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
Exeon Analytics expands management team for next growth phase2.9.2026 11:00:00 EEST | Press release
Exeon Analytics is expanding its management team with two new roles. Wayne Jennings takes on the newly created position of Chief Solutions Officer, and Johan Roman becomes Chief Revenue Officer. The appointments fall in the company’s anniversary year, ten years after its founding as an ETH Zurich spin-off, and create the structure for the next growth phase. Exeon Analytics delivers holistic security analytics for organizations facing growing blind spots, encrypted traffic and regulatory pressure. Wayne Jennings joined Exeon Analytics in July 2024 and initially led Support and Engineering. As Chief Solutions Officer, he is responsible for the technical customer lifecycle, from pre-sales and proof of concept through implementation to long-term technical account management, and for the technical enablement of partners. Before joining Exeon Analytics, he was a Senior Manager in Cybersecurity & Privacy at PwC Switzerland, focusing on threat intelligence and incident response. Johan Roman br
euroAtlantic Airways Expands Long-Haul Fleet With a New Airbus A330-300 Aircraft2.9.2026 10:00:00 EEST | Press release
euroAtlantic Airways (“EAA”), a Njord Partners portfolio company and a leading Portuguese aircraft wet-leasing and charter business, is pleased to announce the induction of a new Airbus A330-300 aircraft into its fleet, further strengthening its long-haul widebody capabilities and reinforcing the Company's growth trajectory in the ACMI and charter markets. The Airbus A330-300 is leased from Jackson Square Aviation (JSA). Only 15 years old, the aircraft is configured in a three-class layout of Business, Premium Economy and Economy, accommodating a total of 290 passengers, and features full lie-flat seating in Business Class along with personal in-seat entertainment monitors fitted across the entire cabin. The aircraft, which will be registered as CS-TGI after completing its normal process of approval with authorities, has already completed its delivery journey, departing Kuala Lumpur (KUL) and arriving into Beja, Portugal (BYJ) on 17 August 2026. This aircraft type is known for its effi
Interoperability and Trust Key to AI Commerce: Alipay+ and S&P Global Report2.9.2026 09:33:00 EEST | Press release
A new report by Alipay+, the unified wallet gateway of Ant International, in partnership with S&P Global, reveals a growing "commerce digitalisation gap", with people increasingly expecting seamless mobile payments and intelligent digital assistance, yet friction – from inconsistent payment acceptance to trust in AI – still define their experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901394299/en/ The study, which surveyed 6,000 consumers across nine markets in Asia, Europe and the US on their cross-border spending habits, points to a major shift underway in global commerce — one where e-wallets, AI and interoperable digital ecosystems are becoming foundational to how consumers discover, transact and engage across borders. Key findings: Travel exposes gaps in global commerce infrastructure: More than half of consumers cite uncertainty around merchant acceptance (53%) or lack of access to preferred payment metho
Kontoor Brands Unveils Helly Hansen Growth Strategy and 2030 Financial Targets2.9.2026 09:30:00 EEST | Press release
Kontoor Brands, Inc. (NYSE: KTB) today announced Helly Hansen’s long-term growth strategy and 2030 financial targets, which Kontoor Brands will present at the Helly Hansen® Investor Day later today. The plan is designed to scale Helly Hansen globally while significantly expanding its profitability through 2030. "With 150 years of technical heritage and an authentic right to win globally, Helly Hansen is a brand with tremendous long-term growth potential," said Scott Baxter, Chief Executive Officer and Chairman of the Board of Kontoor Brands. "Strong alignment between our teams has allowed us to integrate quickly and move straight to executing against the opportunity ahead. Our sustained investment in Helly Hansen will be a catalyst for its next phase of growth, and we are confident in our ability to deliver significant value for our consumers, employees and shareholders for years to come." A Focused Growth Strategy: To deliver against these targets, Helly Hansen’s growth is anchored in
Axelspace Announces Partnership with Airbus Defence and Space to Deliver Satellite Imagery to a Broader Market2.9.2026 09:30:00 EEST | Press release
Axelspace Corporation (“Axelspace”), a leading microsatellite company committed to making “Space within Your Reach,” announced today a new agreement with Airbus Defence and Space, a global leader in Earth observation including optical and radar satellite imagery, to provide mid-resolution optical images captured by Axelspace’s Earth observation microsatellites “GRUS.” Under this strategic partnership, we will develop and deliver innovative solutions that meet long-term customer needs for utilizing satellite imagery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901360086/en/ GRUS is Axelspace's series of approximately 100 kg-class optical Earth observation microsatellites. GRUS-1 is currently operated as a four-satellite constellation, delivering high-frequency, wide-area imagery. This imagery, together with value-added solutions derived through processing and analysis, supports a broad range of industries, including agr
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