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
TOYO Corporation Opens Its Quantum Computers to Japan's Ecosystem15.9.2026 11:32:00 EEST | Press release
IQM Quantum Computers, a global leader in superconducting quantum computers, today announced that TOYO Corporation has purchased a second full-stack quantum computer, IQM Spark. This expands TOYO's quantum footprint and reinforces IQM's commitment to driving quantum acceleration in Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260915747723/en/ TOYO Corporation opens its quantum computers to Japan's ecosystem The Spark system will be installed at TOYO's R&D center in Kiba, Tokyo, and will be operational in early 2027, enabling hands-on learning from fundamental quantum computing education to algorithm validation and verification. This announcement follows TOYO's earlier acquisition of an IQM Radiance 20-qubit quantum computer, planned for installation at the end of 2026 at the Global Research and Development Center for Business by Quantum-AI technology (G-QuAT), a research facility operated by the National Institute o
Smartstream Further Enables Collateral Teams with Instant Answers and Controlled Automation through New MCP Servers15.9.2026 11:00:00 EEST | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces two new Model Context Protocol (MCP) servers for Smart Collateral, enabling dynamic, agentic collateral operations. Firms can connect an MCP-compatible AI assistant directly to their collateral management platform and interact with it conversationally, giving teams instant answers and controlled workflow automation while retaining full governance and oversight. Collateral operations have grown steadily more complex. As margin requirements rise and regulatory expectations continue to evolve, financial institutions are under pressure to lower operational risk and raise efficiency across the collateral lifecycle. Yet when markets move quickly, teams must still assemble a picture from several systems before they can act on it, while manual steps that would benefit from automation wait on scarce development resource. AI adoption is expanding across these organisations,
More Than Half of Global Businesses Want Greater Control Over Their Data in Latest Digital Sovereignty Push, According to Expereo15.9.2026 11:00:00 EEST | Press release
Businesses around the world are seeking greater control over their data as growing concerns around AI, security and compliance push digital sovereignty higher up the boardroom agenda, according to the latest IDC InfoBrief commissioned by Expereo*. More than half (53%) of enterprises say they want greater control over sensitive and strategic data, while 33% of global organizations now view digital sovereignty as a top or high priority. The research also found that 30% rank it among the leading drivers of technology investment, highlighting how governance, risk and compliance considerations are becoming increasingly important as organisations scale AI and cloud initiatives. The findings suggest organizations are looking beyond traditional approaches to data governance as they seek to better manage risk, regulatory obligations and operational resilience. Security and privacy concerns remain a significant barrier to AI adoption, cited by 58% of enterprises, while 54% of technology leaders
SES and Elveo Mobile Deepen Collaboration to Advance Direct-to-Device Services in Europe15.9.2026 10:30:00 EEST | Press release
SES, a global leader in space solutions, and Elveo Mobile, the company that delivers mobile connectivity and elevated intelligence for a planet on the move, today announced the expansion of their collaboration to accelerate delivery of direct-to-device (D2D) services in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260915183604/en/ SES and Elveo Mobile Deepen Collaboration to Advance Direct-to-Device Services in Europe SES will leverage Elveo’s patented, proven and cost-effective D2D technology to enable seamless mobile roaming capabilities for European consumers, businesses, governments, institutional, and defense users. To further this vision, SES and Elveo Mobile will collaborate to establish manufacturing capabilities and a robust supply chain in Europe for the productions of the Low-Earth Orbit (LEO) D2D satellites, using Elveo’s patented D2D satellite bus, payload and software technology stack. These LEO D2D s
Wolters Kluwer expands Libra legal AI workspace with authoritative expert content from Kluwer Law International15.9.2026 10:01:00 EEST | Press release
Wolters KluwerLegal & Regulatory today announced the integration of Kluwer Law International content into Libra by Wolters Kluwer, its all-in-one legal AI workspace. Customers in 11 European countries can now access content from Kluwer Arbitration, Kluwer Competition Law and Kluwer IP Law directly within Libra, further expanding the platform's portfolio of trusted legal content and expert insight. The addition of Kluwer Law International content builds on Libra's existing legal intelligence capabilities and gives legal professionals access to specialist international expertise across arbitration, competition law and intellectual property law without leaving their workflow. Content can be used alongside the broader Wolters Kluwer legal resources already available within Libra, helping users conduct research, validate arguments and draft documents with greater efficiency and confidence. “By adding Kluwer Arbitration, Kluwer Competition Law and Kluwer IP Law in Libra, we are expanding 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