CA-THERMO-FISHER
31.5.2024 08:01:28 CEST | Business Wire | Press release
Thermo Fisher Scientific Inc., the world leader in serving science, announced today that the Applied Biosystems™ CytoScan™ Dx Assay and Applied Biosystems™ Chromosomal Analysis Suite (ChAS) Dx software now comply with In Vitro Diagnostic Regulations (IVDR) 2017/746 in the European Union. These compliance updates will enable cytogenetics testing laboratories to adapt to the latest medical device safety and efficacy frameworks and conformity assessments.
“Thermo Fisher’s unparalleled commitment to driving innovation in chromosomal microarrays has led to advancement of cytogenetic testing capabilities,” said Kevin Lowitz, vice president and general manager, microarray, at Thermo Fisher Scientific. “The compliance updates to the CytoScan Dx Assay kit and ChAS Dx software provide our customers in the EU with solutions that can help them maintain high patient safety standards and meet EU IVD regulatory requirements.”
Advancements in chromosomal microarrays (CMAs) have greatly expanded the capabilities of cytogenetics testing in recent years, including the ability to yield insights into genetic risk factors and disorders that are essential to understanding reproductive health. As an in vitro diagnostic CMA test for postnatal analysis, the CytoScan Dx Assay aids in the identification of underlying genetic causes of neurological and dysmorphic disorders in children. The assay enables users to accurately detect numerous chromosomal variations at higher resolution and greater coverage than conventional methods. It has demonstrated to improve diagnostic yield by an incremental 12.5% compared to G-banded karyotyping.
ChAS Dx is a powerful, intuitive software that simplifies cytogenetic analysis, visualization, and reporting of chromosomal aberrations across the genome. ChAS Dx provides whole-genome support for CytoScan Dx Arrays with flexible parameters and data formats, as well as direct access to multiple leading external genetic databases. The advanced data analysis software is available to all CytoScan Dx customers at no additional cost.
The complete IVDR compliant CytoScan Dx Cytogenetics Suite is a sample to insight solution that includes the CytoScan Dx Array, a reagent kit, the Applied Biosystems™ GeneChip™ System 3000 Dx platform for array processing, and user-friendly ChAS Dx software.
To learn more about the complete IVDR compliant CytoScan Cytogenetics Suite, please visit www.thermofisher.com/microarrayivd.
For In Vitro Diagnostic Use.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $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/20240530659960/en/
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
Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings & Gatbits IT Infrastructure Announce Launch of GTBS Digital Ecosystem; Mainnet Set for April 202630.3.2026 20:30:00 CEST | Press release
The Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings, in collaboration with Gatbits IT Infrastructure, has officially announced the launch of the GTBS Digital Ecosystem, marking a significant step forward in the global Web3 space. The announcement follows the successful launch of the native GTBS Coin on December 25, with the ecosystem’s mainnet scheduled to go live in April 2026. GTBS represents a full-stack Web3 ecosystem integrating blockchain, artificial intelligence, decentralized finance (DeFi), entertainment, gaming, media, and cloud infrastructure into a unified platform. Built on the philosophy of “All Commitment On Time,” the ecosystem focuses on delivering reliability, scalability, and real-world utility. Designed as a comprehensive digital infrastructure, GTBS goes beyond standalone crypto platforms by offering an integrated environment for users, developers, creators, and enterprises. Its proprietary Layer-1 blockchain powers seamless interaction across se
Yubico Appoints Poupak Modirassari Enbom as Chief Marketing Officer to Accelerate Global Momentum and Drive Market Leadership30.3.2026 15:00:00 CEST | Press release
Yubico (NASDAQ STOCKHOLM: YUBICO), the creator of the most secure passkeys and a leading provider of hardware authentication security keys, today announced the appointment of Poupak Enbom as Chief Marketing Officer (CMO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330278027/en/ Enbom joins Yubico at a pivotal moment as organizations worldwide accelerate the shift to phishing-resistant authentication and modern identity security in the age of AI. “We’re excited to welcome Poupak to Yubico,” said Jerrod Chong, acting chief executive officer, Yubico. “As the threat landscape evolves with AI-driven attacks and increasing automation, organizations are rethinking how they secure digital identities of both humans and AI agents at scale. She brings a unique combination of technical depth, global leadership, and customer-first mindset that will help us continue to expand our impact and support our customers and partners around
Westinghouse Celebrates Record-breaking 80 Years of Nuclear Fuel Manufacture at Springfields30.3.2026 14:00:00 CEST | Press release
Fuel manufactured at Springfields has generated enough energy to supply the UK’s electricity demand for 26 years, avoiding the emission of nearly 3 billion tonnes of CO2 The Westinghouse Springfields facility in Lancashire, UK, has marked a significant milestone as the oldest continuous nuclear fuel manufacturing site in the world, starting from its original license on the 28th, March 1946. The site was chosen by the UK Government to develop nuclear fuel for the world’s earliest civil nuclear power stations, as well as subsequent Magnox and Advanced Gas Reactors (AGR) reactors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330135973/en/ From left to right: Sophie Lemaire; Marc Chevrel; Rory O'Neill; Craig Boothby; and Robert Gofton, CEO at Nuclear Institute Across the last eight decades, the Springfields site has supported the UK nuclear fleet, manufacturing more than eight million AGR pins, sintering and pressing over 5
HistoSonics Treats First Patients Evaluating the Edison® Histotripsy System for the Treatment of Benign Prostatic Hyperplasia (BPH)30.3.2026 14:00:00 CEST | Press release
HistoSonics, the developer of the Edison® Histotripsy System and novel histotripsy therapy platform, today announced the successful treatments of the first patients in WOLVERINE, a prospective feasibility trial evaluating the Edison® Histotripsy System for the treatment of benign prostatic hyperplasia (BPH) at Prince of Wales Hospital in Hong Kong, a teaching hospital for The Chinese University of Hong Kong. The Edison System is a novel, non-invasive, image guided platform that uses the mechanical properties of focused ultrasound, called histotripsy, to destroy unwanted tissue without the need for invasive procedures, and with potentially fewer side effects than traditional, invasive therapies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330349844/en/ HistoSonics Non-Invasive Edison Histotripsy System. Image credit: HistoSonics WOLVERINE is a prospective, multi-center, single-arm feasibility trial designed to evaluate
Biocytogen Grants Taisho Pharmaceutical a License to its RenNano® Fully Human Heavy Chain-Only Antibody Discovery Platform30.3.2026 13:00:00 CEST | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that it has entered into a platform license agreement with Taisho Pharmaceutical Co., Ltd. (“Taisho”), granting Taisho the right to access and use Biocytogen’s proprietary RenNano® fully human heavy chain-only antibody (HCAbs) discovery platform for its internal research and development programs. Under the terms of the agreement, Taisho will leverage RenNano® mice to enable the generation and screening of fully human HCAbs in vivo and to support downstream research associated with antibody discovery. Financial terms of the agreement have not been disclosed. “We are very pleased to enter into this collaboration with Taisho,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “RenNano® is a robust and powerful fully human VHH discovery platform that pro
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