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

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.com

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

Celebrating 25 Years of Sculptra ® : New Data and Recent Approval in China Cements Galderma’s Leadership in Regenerative Biostimulation4.11.2024 07:00:00 CET | Press Release

This monthmarks the 25th anniversary of the approval of Sculptra®, the first proven regenerative biostimulator with a unique poly-L-lactic acid (PLLA-SCA™) formulation.1-5,10-16 Sculptra works with the body’s natural processes to achieve healthier, radiant skin and a more youthful appearance, and has been a cornerstone of Galderma’s broad portfolio of proven aesthetic treatments.17,18 During its 25 years on the market, healthcare professionals have treated millions of patients with Sculptra, with distribution in over 40 countries and regions worldwide.10,12,19,20 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241103018007/en/ Pioneer in regenerative aesthetics: Working with the natural processes of the skin Regenerative aesthetics is an emerging and fast-growing trend in the field.21,22 It focuses on revitalizing the skin by engaging the body’s own healing mechanisms, working across three layers of the skin to restore and re

CRH Develops Wind Farm to Power Cement Plant in Romania1.11.2024 16:15:00 CET | Press Release

CRH (NYSE: CRH), the leading provider of building materials solutions, has developed a new wind farm to provide renewable electricity to its Medgidia Cement Plant in Romania. The wind farm is the first of its kind in the country to exclusively power a cement plant. It will meet a significant proportion of the Medgidia Plant’s annual energy requirements, helping to lower the carbon footprint of the products it produces, while also contributing to Romania’s clean energy transition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241101943296/en/ (Photo: Business Wire) Eunice Heath, Chief Sustainability Officer, CRH, said: “This is a significant clean energy project for CRH and is one of the many ways we are helping to create a more resilient and sustainable built environment. Building a wind farm to power one of our cement plants demonstrates our commitment to decarbonizing and providing lower carbon building materials solution

Adtran and Sonic Fiber Internet partner to deliver 50G PON connectivity across California1.11.2024 14:00:00 CET | Press Release

Adtran today announced its strategic collaboration with Sonic Fiber Internet to bring 50Gbit/s passive optical network (50G PON) connectivity to California. The partnership is a proactive step to ensure Sonic continues to deliver ultra-fast broadband services that meet the growing demand for higher capacity and faster speeds across the US. By leveraging Adtran’s 50G PON technology, Sonic aims to lead the industry in connectivity standards for both residential and business customers, enabling a range of applications from smart home integration and advanced entertainment streaming to frictionless remote work and high-speed business connectivity. The technology coexists with GPON and XGS-PON, providing a seamless and cost-efficient upgrade path with no service disruption, while future-proofing the network and ensuring scalability for evolving digital needs. It also supports Combo PON setups, integrating multiple generations of fiber technology to fully maximize deployment flexibility. Thi

MyGuava and Crystal Palace Launch Exciting Fan Payment Cards and Rewards1.11.2024 13:37:00 CET | Press Release

MyGuava in association with Crystal Palace Football Club is thrilled to launch exclusive Crystal Palace Fan Cards with rewards and a variety of perks as well as a unique opportunity for fans to celebrate their connection to the club while enjoying MyGuava’s seamless payment solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241101068560/en/ MyGuava and Crystal Palace Launch Exciting Fan Payment Cards and Rewards (Photo: Business Wire) Palace fans can now download the MyGuava App and order a Crystal Palace Card, choosing from three custom-designed cards: ‘Palace Gold’, ‘Palace Sash’ and ‘Selhurst 100’. Each card comes packed with perks, including entry into exclusive prize draws, cashback on all purchases, giving Palace fans an opportunity to take advantage of the 7% cashback offer ahead of the festive period. Additionally, the cards come with Visa Platinum status for added financial flexibility. Furthermore, for the m

NielsenIQ (NIQ) appoints Steen Lomholt-Thomsen as Chief Commercial Officer1.11.2024 13:00:00 CET | Press Release

NIQ, the world’s leading consumer intelligence company, announced the appointment of Steen Lomholt-Thomsen as its new Chief Commercial Officer, effective November 1, 2024. Steen will drive client strategy and enhance global growth as NielsenIQ expands its capabilities to deliver mission-critical insights into the most holistic view of consumer shopping behavior. NIQ’s AI capabilities, together with its core data assets and unmatched global footprint, are uniquely positioned to give clients the Full View™: a holistic view of shopper behavior. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241101505660/en/ Steen Lomholt-Thomsen NIQ Chief Commercial Officer (Photo: Business Wire) Steen brings extensive experience leading revenue growth and operational excellence in complex global organizations, including BullWall, Clarivate, and Aveva, and has held leadership roles in companies including IBM, HP, and IHS (now S&P Global). He br

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