Thermo Fisher Scientific Updates Chromosomal Microarray Analysis Solutions to Comply with IVDR Regulation
31.5.2024 09:00:00 EEST | 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/
Contact information
Amanda Strickland
Thermo Fisher Scientific
Phone: +1 510-566-8921
E-mail: Amanda.strickland@ppd.com
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
Vultr and AMD Support the University of Cambridge's TESSERA AI Project to Accelerate Global Environmental Monitoring22.7.2026 16:00:00 EEST | Press release
Vultr, the world’s largest privately-held cloud infrastructure company, and AMD, a leader in high-performance and AI computing, have announced their support for the University of Cambridge's Energy & Environment Group in developing TESSERA, a groundbreaking AI foundation model designed to monitor environmental change internationally at unprecedented scale. Vultr is providing the computational infrastructure, based on AMD Instinct MI325X accelerators, necessary to generate global embeddings covering Earth's land surface from 2017 to 2025, enabling applications in agriculture, biodiversity conservation, and renewable energy infrastructure monitoring. The collaboration represents a significant advancement in applying artificial intelligence to planetary conservation challenges. TESSERA processes data from European Space Agency Sentinel satellites to create detailed embeddings - compressed AI representations - of every 10-meter square of Earth's surface. TESSERA represents the most accurat
Omilia Appoints Ryan Kam as Chief Marketing Officer to Lead Global Brand and Growth Strategy22.7.2026 15:00:00 EEST | Press release
Omilia, a global leader in Self-Learning Agentic CX, today announced the appointment of Ryan Kam as Chief Marketing Officer (CMO). Ryan will be responsible for Omilia's global brand, demand generation, and marketing strategy as the company scales its go-to-market presence across enterprise markets. In his new role, Kam will own Omilia's global marketing function, spanning brand strategy, demand generation, product marketing, analyst relations and communications. He joins at a moment of significant commercial momentum: Omilia has seen accelerating enterprise demand across all industries and is investing in a marketing engine built to match the pace of its growth. Ryan Kam brings more than 20 years of marketing leadership across some of the most recognized names in enterprise technology. Most recently, he served as CMO at Egnyte, a leader in cloud content security and governance. Prior to that, Kam held the CMO role at LogicMonitor, where he drove growth for one of the leading infrastruc
Echodyne Announces ATAK Integration for MESA® Radar Platform22.7.2026 15:00:00 EEST | Press release
Echodyne, the radar platform company, today announced the availability of an Android Team Awareness Kit (ATAK) plugin for its MESA® radar platform. The integration enables users to configure, control, and visualize data from Echodyne radars within the ATAK environment, supporting military, public safety, and security operations that rely on TAK for shared situational awareness. The plugin extends radar management and visualization capabilities to ATAK users, allowing high-fidelity radar data and system controls to be accessed through a familiar operational interface. By integrating radar data into existing TAK workflows, organizations can streamline deployment, reduce operator workload, and improve access to real-time situational awareness. TAK is a government-developed geospatial platform used across U.S. military, federal, state, and local government organizations, as well as by U.S. partner nations. According to the U.S. Army TAK Product Center, the TAK ecosystem supports 15 Departm
OneSpan Introduces DigipassONE, Bringing a Unified Platform Approach to Authentication Modernization22.7.2026 15:00:00 EEST | Press release
Organizations are under increasing pressure to modernize authentication while supporting existing infrastructure, meeting evolving regulatory requirements, deploying emerging technologies, and reducing operational complexity. For financial institutions in particular, authentication modernization must balance security, compliance, and operational efficiency while meeting the evolving expectations and preferences of their customers. Yet the journey to modern authentication is rarely a single technology transition. Organizations must continue supporting multiple authentication methods while gradually adopting new technologies, making it essential to modernize without disrupting existing environments, user experiences, or business operations. To help organizations navigate this transition, OneSpan Inc. (NASDAQ: OSPN) today announced DigipassONE™, its unified platform for authentication, transaction security, in-app protection, analytics and digital credential innovation. DigipassONE introd
StructureCraft Scales Data-Driven Design on NetApp22.7.2026 15:00:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced that StructureCraft, an award-winning global structural engineering and construction firm known for complex timber and hybrid builds, is now using NetApp to modernize and create an AI-ready data infrastructure. The new infrastructure enables the company’s employees to collaborate globally, store and manage large-scale design workloads, and take advantage of AI-driven tools on a scalable, centralized platform. StructureCraft specializes in innovative timber engineering, structural design, and sustainable building solutions for large-scale architectural projects worldwide. Its globally distributed team delivers complex projects across North America, Europe, and Asia, guided by a core purpose to engineer and build beautiful, efficient structures. The StructureCraft team regularly takes on complex projects such as designing and constructing of the Barbados National Performing Arts Pavilion, a ground-breaki
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