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
Coulson Aviation Defines the Next Chapter of Innovation With EmberWorks10.9.2026 15:03:00 EEST | Press release
Coulson Aviation is moving forward with EmberWorks, its dedicated innovation division created to turn real-world operational challenges into new capabilities for aerial firefighting, aviation, and emergency response. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910644135/en/ Comparison imagery demonstrates how ORBIT uses airborne thermal sensing and automated processing to identify wildfire activity and generate geolocated fire intelligence. First introduced at the Aerial Fire Fighting Global Conference in Rome earlier this year, EmberWorks formalizes an approach to innovation that has existed throughout Coulson’s history. From aircraft modification and mission-system development to programs such as C-130 airtanker, Boeing 737 Fireliner, and CH-47 Chinook helicopter, Coulson has long developed solutions in response to real-world operational needs. EmberWorks builds on that history by giving this approach a dedicated str
Radisys Launches V.AI Ecosystem to Accelerate Telecom AI Service Innovation10.9.2026 15:00:00 EEST | Press release
Radisys® Corporation, a global leader in open telecom solutions, today announced the launch of its V.AI ecosystem, bringing together applications, development tools and leading voice and speech AI technologies to help telecom operators create, deploy and monetize AI-powered communication services for consumers and business subscribers. The V.AI ecosystem, which has evolved since the launch of the Radisys Engage Digital Platform (EDP) at MWC Barcelona in 2022, draws on two decades of Radisys leadership in real-time media processing and a global footprint across live operator networks. Seamlessly integrated with EDP, the ecosystem gives operators multiple paths to market. Operators can deploy turnkey applications, customize services for specific markets and customer segments, or create new device-independent, network-delivered experiences through V.AI Studio, Radisys’ development environment for voice and video AI services. Charter members of the V.AI ecosystem, ElevenLabs, Hiya, ReadSpe
BioLife Secures U.S. Patent for First-of-its-kind Effervescent Oral Peptide Delivery Technology10.9.2026 15:00:00 EEST | Press release
BioLife today announced that the United States Patent and Trademark Office has granted U.S. Patent 12,667,605 B2 for its novel effervescent oral peptide delivery technology, designed to support current and future peptide therapeutics for obesity, diabetes and metabolic disease. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910717829/en/ BioLife offers a new solution for oral GLP-1 delivery The announcement comes as demand for GLP-1 medicines continues to accelerate. GLP-1 therapies generated approximately $132 billion in global sales in 2025, while obesity medicines now represent an estimated $42 billion market.1 As more patients seek alternatives to injections, demand for alternative oral treatments continues to grow. First generation oral GLP-1 medicines have demonstrated the value of oral administration while also underscoring on the fundamental challenges in peptide drug development: protecting large peptide molecule
Netskrt to Showcase Media Over QUIC Work with Oracle at IBC 202610.9.2026 15:00:00 EEST | Press release
Netskrt, an independent content delivery network built for high-concurrency streaming events, today announced that it will showcase its work to advance Media Over QUIC (MOQ) at IBC 2026, taking place Sept. 11-14 at RAI Amsterdam. As part of the event, Netskrt will demonstrate with Oracle how independently operated CDN infrastructure can participate in a coordinated MOQ delivery path designed to bring live media closer to viewers. MOQ is an emerging IETF effort designed to support low-latency media delivery at scale, with live streaming among its primary use cases. Its relay-based architecture enables media to move through distributed infrastructure closer to audiences, creating new possibilities for reducing latency while efficiently serving highly concurrent live events. At IBC, Netskrt and Oracle will put that model into practice. An Oracle Video Edge (OVE) containerized relay running within Netskrt infrastructure will coordinate with Oracle’s relay network as part of an end-to-end M
Bending Spoons enters into a definitive agreement to acquire Miro for $1.355 billion10.9.2026 15:00:00 EEST | Press release
Bending Spoons S.p.A. (NASDAQ: BSP) has entered into a definitive agreement to acquire Miro at an enterprise value of $1.355 billion. Together with Miro’s net cash, this implies an equity value of approximately $1.79 billion. In connection with the all-cash transaction, certain Miro shareholders have agreed to invest $295 million of their proceeds into newly issued Bending Spoons equity. The acquisition, including the investment, is subject to customary closing conditions and approvals, including regulatory approvals. “It's a privilege, and no small responsibility, to welcome a product that over 250,000 organizations have integrated into their workflows,” said Luca Ferrari, Bending Spoons CEO and co-founder. “Miro has grown to around $600 million in annual recurring revenue, nearly 90% from business and enterprise customers. After closing, we plan to invest substantially in the fundamentals that its customers value: performance, reliability, and functionality that supports critical col
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