Thermo Fisher Scientific Updates Chromosomal Microarray Analysis Solutions to Comply with IVDR Regulation
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
Nominations open for The MIDORI Prize for Biodiversity 2026 by AEON Environmental Foundation and the Secretariat of the Convention on Biological Diversity16.1.2026 10:00:00 EET | Press release
The call for nominations for The MIDORI Prize for Biodiversity 2026 is open from 2 February to 31 March 2026. Nominations are invited from members of the public through the AEON Environmental Foundation website at https://www.aeonkankyozaidan.or.jp/en/prize/. The Award Ceremony and Award Winners Forum of the 2026 edition of the Prize will be held on 27 August in Tokyo, Japan. These events will contribute to the global mobilization around COP 17 of the Convention on Biological Diversity (CBD), which will take place in Yerevan (Armenia) under the theme of “Taking action for Nature”. Co-organized by the AEON Environmental Foundation and the Secretariat of the CBD, the Prize is awarded to individuals who make outstanding contributions to global biodiversity-related objectives, including the conservation and sustainable use of biodiversity, and other environmental challenges such as climate change. To date, 21 individuals from 20 countries have received the prize. Established by the AEON En
Tigo Energy and Weco Certify MLPE-Inverter Compatibility to Simplify PV System Design16.1.2026 07:00:00 EET | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced the Company has signed a certificate of compatibility with Weco S.r.l., documenting the compatibility between Tigo Flex MLPE products and hybrid solar inverters from Weco. The certification covers certain single-phase and three-phase Weco products and members of the Tigo TS4-A and TS4-X product families, when properly designed and installed. Together, these products are designed to deliver high-quality, enhanced value through a system that generates and manages solar energy more efficiently and delivers the features residential energy customers demand. “The compatibility between our inverter solutions and Tigo optimizers represents a significant step forward for the entire industry, and confirms our commitment to simplifying the work of solar professionals,” said Federico Cusumano, R&D manager at Weco S.r.l. “Thanks to this certification, design
Binarly to Unveil “Broken Trust” Research: Firmware Bypass Chains, BMC Persistence, and EDR Evasion16.1.2026 00:04:00 EET | Press release
Binarly, the industry leader in software and firmware supply-chain security, today announced an upcoming DistrictCon presentation “Broken Trust: Firmware Bypass Chains, BMC Persistence, and EDR Evasion.” The session will detail how firmware-level attack chains observed in shipped enterprise devices can effectively undermine modern endpoint defenses, enabling stealthy compromise and long-lived persistence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115834965/en/ Binarly Unveils Broken Trust Research: Firmware Bypass, BMC Persistence In this presentation, the Binarly REsearch team will dismantle the assumption of hardware trust by presenting multiple real-world firmware bypass chains. Alex Matrosov and Fabio Pagani will provide a deep dive into the specific vulnerability classes and exploitation primitives that make these attacks reliable in practice. The team will also deliver a live demonstration compromising a fully
World Economic Forum and Salesforce Empower Global Leaders With First-of-its-Kind Agentic Assistant for the 2026 Annual Meeting in Davos15.1.2026 20:06:00 EET | Press release
Salesforce (NYSE: CRM), the world’s #1 CRM, today announced the activation of the World Economic Forum’s institutional knowledge powered by Agentforce 360 to support over 3,000 of the world’s most influential leaders at the 2026 World Economic Forum Annual Meeting. The Forum has launched a new proactive, high-precision concierge app, “EVA,” built on the Agentforce 360 Platform, Salesforce’s agentic platform. EVA will empower attendees to move beyond traditional information access, with an AI agent that doesn’t just answer questions, but can reason, prioritize, and act on a leader’s behalf for the 2026 Annual Meeting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115571119/en/ Scheduled for January 19–23 in Davos, Switzerland, this year’s event is set to be the largest meeting in the organization's history. With over 450 high-impact sessions and thousands of specialized interactions, the gap between available insight and
Coolbrook Named on the 2026 Global Cleantech 10015.1.2026 19:14:00 EET | Press release
Coolbrook, a transformational technology and engineering company on a mission to decarbonise major industrial sectors like petrochemicals and chemicals, iron and steel, aluminium, and cement, has been named on Cleantech Group’s 2026 Global Cleantech 100. This annual list recognizes companies poised to deliver market-ready solutions that advance a cleaner, more resilient global future. The report highlights innovators addressing some of the world’s most urgent environmental and infrastructure challenges. The complimentary report introduces you to innovators advancing groundbreaking technologies and business models to enable us to act on the ever-increasing climate and environmental crisis. Following a 2025 marked by geopolitical volatility and shifting economic signals, the global cleantech ecosystem enters 2026 with slightly greater certainty - yet heightened competitive pressure. Growth is concentrating around two dominant themes: AI infrastructure and critical minerals. “The 2026 Glo
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