CA-THERMO-FISHER
7.6.2022 14:02:37 CEST | 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/
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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20220607005144/en/
Link:
About Business Wire
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
National Bank of Greece in Cyprus Goes Live With Smartstream’s Air to Consolidate Reconciliations27.5.2026 09:55:00 CEST | Press release
Key Facts National Bank of Greece in Cyprus has consolidated four previously separate reconciliations systems – Instant, Cash, SEPA, and Nostro reconciliations – into a single platform using Smartstream’s Air Cash modules. Smartstream Air’s AI-enabled capabilities significantly reduce daily manual effort, eliminate the need to work with multiple data formats, and proactively identify data quality issues from both internal sources and bank statements. Successfully deployed in three months with no existing technology to replace; Smartstream developed a custom automated encrypted file transfer solution to meet the bank’s strict data security requirements. Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces that the National Bank of Greece (NBG) in Cyprus has successfully gone live with Air, the company’s AI-enabled reconciliation solution. The go-live marks a significant step forward in the bank’s operational efficien
Duco Launches the First Agentic Operations Platform for Financial Services27.5.2026 09:20:00 CEST | Press release
Duco, today launched the first agentic Operations platform for financial services. Built on the engine that already processes 20 billion transactions every month for more than 200 clients, including seven of the top 20 banks and ten of the top 20 asset managers, the platform brings together everything firms need to run post-trade Operations alongside autonomous agents, safely and at scale. The launch establishes a breakthrough the industry has been waiting for. A tool surface, purpose-built for agents. Duco has unbundled its platform into a new alternative agent layer that reconfigures its platform into hundreds of discrete capabilities servicing post trade. Model Context Protocol (MCP) gives capabilities covering reconciliation, data preparation, data access, audit trails, exception management, document creation and more. For the first time, agents have a verified, deterministic toolset built specifically for post-trade. Agents do not replace matching, rules or audit; they use them. P
Brenus Pharma Announces FDA Acceptance of IND Application for STC-1010 (BreAK-CRC001) in MSS Metastatic Colorectal Cancer (mCRC)27.5.2026 08:49:00 CEST | Press release
STC-1010 is a first-in-class allogeneic in vivo immunotherapy for which the FDA has authorized clinical evaluation in the U.S. under the BreAK-CRC001 study. This strategic milestone enables the company to execute a global clinical strategy following European regulatory approvals (ANSM, AFMPS), first patients dosed with preliminary results and good tolerability observed in early Phase Ia. First data are expected to be presented during ESMO annual congress 2026. Brenus Pharma, a clinical stage biotechnology company developing novel in vivo immunotherapies for solid tumors, announced that the U.S. Food and Drug Administration (FDA) has accept the company's Investigational New Drug (IND) application for its first drug candidate, STC-1010, in microsatellite stable (MSS) metastatic colorectal cancer (mCRC). STC-1010 is designed to address a critical unmet need worldwide. Approximately 95% of mCRC patients have MSS tumors, which demonstrate minimal response to standard immunotherapies. The FD
Tide Crosses 2 Million Members Worldwide - Big Step Forward in Mission to Support and Grow Small Businesses27.5.2026 08:00:00 CEST | Press release
Continuing to grow in the UK and internationally, with India seeing especially strong member growth in the last 12 months In the UK, Tide has 15% market share and has helped small businesses access over £1.75bn in credit Rapid roll out of products; from admin, accounting and tax tools; subscription options; payment solutions; government registrations; bill payments and credit Tide, the UK’s leading business management platform, today announces it has crossed 2 million members globally, with India in particular seeing strong growth. More than 1.1 million small businesses joined Tide in India since the company launched there in December 2022. This makes India Tide’s fastest-growing market by member acquisition. The UK is Tide’s home market, with 900,000 SMEs, 15% market share, and the majority of the company’s revenue. Tide’s steadily expanding its presence in Europe, with Germany and France, where the platform is gaining strong traction, thanks to millions of small businesses turning to
Alfasigma presents first data on filgotinib from the Phase 3 OLINGUITO trial in axial spondyloarthritis at EULAR 202627.5.2026 08:00:00 CEST | Press release
The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific and investor media only.In the OLINGUITO Phase 3 study in radiographic (r) and non-radiographic (nr) axial spondyloarthritis (axSpA) a significantly greater proportion of patients achieved the prespecified primary endpoint of ASAS40 with filgotinib compared with placebo at week 16.The improvements in signs and symptoms of axSpA with filgotinib, an oral, once-daily JAK1 preferential inhibitor, were observed as early as week 1 and maintained over 52 weeks of treatment.In the r-axSpA and nr-axSpA filgotinib groups, of those achieving a response in the prespecified primary endpoint of ASAS40 at week 16, 84.6% and 78.0% maintained their responses to week 52, respectively.In OLINGUITO no new safety signals were observedfor filgotinib over 52 weeks, and the safety profile was consistent with the known overall safety profile.Primary results from the Phase 3 OLINGUITO tria
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