CA-THERMO-FISHER
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/
About Business Wire
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
NIQ Joins the Decentriq Network to Enable Secure Data Collaboration for Marketers and Agencies Across Europe16.9.2025 12:00:00 CEST | Press release
NIQ, a leading consumer intelligence company, is entering a strategic relationship with Decentriq to enable data collaboration for media use cases across Europe. Through the relationship, NIQ’s high quality consumer insights, including digital purchase data, will be available in Decentriq’s privacy-preserving clean rooms for the first time, enabling advertisers and agencies to utilize the data for audience profiling and closed loop measurement. Expanding beyond shopper insights NIQ is expanding its services to the data and media ecosystem through privacy-persevering clean rooms, opening up new opportunities for marketing and advertising agencies to enrich their first-party data insights, inform audience strategies, and measure sales outcomes. As Pierre Cholet, Chief Customer Officer at Decentriq, explains, “NIQ has long been a trusted name in understanding consumer purchasing behavior. Now, by integrating their data into Decentriq’s clean room, advertisers and agencies can leverage thi
Businesses Scale Transformation to Meet Regulatory, Technology and Customer Challenges, Finds Arthur D. Little Global Research16.9.2025 11:45:00 CEST | Press release
Transformation is now a way of life for global companies, with two-thirds (65%) undergoing wide-reaching or expanding organization-wide transformation initiatives. This is driven by regulatory change (including tariffs), technological disruption, and shifting customer needs, all of which are rated at 4.1/5 in importance. Confidence levels are high, with 95% expecting initiatives to deliver success, according to the inaugural Arthur D. Little (ADL) Global Transformation Study. Time frames vary significantly between regions. 71% have a four-to-six-year window for transformation, with 32% focused on five years. However, average timelines range from 3.2 years in North America to 4.9 years in the Middle East and 5.5 years in Asia-Pacific. There are also significant differences between who leads transformation efforts globally. While a third (32%) of companies have a Chief Transformation Officer (CTrO), adoption varies considerably by region. 53% of European companies have a CTrO, compared w
Reply Achieves the AWS Advertising and Marketing Technology Competency Thanks to the Contribution of the Data Reply and Storm Reply Teams16.9.2025 10:40:00 CEST | Press release
Reply [EXM, STAR: REY] has achieved the AWS Advertising and Marketing Technology Competency, the official recognition from Amazon Web Services certifying advanced technical and project expertise in the design and delivery of advertising and marketing solutions on AWS. This milestone was made possible thanks to the joint contribution of Storm Reply and Data Reply, both part of the Reply Group, with solid expertise in implementing cloud-native and data-driven solutions on the AWS platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250916374888/en/ With this certification, Reply’s companies specialized in AWS services further consolidate their role as trusted technology partners for organizations looking to evolve their marketing and communication strategies through the advanced use of AWS cloud and AI technologies. The AWS Advertising and Marketing Technology Competency validates the ability of AWS Partners to deliver hig
PayPay Is Now Accepted in South Korea via Ant International’s Alipay+16.9.2025 10:26:00 CEST | Press release
Connecting 70 million PayPay users to over 2 million South Korean merchants A milestone in PayPay’s overseas expansion Starting from late September 2025, Japan's leading cashless payment service PayPay will be accepted at over 2 million merchants across South Korea through Alipay+, a global wallet gateway service operated by Ant International. This will allow its 70 million registered users to make seamless payments during their visit, wherever the Alipay+ logo is displayed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250915612411/en/ Starting from late September 2025, Japanese travellers will be able to use PayPay to make payments in South Korea at stores displaying the Alipay+ logo. PayPay will show users the payment amount in Korean won and its yen equivalent in real time. This marks a new chapter in PayPay’s overseas expansion. From K-beauty stores and convenience chains to local eateries and cultural hotspots, from m
Talent shortages and AI pressures drive shifting dynamics in global technology leadership, According to Expereo16.9.2025 10:00:00 CEST | Press release
Skills gaps in networking, cybersecurity, and AI are delaying growth and forcing businesses to rethink leadership, training, and investment strategies Global businesses are facing mounting challenges in their growth ambitions due to persistent skills shortages in critical technology areas. As AI becomes more deeply embedded in business strategy, organisations are struggling to find or retain talent in key domains such as networking (39%), cybersecurity (40%), and Data/AI/automation (33%). The findings come from an IDC InfoBrief commissioned by Expereo, titled “Enterprise Horizons 2025: Technology Leaders Priorities: Achieving Digital Agility.” The report reveals that 39% of organisations are struggling to find or retain networking talent, while 33% report similar challenges in data, AI, and automation - figures that remain consistent with 2024 findings. These shortages are not only slowing down AI adoption but also reshaping leadership dynamics and workforce strategies across enterpris
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