Thermo Fisher Scientific Updates Applied Biosystems QuantStudio 5 Dx Real-Time PCR System to Comply with IVDR Regulations
7.6.2022 15:00:00 EEST | Business Wire | Press release
To help molecular diagnostic manufacturers and clinical testing laboratories adapt to higher-standard In Vitro Diagnostic Requirements (IVDR) now in effect in the European Union, Thermo Fisher Scientific is offering an IVDR version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System globally. The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220607005144/en/
The IVDR-compliant QuantStudio 5 Dx System simplifies molecular diagnostic workflows for infectious disease and oncology. (Photo: Business Wire)
Molecular diagnostic kit manufacturers and clinical testing labs that develop their own assays need open qPCR platforms that meet IVDR requirements. The IVDR-compliant QuantStudio 5 Dx System will enable molecular diagnostic manufacturers to develop new IVDR-compliant tests under the new regulations. The system will also help clinical labs running diagnostic tests switch to IVDR qPCR testing.
“Molecular diagnostic manufacturers and laboratories that lack appropriately validated and CE-labelled instruments and tests may face delays under the new IVDR regulations,” said Marty Murawski, vice president, regulatory and quality assurance, at Thermo Fisher Scientific. “We are committed to helping our customers maintain high patient safety standards, meet new requirements, and obtain proper accreditation to remain competitive in today’s market. By making the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System IVDR-compliant, we can now provide a high-performance, reliable qPCR system to support new testing workflows.”
Among the system’s updates, the multi-mode software is now IVDR compliant, providing dual functionality for running diagnostic tests and developing new assays in today’s regulatory environment. The qPCR system comes with an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes. In addition, a security, auditing, e-signature module provides secure operation.
The updated QuantStudio 5 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).
For more information, please visit www.thermofisher.com/quantstudio5dx.
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/20220607005144/en/
Contact information
Media:
Mauricio Minotta
Phone: 760-805-5266
Email: mauricio.minotta@thermofisher.com
Jen 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
Bregal Milestone Backs Nethive With Majority Growth Investment and JoyComm Acquisition22.10.2026 11:00:00 EEST | Press release
Bregal Milestone, a leading European software growth private equity firm, today announced a majority growth investment in Nethive S.p.A. (“Nethive” or the “Company”), a leading Italian cybersecurity services and software provider. Alongside its investment in Nethive, Bregal Milestone has also backed Nethive’s acquisition of IT security specialist Joy Comm S.r.l. (“JoyComm”). Founded in 2014 by Alessandro Bellato and Diego Rocco, Nethive has become a trusted cybersecurity partner to blue-chip enterprises, SMEs, and public-sector organizations across Italy. Its platform spans managed security services, professional services and technology resale, helping organizations protect critical infrastructure and networks, strengthen cyber resilience and reduce operational complexity. Nethive combines deep technical expertise with 24/7 monitoring, threat detection and response, risk and vulnerability management, infrastructure protection and specialist consultancy. The Company serves more than 250
EOS and VOP CZ Sign Memorandum of Understanding to Explore Cooperation on Czech Programmes22.10.2026 10:00:00 EEST | Press release
EOS Defence Systems (EOS) and VOP CZ have signed a Memorandum of Understanding (MoU) at Future Forces Forum in Prague to explore cooperation on wheeled armoured vehicle programmes for the Czech Army and other future defence projects in the Czech Republic and Europe where VOP CZ is involved. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021408045/en/ EOS and VOP CZ sign a Memorandum of Understanding at Future Forces Forum in Prague. Left to right: Martin van de Voorde, Sales Director Europe, EOS; Vlastimil Navrátil, Managing Director, VOP CZ; Pavla Ungrová, Sales Director, VOP CZ; Rear Admiral Richard Caton, Australia’s Military Representative to NATO and the EU; Group Captain Michael Schleeman, Australia’s Defence Attaché; and Matej Pupák, Program Lead, VOP CZ. The agreement brings together EOS' expertise in advanced remote weapon systems (RWS) with VOP CZ's established capabilities in military vehicle integration, produ
Ferrer and Prilenia Announce Authorization for EU Initiation of Confirmatory PRECISE-HD Study of Pridopidine in Huntington's Disease22.10.2026 10:00:00 EEST | Press release
Ferreri and Prilenia Therapeutics B.V.today announced that the confirmatory Phase 3 PRECISE-HD study of investigational pridopidine in Huntington's disease (HD) has received authorization to begin in participating EU Member States (EU CT number: 2026-526093-16-00, NCT07609108). Recruitment in the EU is expected to commence this month, joining currently recruiting sites in the US and UK, with Canada to follow. Designed to evaluate the efficacy and safety of pridopidine (administered as an oral capsule twice a day), and to generate data for regulatory evaluation, the global, approximately 400-participant, randomized, double-blind, placebo-controlled PRECISE-HD study will assess the clinical effect of the investigational treatment on disease progression, functional capacity, motor function, cognition, speech and quality of life. “The initiation of PRECISE-HD in Europe marks a milestone for the Huntington’s disease research community. This confirmatory Phase 3 study has been designed to bu
IQM Quantum Computers Announces Conference Call to Report Third Quarter 2026 Financial Results on November 5, 202622.10.2026 09:00:00 EEST | Press release
As published previously, IQM Quantum Computers Plc (Nasdaq: IQMX) ("IQM" or the "Company"), a global leader in superconducting quantum computers, will report financial results for the third quarter 2026 on Thursday, November 5, 2026. CEO Dr. Jan Goetz and CFO Jan Kuerschner will host a conference call at 3:00 PM EET / 2:00 PM CET / 8:00 AM EST on the same day followed by a Q&A session with analysts. Conference Call and Webcast A live audio webcast of the conference call will be available to the public through the link below and can be accessed in the News & Events section of IQM's Investor Relations website at https://investors.iqm.tech/. A replay of the call will be available at the same location for one year following the call. Participation in the Q&A during the conference call will require registration using the link below. Date: Thursday, November 5, 2026 Time: 3:00 PM EET / 2:00 PM CET / 8:00 AM EST Webcast Link: https://edge.media-server.com/mmc/p/syqjnhp6To ask questions on the
Galderma Delivers Net Sales of 4.765 B USD in the First Nine Months, Up 25.1% at Constant Currency Year-on-Year, and Raises Full-Year Net Sales Guidance22.10.2026 08:00:00 EEST | Press release
Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced its sales performance for the first nine months of 2026. Record net sales of 4.765 billion USD for thefirst nine months of 2026, representing 25.1% year-on-year growth at constant currency1, predominantly driven by volume and complemented by favorable mix. Broad-based double-digit growth across geographies and product categories, reflecting strong execution of Galderma’s proven integrated dermatology strategy, with stand-out performance in Therapeutic Dermatology, across both Nemluvio and the mature portfolio, as well as in Dermatological Skincare and Neuromodulators. Continued market outperformance across all three product categories, with net sales growth year-on-year at constant currency of 13.2% in Injectable Aesthetics, 16.2% in Dermatological Skincare, and 64.4% in Therapeutic Dermatology (with Nemluvio net sales of 735 million USD). Strengthening Galderma’s dermatology platform, with the pre
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