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
Donaldson Introduces Alpha-Pore™ Technology Platform for Extended Sterile Filtration Performance2.11.2026 16:35:00 EET | Press release
Donaldson Company, Inc. (NYSE: DCI), a leading worldwide manufacturer of innovative filtration products and solutions, today announced Alpha‑Pore™ technology, a next generation sterile filtration platform engineered to extend filter service life while maintaining critical process performance. Built for critical applications, Alpha‑Pore technology enables longer filter run time compared with competitive single- and dual-layer polyethersulfone (PES) membrane filters, while maintaining flow characteristics, sterility assurance, and process integrity.* The platform is designed to help manufacturers improve operational efficiency through fewer changeouts and more consistent performance over time. Engineered for Extended Performance Sterile filtration processes often require balancing run time with key performance parameters such as flow, differential pressure, and contaminant retention. Alpha‑Pore technology is designed to achieve all three. By optimizing pore structure and filter architect
Smartly Launches Intelligence Pro to Connect Campaign Planning, Performance and Incrementality2.11.2026 16:00:00 EET | Press release
Smartly, the AI-powered advertising technology company, today launched Intelligence Pro, a premium offering that brings together four capabilities to help marketers plan investment, understand true incrementality and determine where to spend their next dollar. Intelligence Pro connects causal inference models with planning tools to help marketers prove business impact and make faster decisions from increasingly complex data. “Marketing teams are inundated with data, but the challenge is identifying what signals are useful and turning them into a decision they can act on,” said Maxwell Tang, Chief Product Officer at Smartly. “Intelligence Pro brings forecasting, market context and state-of-the-art incrementality signals together to help marketers assess where to invest and what their media is contributing. As AI accelerates campaign execution, the quality of each decision matters more.” Intelligence Pro combines four capabilities within Smartly’s platform: Reach Planner helps teams comp
SBC Medical Forms Capital and Business Alliance with AtomicSoftware, Provider of the medicalforce Clinic Management Platform Used by 800+ Clinics in Japan2.11.2026 16:00:00 EET | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced that it entered into a capital and business alliance agreement on October 26, 2026, with AtomicSoftware Inc. (“AtomicSoftware”), the Tokyo-based provider of medicalforce, an all-in-one software-as-a-service (SaaS) platform for clinics. In connection with the alliance, SBC Medical has invested ¥600 million (approximately US$3.8 million) in AtomicSoftware’s Series C funding round. The two companies will co-develop AI features, beginning with a feature that supports physicians in preparing medical records. Key Highlights Proven platform: medicalforce is used by more than 800 clinics*1 in Japan, primarily self-pay clinics, with a clinic retention rate of 99.2%*2. Joint AI development: Features co-developed by the two companies will enhance medicalforce and be progressively incorpo
NetApp Completes Acquisition of PEAK:AIO to Accelerate Zettabyte-scale AI Deployments2.11.2026 15:00:00 EET | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced that it completed the acquisition of PEAK:AIO, a pioneer in next-generation metadata architecture and high-performance parallel file systems. With this acquisition, NetApp can leverage metadata services and parallel namespace innovations to power the fastest storage on the planet, NetApp Novus, to support zettabyte-scale file systems for the most demanding workloads of AI clouds and GPU-as-a-service providers. For the best AI infrastructure economics, organizations need to keep GPU resources continuously supplied with data without bottlenecks. The acquisition advances NetApp’s strategy for the next phase of AI infrastructure by bringing PEAK:AIO’s metadata and parallel file system expertise together with NetApp ONTAP, giving customers a path to AI-scale storage that combines high concurrency and massive namespace growth with the resilience, security, and operational simplicity enterprises already trust
HistoSonics Receives Regulatory Approval in Singapore, Advancing Expansion Across Asia-Pacific2.11.2026 15:00:00 EET | Press release
HistoSonics today announced that the company has received market authorization from Singapore’s Health Sciences Authority (HSA) for its Edison® Histotripsy System (under the device name HistoSonics Histotripsy System), marking another significant milestone in the company’s continued international expansion and creating new opportunities to advance access to histotripsy throughout the Asia-Pacific region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261102090757/en/ HistoSonics Edison® Histotripsy System The Edison System is a novel, non-invasive, image-guided platform that uses the mechanical properties of focused ultrasound, known as histotripsy, to mechanically destroy and liquefy unwanted tissue and tumors. The technology offers a fundamentally new approach to tissue destruction without the need for invasive procedures, radiation, or thermal energy. The Edison System is currently authorized for the destruction of liver
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