and shareholder engagement. He built our Italian business into a leader in the market, as reflect
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