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
OPEX® Corporation Presented with Multiple DM Awards by Document Manager Magazine15.1.2026 11:00:00 EET | Press release
OPEX® Corporation, a global leader in Next Generation Automation providing innovative solutions for warehouse, document and mail automation, has been recognized by Document Manager magazine with multiple DM Awards. At the 2025 awards ceremony held recently in London, OPEX was named the winner in two categories―Imaging Product of the Year: High Volume and Hardware Product of the Year―for its Falcon+® document imaging solution. OPEX also received runners-up accolades, in partnership with Iron Mountain, in the category of Project of the Year: Public Sector, for their NHS Medical Scanning project. “OPEX is honored to receive such prestigious recognition from Document Manager magazine,” said Alban Collas, Director of EMEA Operations, OPEX. “Our team is committed to developing solutions that enable clients to transform how business is conducted. For our imaging solutions to be recognized in this way means so much to us. We’re especially pleased that the DM Awards honored our partnership with
SAP and Syngenta Announce Partnership to Scale AI-Assisted Agriculture15.1.2026 10:00:00 EET | Press release
SAP SE (NYSE: SAP) and Syngenta, a global leader in agricultural innovation, today announced a multi-year strategic technology partnership to accelerate AI-assisted innovation across Syngenta’s global operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115682130/en/ Jeff Rowe - CEO of Syngenta Group (left) and Christian Klein - CEO of SAP (right) The partnership will embed artificial intelligence at the core of Syngenta’s enterprise, modernizing operations and enabling accelerated innovation through advanced data analytics across the business — from manufacturing and supply chain to grower-facing products and services. Agriculture continues to navigate challenges driven by climate variability, supply chain complexity, and global uncertainty. By deploying AI-assisted tools enterprise-wide, this partnership positions Syngenta to meet the challenge of feeding a projected 10 billion people by 2050, while unlocking fast
NTT DATA Recognized as a Global Top Employer for Third Consecutive Year15.1.2026 10:00:00 EET | Press release
NTT DATA, a global leader in AI, digital business and technology services, today announces it has been certified as a Global Top Employer for 2026 by the Top Employers Institute. Recognized for the third year in a row, this prestigious honor places NTT DATA among a select group of just 17 organizations worldwide honored for consistently delivering a high-performing people strategy across its global operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115418660/en/ NTT DATA recognized as a Global Top Employer In addition to its global recognition, NTT DATA has also earned four Top Employer 2026 regional seals and 37 country and region seals across North America, Latin America, Asia Pacific, Europe and Africa. The Global Certification is the highest level of recognition offered by the Top Employers Institute and underscores NTT DATA’s ability to align its leadership, leverage data-driven insights and apply validated b
Advanced Sterilization Products (ASP) Announces CE Mark for ULTRA GI™ Cycle for Duodenoscopes in Partnership with FUJIFILM Healthcare Europe15.1.2026 10:00:00 EET | Press release
ASP International GmbH (“ASP”), a division of Fortive (NYSE: FTV), in collaboration with FUJIFILM Healthcare Europe GmbH, proudly announces that the ULTRA GI™ Cycle has received CE mark approval. The ULTRA GI™ Cycle is the latest innovation for the STERRAD™ 100NX Sterilizer with ALLClear™ Technology. The ULTRA GI™ Cycle’s receipt of the CE mark represents a pivotal advancement in elevating patient safety across healthcare facilities and addressing the complex challenges associated with traditional reprocessing methods. “This is a meaningful step forward in our mission to make duodenoscope reprocessing safer across Europe,” said Chad Rohrer, President, ASP. “By bringing hydrogen peroxide gas plasma sterilization into routine practice, we’re giving clinicians greater confidence to focus on what matters most – their patients.” ASP’s immediate focus is to work with medical device manufacturers to ensure that new duodenoscope models are designed to be compatible with hydrogen peroxide. The
AWS Launches AWS European Sovereign Cloud and Announces Expansion Across Europe15.1.2026 09:00:00 EET | Press release
Today, Amazon Web Services (AWS) announced the general availability of the AWS European Sovereign Cloud, a new, independent cloud for Europe entirely located within the EU, and physically and logically separate from other AWS Regions. The AWS European Sovereign Cloud’s unique approach provides the only fully featured, independently operated sovereign cloud backed by strong technical controls, sovereign assurances, and legal protections designed to meet the needs of European governments and enterprises for sensitive data. AWS also announced plans to extend the AWS European Sovereign Cloud footprint from Germany across the EU to support stringent isolation, in-country data residency, and low latency requirements. This will start with new sovereign AWS Local Zones located in Belgium, the Netherlands, and Portugal. From day one, AWS’s global cloud and AI infrastructure have been sovereign-by-design and provide customers with complete control over the location and movement of their data. Th
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