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
United States Signs Participation Contract for Expo 2030 Riyadh, Strengthening Momentum For Global Participation31.10.2026 10:38:00 EET | Press release
The United States of America has signed its Participation Contract for Expo 2030 Riyadh, marking a significant milestone in the World Expo’s preparations and further strengthening the momentum for international participation in the global event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261031669001/en/ The Participation Contract was signed by His Highness Prince Faisal bin Farhan Al Saud, Minister of Foreign Affairs of the Kingdom of Saudi Arabia, and U.S. Secretary of State Marco Rubio, during a bilateral meeting held on the sidelines of the 2026 G20 Foreign Ministers’ Meeting in Atlanta, Georgia. The signing marks an important step in the United States’ journey towards Expo 2030 Riyadh, paving the way for the development of its pavilion, programming and visitor experience. It also reinforces the growing international commitment to Expo 2030 Riyadh, as countries move from confirming their participation to actively sha
ADNEC Group Kickstarts November with Two of the World’s Largest Events in the Energy and Tourism Sectors31.10.2026 05:53:00 EET | Press release
ADNEC Group, a Modon company, begins November by hosting two of the world’s most significant international events in the same week. ADIPEC 2026, the world’s largest energy event, takes place at ADNEC Centre Abu Dhabi from 2 to 5 November. Meanwhile, World Travel Market (WTM) London, one of the global travel industry’s leading gatherings, takes place at the Group’s Excel London venue from 3 to 5 November. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030918463/en/ ADNEC Centre Abu Dhabi (Photo: AETOSWire) The two events, held simultaneously at the Group’s largest venues in the UAE and the UK, reflect ADNEC Group’s capability to deliver large-scale international events across multiple markets. ADIPEC has grown alongside the venue since it was first held at the ADNEC Centre Abu Dhabi in 2006. This year’s edition is set to be the largest in the event’s history, occupying the venue’s entire 153,000 square metres of exhibition
SES and Air Astana Introduce Multi-orbit Inflight Connectivity on A321LR Fleet30.10.2026 19:35:00 EET | Press release
SES was selected by Air Astana, the award-winning flag carrier of Kazakhstan, to introduce next-generation inflight connectivity services across its Airbus A321LR fleet. The first connected aircraft entered commercial service on 29 October 2026. Fleet-wide deployment will continue across the remaining A321LR fleet. Equipped with SES’s new electronically steered array (ESA) antenna, the aircraft delivers reliable connectivity over the SES multi-orbit network. SES will provide a fully managed inflight connectivity service across the fleet, enabling Air Astana passengers to enjoy a seamless online experience throughout their journey. “Airlines are increasingly looking for connectivity solutions that deliver a seamless passenger experience while providing the flexibility to evolve with changing customer expectations,” said Blane Boynton, Senior Vice President, Aviation at SES. “SES's multi-orbit solution will enable Air Astana to offer a consistent, high-quality online experience across it
CIRCOR to Expand Industrial Portfolio with Acquisition of Green Silence Group S.p.A.30.10.2026 18:06:00 EET | Press release
CIRCOR, a KKR portfolio company and global manufacturer of flow control products for industrial and naval markets, today announced that it has signed a definitive agreement to acquire Green Silence Group S.p.A., an Italian provider of hydraulic pumps, electric motors and advanced engineering solutions. The acquisition will bring together the complementary capabilities of Settima, Motive and Spin expanding CIRCOR’s Industrial portfolio with three-screw and ultra-low-noise hydraulic pumps, Motive electric motors, high-efficiency rare-earth-free motor technologies, power electronics and advanced engineering capabilities. Together, these technologies will broaden CIRCOR’s ability to deliver integrated solutions that improve system efficiency, reduce energy consumption and critical raw materials dependency, and address evolving customer needs across industrial and mobile applications. The combination will also provide Green Silence Group access to CIRCOR’s global commercial and operational
Quectel Sues Telit, Alleging False Statements, Cybersquatting and Unfair Competition30.10.2026 17:41:00 EET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announced that it has filed legal action in the United States District Court for the Southern District of Florida against Telit IoT Solutions Inc. The lawsuit seeks to bring an end to Telit’s campaign of false and misleading claims about Quectel and its products. Quectel alleges that, rather than competing on the strength of its products and technology, Telit engaged in a coordinated campaign to undermine Quectel’s reputation by exploiting geopolitical concerns surrounding Chinese technology companies. According to the complaint, Telit funded, promoted, and amplified false and misleading claims about Quectel’s products while positioning itself to customers as a safer “Western” alternative. The lawsuit further alleges that Telit engaged in cybersquatting involving Quectel’s U.S. domain name to advance its campaign. Quectel maintains that these alleged actions have caused substantial harm to its sales, customer
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