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
Horizon3 and Pax8 Expand Partnership to Bring Autonomous Security Testing to MSPs Across Europe16.10.2026 09:03:00 EEST | Press release
Horizon3, the AI-Native Proactive Security Company, today announced the expansion of its Pax8 partnership across Europe, bringing the NodeZero® Proactive Security Platform to the region’s managed service providers (MSPs) through the Pax8 Marketplace. The expansion enables partners to build recurring security services that help small and midsized businesses understand how attackers could compromise their environments, prioritize corrective actions, and verify remediation. Building on the companies’ North American marketplace launch, the European expansion makes autonomous offensive security testing accessible to more MSPs and the businesses they protect. Partners can use NodeZero to deliver initial assessments, support remediation engagements, and establish ongoing testing programs without conducting every penetration test manually. “MSPs are accountable for protecting their customers’ security, but a list of vulnerabilities does not tell them what is actually exploitable, and their lev
MSCI Launches a Consultation on a Proposal to Reclassify Indonesia from Emerging Market to Standalone Market Status16.10.2026 00:47:00 EEST | Press release
MSCI announced the launch of a consultation on a proposal to reclassify the MSCI Indonesia Indexes from Emerging Market to Standalone Market status. MSCI will announce its final decision by the end of June 2027 and may provide an interim update on market participant feedback during the consultation period. As part of the June 2026 Market Classification Review, MSCI reported that market participants had raised significant concerns regarding the investability of the Indonesian equity market, including persistent opacity in shareholding structures and suspected coordinated trading behavior. While the Indonesian authorities have announced reforms, including enhanced disclosure of shareholders with ownership above 1%, more granular investor classification disclosure, High Shareholding Concentration (HSC) reporting, and a roadmap towards a minimum free float requirement of 15%, institutional investors have emphasized the need for consistent implementation and evidence of sustained material i
Nekome: Nazi Hunter Unmasks Hitler’s Hyenas in New Trailer Ahead of Steam Next Fest Demo15.10.2026 22:38:00 EEST | Press release
ProbablyMonsters, an independent video game company creating original AA games with AAA sensibilities, today unveiled a new trailer for Nekome: Nazi Hunterat the Galaxies Autumn Showcase, pulling back the curtain on the game’s villains, Hitler’s Hyenas. Alongside the new trailer, ProbablyMonsters announced that Nekome: Nazi Hunter will participate in October’s Steam Next Fest, giving players their first opportunity to experience this violent odyssey of revenge with a free PC demo available on Steam from October 19 through 26. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014661905/en/ “Nekome is Vano’s story: an exploration of a young Romani man who has had everything taken away from him, and who decides to pick up a knife and exact revenge on his family’s murderers,” said Jeronimo Barrera, ProbablyMonsters’ General Manager and Game Director. “Each of Hitler’s Hyenas brandishes their own form of evil and presents a new a
The Estée Lauder Companies Announces BEAUTY&YOU India 2026 Winners and Marks Five Years of Advancing Indian Beauty Entrepreneurship15.10.2026 18:58:00 EEST | Press release
The Estée Lauder Companies, in partnership with Nykaa and Startup India, an initiative of the Department for Promotion of Industry and Internal Trade (DPIIT) within India’s Ministry of Commerce and Industry, announced the winners of BEAUTY&YOU India 2026, the country’s leading beauty entrepreneurship program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015612324/en/ (L to R) BEAUTY&YOU India 2026 Winners Ajaykumar Mehta, Shriya Rambhia, and Dheer Rambhia, Directors, Goyam Green Tech (BREAKTHROUGH), Nirja Bhatt, Founder & CEO, Laani (GROW), Khatija Shabana, CEO, and Syed Mohammad Fouzan, Director, Boldpurity (IMAGINE), Rinzing Choden Bhutia, Founder, Agapi Sikkim (Visionary Women’s Award), and Pankti Sheth, Founder & Creative Director, De Icebreaker Creative Studio (DESIGN). For five years, BEAUTY&YOU India has discovered, supported, and accelerated India’s next generation of beauty entrepreneurs. Since launching in 202
BioLab Holdings Launches EmeraNova™ to Advance the Future of Tissue Restoration15.10.2026 18:00:00 EEST | Press release
BioLab Holdings announced today a new, larger mission with the launch of EmeraNova™, a new corporate identity that reflects a broader ambition to advance tissue restoration across specialties, healing phases, and care settings. The launch marks the company’s efforts to build a global platform focused on identifying promising technologies and accelerating their path into clinical practice. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015721831/en/ EmeraNova seeks partners around the world to bring promising technologies to market quickly and equip clinicians with advanced, effective solutions. EmeraNova represents a vision to pursue emerging (Emer) and new (Nova) technologies by building an expanding toolbox of tissue restoration solutions, world-class support, and ways to bring together expert voices and clinical insights that will help shape what comes next. The company’s roots in chronic wound care will inform its fut
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