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
Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting20.3.2026 16:00:00 EET | Press release
Incyte (Nasdaq:INCY) today announced that data from key programs in its Inflammation and Autoimmunity (IAI) franchise will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting, to be held March 27 – 31, 2026, in Denver. “At AAD 2026, we are presenting late‑breaking 54-week results from the Phase 3 STOP‑HS program evaluating povorcitinib in hidradenitis suppurativa (HS),” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. “These data provide longer term evidence of the safety and efficacy of povorcitinib in HS patients and further strengthen the significant growth potential of our Inflammation and Autoimmunity franchise.” Details on key data presentations at AAD include: Late-Breaking Oral Presentations Hidradenitis Suppurativa Povorcitinib in Patients With Moderate to Severe Hidradenitis Suppurativa: 54-Week Efficacy and Safety Results From the STOP-HS1 & STOP-HS2 Phase 3 Studies (Session: S034 – Late-Breaking Research: Sess
MUSASHI JAPAN by TAIMATSU Launches “Road to Shogun” – A Journey Through Craftsmanship and Discovery20.3.2026 14:58:00 EET | Press release
Musashi Japan by TAIMATSU Co., Ltd., a contemporary Japanese knife brand rooted in the spirit of craftsmanship and cultural harmony, has announced its newest experiential campaign: “Road to Shogun.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320887471/en/ Designed as the brand’s most ambitious customer journey to date, the campaign invites visitors to explore participating Musashi Japan stores while discovering the traditions, culture and craftsmanship that inspire the brand. Inspired by the journey towards mastery, the experience encourages participants to progress through a series of ranks whilst visiting stores and unlocking rewards that celebrate elements of everyday Japanese culture. At Musashi Japan, craftsmanship is not only about the final product, but also about the path taken to achieve mastery. The Road to Shogun reflects this philosophy by guiding customers through a journey that mirrors the dedication, cu
Futur Delivers Strong Growth and Record Profit in 202520.3.2026 13:05:00 EET | Press release
"2025 was a record year for Futur. In a market characterized by sharp market fluctuations, Futur continued to invest, grow and deliver strong results. Behind this record performance is stable customer growth, strong inflows and cost discipline. Our close cooperation with over 60 partners gives customers the freedom to choose the asset management and advisory services that best suit them. The strategy of letting the customer choose is appreciated, which is reflected in us welcoming more than 21,000 new customers during the year", says Torgny Johansson, CEO of Futur. "We are optimistic about the future. Futur has great opportunities to continue growing in the coming years by developing innovative and efficient services for savings and pensions. I am proud of how all employees have purposefully embraced our strategy and continue to work towards the goal of reaching 500 billion kronor in savings capital with the current organization", concludes Torgny Johansson, CEO of Futur. Key highlight
Lyten to Establish a Lyten Industrial Hub in Poland20.3.2026 13:00:00 EET | Press release
Lyten, the supermaterial applications company and global leader in an energy storage, has announced its interest in establishing a Lyten Industrial Hub in Poland. In 2026, Lyten will conduct a feasibility study to assess manufacturing requirements for Lyten products, potential private and public partnerships, and the necessary energy and utility infrastructure. The industrial hub will be built around Lyten Dwa – the energy storage production plant and R&D center in Gdańsk. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320045026/en/ Lyten Voltpack Mobile System in front of Lyten Dwa plant in Gdansk, Poland In February 2026, Lyten announced the establishment of its first Industrial Hub in Skellefteå, Sweden, on the site of the former Northvolt Ett plant, which it recently acquired. It will combine battery production with a data center with a capacity of up to 1 GW, being built by EdgeConneX. Once it reaches full production
PUMA Reveals Its Most Powerful International Football Kit Lineup yet on the Streets of New York City20.3.2026 09:00:00 EET | Press release
Global sports company PUMA unveiled its new national team kits for 11 nations with a street-level event at Domino Square in New York City, that placed football, music, food, and culture at the center stage in a celebration of the game. Rather than launching in a stadium setting or in a cinematic brand film, PUMA chose to reveal the kits in play, worn first by local community players from each nation on the streets of New York. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320641449/en/ Reinforcing its status as a leading force in football kits at this summer’s competition, PUMA unveiled jerseys for 11 nations, including the most prominent African partner federations of any brand in the tournament, in a community-first celebration of football, music, and culture in New York City. Four continents are united under 11 nations: Portugal, Morocco, Ghana, Paraguay, Senegal, Côte d’Ivoire, Czech Republic, Switzerland, New Zealan
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