Business Wire

Thermo Fisher Scientific Updates Chromosomal Microarray Analysis Solutions to Comply with IVDR Regulation

Share

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.

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

Verimatrix To Showcase Mobile App Protection Platform at OWASP Events in Lisbon and San Francisco24.6.2024 18:45:00 EEST | Press release

Regulatory News: Verimatrix, (Euronext Paris: VMX, FR0010291245), the leader in powering the modern connected world with people-centered security, today announced its participation in two leading events organized by the Open Worldwide Application Security Project (OWASP). The following conferences will showcase the award-winning Verimatrix Extended Threat Defense (XTD) mobile app security solutions: OWASP Global AppSec Lisbon 2024 – June 24-28, 2024 Lisbon Congress Centre – Lisbon, Portugal https://lisbon.globalappsec.org/ OWASP Global AppSec San Francisco 2024 – September 23-27, 2024 Hyatt Regency San Francisco – San Francisco, California https://sf.globalappsec.org/ Bringing together those tasked with ensuring proper security for apps, the associated enterprise, as well as their app users, OWASP events serve as leading venues to illustrate the value and differentiation that comes with proactively deploying mobile app protections. Verimatrix XTD mobile app security solutions quickly a

Armis Named ‘Outperformer’ and ‘Leader’ in GigaOm Radar Report for Operational Technology Security for Second Consecutive Year24.6.2024 18:15:00 EEST | Press release

Armis, the asset intelligence cybersecurity company, today announced that it has been named a Leader and Outperformer in the 2024 GigaOm Radar Report for Operational Technology (OT) Security. This is the second year running is recognized as a Leader in the field of OT Security, cementing its status as a mature platform solution providing proactive end-to-end security for cross-vertical organizations looking for a cohesive approach to OT Security management. Armis scored multiple 5/5 perfect scores showcasing Armis’ customer-centric vision to deliver OT security built on deep asset context, proactive threat intelligence and total vulnerability management. From cost and ease of use to scalability and flexibility and certification, Armis was recognized for being built for smooth deployment in OT environments. “The on-going development of the Armis Centrix™ platform has enabled us to offer complete end to end OT security management from complete visibility, vulnerability remediation and ma

H.I.G. Capital Raises $1.3 Billion for Infrastructure Fund24.6.2024 16:30:00 EEST | Press release

H.I.G. Capital (“H.I.G.” or “the Firm”), a leading global alternative asset management firm with $64 billion of capital under management, is pleased to announce the closing of H.I.G. Infrastructure Partners (the “Fund”). The Fund closed with aggregate capital commitments of approximately $1.3 billion.1 H.I.G. Infrastructure Partners seeks to make control-oriented, infrastructure equity investments focused on the middle market segment, leveraging H.I.G.’s focus on the middle market and its operational value creation expertise. To date, across North America and Europe, the Fund has made seven investments, two of which are expected to close in Q3 2024. Sami Mnaymneh and Tony Tamer, Co-Founders of H.I.G., commented, “We greatly appreciate the strong support from our investors for our Infrastructure strategy. Their confidence in our investment approach to infrastructure underscores the power of the Firm’s platform and our ability to generate strong returns through value creation in the unde

Grid Dynamics Releases a GenAI Toolkit to Enhance Developer Productivity24.6.2024 16:15:00 EEST | Press release

Grid Dynamics Holdings, Inc. (NASDAQ: GDYN) (Grid Dynamics), a leading provider of technology consulting, platform and product engineering, AI, and advanced analytics services, unveils its AI for Developer Productivity Toolkit. This toolkit provides specialized applications for common software development scenarios including application modernization, functional test automation, and cloud deployment observability. These purpose-built tools enable development teams to solve corresponding problems faster and more efficiently than general-purpose coding LLMs and copilots. This release includes three new tools to address three in-demand use cases across Grid Dynamics’ client base. The first tool, AI Application Modernization, performs architectural analysis of legacy applications, generates detailed specifications for the target technology stack, and implements these specifications in the code. The second tool, AI Test Automation, enables end-to-end functional test generation by analyzing

Adtran and Iridium strengthen PNT resilience in Europe and Asia-Pacific with Satellite Time and Location technology24.6.2024 15:00:00 EEST | Press release

Adtran, in partnership with Iridium Communications Inc. (NASDAQ: IRDM), today announced the European and Asia-Pacific launch of its synchronization solutions featuring Iridium® Satellite Time and Location (STL) technology, a significant step in countering growing threats to Global Navigation Satellite Systems (GNSS). Adtran’s OSA 5405-S PTP compact grandmaster clock with STL capabilities and its OSA 5400 STL module are now available to timing network operators in Western Europe, major countries in Eastern Europe, Turkey, and parts of Asia-Pacific, including the majority of Southeast Asia, Japan and South Korea. The solutions enhance the resilience and reliability of critical infrastructure, such as 5G networks, defense systems and many more. Leveraging low-Earth orbit (LEO) satellites to deliver precise and secure positioning, navigation and timing (PNT) services, the devices ensure continuous synchronization even in environments where GNSS is compromised. As a certified Iridium partne

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
HiddenA line styled icon from Orion Icon Library.Eye