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
Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)6.5.2026 02:00:00 EEST | Press release
Samsung Bioepis Co., Ltd. announced today that the Phase 1 study on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), has met its primary pharmacokinetics (PK) endpoints. The randomized, double-blind, three-arm, parallel group, multicenter clinical trial demonstrated pharmacokinetic bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. Initiated in January 2024, Phase 1 study is being conducted in four countries, and is expected to be completed by November 2026.2 The study assessed pharmacokinetics, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every 3 weeks, maximum 18 cycles over about 51 weeks, and blood samples were collected. The preliminary pharmacokinetic evaluation indicates t
Megaport Launches Built-In DDoS Protection Enabling On-Demand Network Resilience6.5.2026 01:00:00 EEST | Press release
Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced the launch of Megaport DDoS Protection. This new, built-in security capability for Megaport Internet allows customers to filter malicious traffic directly within the Megaport network rather than routing it through a separate or external service, for mission-critical uptime without introducing additional latency or routing complexity. As enterprises increasingly migrate to distributed cloud environments, traditional DDoS mitigation has struggled to keep pace with cloud and distributed infrastructure adoption. Standard ISP solutions often resort to dropping all traffic and taking the service offline to protect the network, while external third-party providers force a "security detour" that reroutes traffic through public infrastructure, introducing significant latency and complexity. Megaport DDoS Protection removes these challenges by integrating fabric-native protection directl
IFF Reports First Quarter 2026 Results5.5.2026 23:23:00 EEST | Press release
IFF (NYSE: IFF) reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Consolidated Summary: Management Commentary “IFF is off to a solid start in 2026, with first quarter results that reflect the customer focus and operational execution we’ve been building across the company,” said Erik Fyrwald, CEO of IFF. “We delivered volume growth in all four segments, improved profitability, and generated strong cash flow in the first quarter. As we look ahead, we are maintaining a disciplined approach to how we are planning the balance of the year as the current operating environment remains unsettled. We remained focused on advancing our commercial and innovation pipelines, driving productivity, and working with customers to offset inflation. This – when combined with our solid start to the year – derisks the balance of the year and gives us the confidence to reaffirm our full-year 2026 financial guidance ranges in an uncertain environment. At the same time, w
Logitech Announces Q4 and Full Fiscal Year 2026 Results5.5.2026 23:06:00 EEST | Press release
SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the fourth quarter and full Fiscal Year 2026. For Fiscal Year 2026: Sales were $4.84 billion, up 6 percent in US dollars and 4 percent in constant currency compared to the prior year. GAAP operating income was $775 million, up 18 percent compared to the prior year. Non-GAAP operating income was $911 million, up 18 percent compared to the prior year. GAAP earnings per share was $4.80, up 16 percent compared to the prior year. Non-GAAP EPS was $5.78, up 19 percent compared to the prior year. Cash flow from operations was $1.04 billion. The year-ending cash balance was $1.7 billion. The Company returned $768 million of cash to shareholders through its annual dividend payment and share repurchases. For Q4 Fiscal Year 2026: Sales were $1.09 billion, up 7 percent in US dollars and 3 percent in constant currency compared to Q4 of the prior yea
Sentinel Midstream Advances Texas GulfLink Deepwater Port5.5.2026 23:00:00 EEST | Press release
Sentinel Midstream LLC (Sentinel) today announced the commencement of its Texas GulfLink deepwater port (Texas GulfLink or the Project), marking a significant milestone enabled by funding received pursuant to the U.S.—Japan Trade Agreement. The project advances in coordination with the U.S. Department of Commerce and the Government of Japan and reflects the shared commitment to strengthening global energy security and expanding U.S. export infrastructure. Sentinel will lead the development of Texas GulfLink, overseeing construction, commercial operations, and long-term management of the terminal. Funding provided under the U.S.—Japan Trade Agreement, pursuant to Executive Order 14345 signed on September 4, 2025, underscores continued international confidence in U.S. energy infrastructure and supports the expansion of American crude oil exports to global markets. Upon this commencement, Texas GulfLink will immediately begin construction of its deepwater crude oil export terminal, unlock
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