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
Venture Global Announces Closing of $2.25 Billion of Senior Secured Notes12.6.2026 00:00:00 EEST | Press release
Venture Global LNG, Inc. (“Venture Global”) announced today that its wholly-owned subsidiary, Venture Global LNG, Inc. (the “Issuer”) has closed its offering of $1.125 billion aggregate principal amount of its 6.375% senior secured notes due 2034 (the “2034 Notes”) and $1.125 billion aggregate principal amount of its 6.625% senior secured notes due 2036 (the “2036 Notes” and, together with the 2034 Notes, the “Notes”). The Issuer used the gross proceeds from the offering to redeem all of the Issuer’s outstanding 8.125% senior secured notes due 2028 (the “Existing 2028 Notes”) and used cash on hand to pay the redemption premium and related fees and expenses for the offering and the redemption. The 2034 Notes will mature on December 15, 2034, and the 2036 Notes will mature on June 15, 2036. The Notes were issued at par. The Notes will initially not be guaranteed by any of the Issuer’s subsidiaries. In the future, certain of the Issuer’s subsidiaries that incur or guarantee certain amount
Venture Global and Atlantic-SEE Announce Expansion of Long-Term LNG Sales and Purchase Agreement with Greece11.6.2026 23:30:00 EEST | Press release
Today, Venture Global, Inc. (NYSE: VG) and ATLANTIC – SEE LNG TRADE S.A. of Greece announced an expansion of their existing Sales and Purchase Agreement (SPA) for the purchase of U.S. liquefied natural gas (LNG) from Venture Global for twenty years starting in 2030. Under the deal, Atlantic-SEE is doubling their existing contract with Venture Global from a minimum of 0.5 million tonnes per annum (MTPA) to 1.0 million tonnes per annum (MTPA). Atlantic-SEE LNG is a newly formed joint venture announced in November at the 6th Partnership for Transatlantic Energy Cooperation (PTEC) conference hosted in Athens, Greece between Greek companies AKTOR Group and DEPA Commercial. The announcement of this expanded supply agreement follows Venture Global’s previously announced investment in regasification capacity at the Alexandroupolis LNG import terminal in Greece, which currently accounts for approximately 25% of the terminal’s total capacity. The Alexandroupolis LNG FSRU receiving terminal and S
Merrithew ® Expands Global Mindful Movement Leadership with Acquisition of the GYROTONIC ® Organization11.6.2026 18:30:00 EEST | Press release
Merrithew®, a global leader in mindful movement education and equipment and creator of internationally recognized programs including STOTT PILATES®, ZEN•GA®, Halo® Training and Total Barre®, today announced the acquisition of the GYROTONIC® organization, creator of the globally respected GYROTONIC® and GYROKINESIS® methods. Founded by Juliu Horvath, the GYROTONIC® and GYROKINESIS® methods are internationally recognized for their distinctive approach to movement, combining fluidity, strength, mobility, coordination, and rehabilitation through specialized equipment and movement sequences. Practiced in studios and wellness centers worldwide, the methods have cultivated a deeply loyal global community of instructors, trainers, therapists, and movement professionals. The acquisition marks a significant milestone in Merrithew International Inc.’s growth strategy and reflects Merrithew’s commitment to growing the rapidly expanding global mindful movement category. The addition of the GYROTONI
GigaDevice Expands Optical Communication Portfolio with New GD32E512 and GD32E252 Series MCUs for Optical Modules11.6.2026 17:00:00 EEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, has introduced the new GD32E512 and GD32E252 series MCUs specifically designed for optical module applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611850679/en/ Empowering Optical Interconnect Innovation, GigaDevice Unveils Dedicated MCUs for Optical Modules. As a leading supplier of MCUs for optical module applications, GigaDevice has maintained a strong focus on the optical communication market, continuously aligning its product development with evolving industry requirements and next-generation optical interconnect technologies. Leveraging years of expertise in optical module control solutions, GigaDevice has established a strong position in the market through continuous innovation and close collaboration with industry partners. To further support the advancement of high-sp
Saudi Arabia at the Center of the Global Water Industry as IDWS 2026 Reshapes the Future of Water11.6.2026 16:47:00 EEST | Press release
In an increasingly resource-constrained world, water has become critical to both economic growth and national security, driving demand for global leadership in sustainability, innovation, and water solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611388456/en/ Saudi Arabia at the Center of the Global Water Industry as IDWS 2026 Reshapes the Future of Water (Graphic: AETOSWire) The Saudi Water Authority has announced the return of the Innovation Driven Water Sustainability Conference (IDWS), taking place from 7 to 9 December 2026 at The Ritz-Carlton, Jeddah, as the Kingdom consolidates its position at the center of the global water conversation. As home to one of the world’s most advanced and rapidly evolving water management ecosystems, Saudi Arabia currently operates more than 500 water production facilities across the Kingdom with total water production capacity exceeding 16.2 million cubic meters per day. The
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