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
Technology Innovation Institute Completes Asteroid-Landing Probe for Landmark Emirates Mission to the Asteroid Belt5.10.2026 10:42:00 EEST | Press release
The Technology Innovation Institute (TII) has revealed the UAE-built probe it has developed for the Emirates Mission to the Asteroid Belt (EMA). The probe will soon travel to Colorado, USA, for final integration with the MBR Explorer spacecraft ahead of its planned 2028 launch. In a historic first, TII’s probe will image two planets and seven asteroids — flying past six asteroids in the main belt before culminating in a rendezvous with and landing on the seventh, 269 Justitia. If successful, the landing will make Justitia only the seventh asteroid in history to be reached on the surface by the probe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006586478/en/ H.E. Faisal Al Bannai, Secretary General of the Advanced Technology Research Council (ATRC), and H.E. Belhoul Al Falasi, Chairman of the UAE Space Agency, sign a model of the UAE-built probe developed by the Technology Innovation Institute (TII) for the Emirates Mis
JEOL: Sales launch of HAXIS: The New Low-angle Ion Milling Scanning Electron Microscope5.10.2026 10:30:00 EEST | Press release
JEOL Ltd. (President & CEO Izumi Oi) announces the development of its new low‑angle ion‑milling scanning electron microscope, HAXIS, and will commence sales on October 5, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928207899/en/ HAXIS Low-angle Ion Milling Scanning Electron Microscope HAXIS Low-angle Ion Milling Scanning Electron Microscope Background of development As advanced semiconductor device structures continue to shrink and grow more complex, it has become difficult to contact and measure microscale circuits using nano-manipulators. In addition, contact caused by probing may affect the analysis target, necessitating new failure analysis methods. JEOL has conducted long-term research on the passive voltage contrast (PVC) detection technology and established a method for stable, highly reproducible PVC observation technology through the advancement of detectors and sample preparation techniques. HAXIS is JE
Slate Asset Management and OneIM Agree to Acquire Portfolio of Grocery-Anchored Essential Real Estate in the Greater Oslo Region Valued at Approximately €250 Million5.10.2026 09:30:00 EEST | Press release
Slate Asset Management ("Slate"), a global investor and manager focused on essential real estate and infrastructure assets, and One Investment Management (“OneIM”), a global alternative investment manager, today announced they have agreed to acquire a portfolio of eight grocery-anchored retail parks in Norway from Tellus Eiendom AS. The portfolio is located in the Greater Oslo region and is anchored by Norway's leading grocery operators and discount retailers. “We are pleased to be expanding our European Essential real estate platform with this significant acquisition,” said Brady Welch, Co-Founding Partner of Slate Asset Management. “These eight retail parks sit in dominant locations along major transport corridors around Oslo. The portfolio is anchored by Norway's strongest grocery operators and benefits from CPI-linked lease structures, designed to provide durable, inflation-protected cash flows. We look forward to applying our active management to unlock the portfolio’s full potent
Bial Showcases Parkinson’s Research at MDS 20265.10.2026 09:00:00 EEST | Press release
Bial, an innovation-driven biopharmaceutical company focused on neurosciences and rare diseases, is presenting 16 scientific posters at the International Congress of Parkinson’s Disease and Movement Disorders (MDS 2026), taking place in Seoul, Korea, from 4 to 8 October. Reflecting Bial’s commitment to listening to and learning directly from people living with Parkinson’s, two presentations cover research initiatives focused on understanding their experiences, perspectives, and priorities. The first is the Patient Endpoint Preference Project (PEPP), an ongoing multinational observational study that seeks to identify and prioritise the symptoms and outcomes that matter most to people living with Parkinson’s. The second is the TRACK-PD study, which provides insights into treatment routines and adherence behaviours, contributing to a better understanding of the challenges experienced in real-world settings. These findings may support the integration of the perspectives of people living wi
Agenus Reports 48% Estimated Three-Year Survival With BOT+BAL in Recurrent Ovarian Cancer at IGCS 20263.10.2026 17:50:00 EEST | Press release
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced three-year follow-up results from the ovarian cancer cohort of its 400+ patient Phase 1b C-800-01 trial. The study evaluated botensilimab (BOT), Agenus’ multifunctional, Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), Agenus’ anti-PD-1 antibody. The results, including three-year survival and outcomes by sensitivity to platinum-based chemotherapy and by prior treatment, were presented at the 2026 International Gynecologic Cancer Society (IGCS) Annual Global Meeting in Montréal, Canada. Among patients evaluable for efficacy, three-year overall survival was 48% (n=35), unchanged from the two-year estimate, suggesting durable clinical benefit in this population. Responses and long-term survival were observed in both platinum-sensitive and platinum-resistant or refractory disease. At the last follow-up, 25% of patients who received at least one dose of treatment (11 of 44) were alive
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