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
AI Investment Is Surging, but Businesses Are Struggling to Prove the Value, HTEC Global Study Finds15.10.2026 11:42:00 EEST | Press release
HTEC, a global product engineering and AI transformation company, today launches The HTEC AI Value Realization Report 2026, revealing a new challenge emerging as organizations move beyond AI experimentation: investment is accelerating faster than many companies’ ability to measure, govern and consistently realize its value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015407055/en/ HTEC, a global product engineering and AI transformation company, today launches The HTEC AI Value Realization Report 2026, revealing a new challenge emerging as organizations move beyond AI experimentation: investment is accelerating faster than many companies’ ability to measure, govern and consistently realize its value. The independent study finds that 79% of organizations have increased AI investment over the past year, with spending rising by 31% on average. Yet 77% of executives now believe AI value is constrained more by people and pr
Flowdesk Europe Receives Payment Institution Authorization from the ACPR Under PSD215.10.2026 10:30:00 EEST | Press release
Flowdesk, a global liquidity provider and digital asset trading and infrastructure provider, today announced that its European entity, Flowdesk Europe, has been authorized as a Payment Institution by the French Prudential Supervision and Resolution Authority, l'Autorité de contrôle prudentiel et de résolution (ACPR), under the second Payment Services Directive (PSD2). The authorization allows Flowdesk Europe to provide custody and transfer services for e-money tokens (EMTs), the fiat-referenced stablecoins regulated under the Markets in Crypto-Assets (MiCA) regulation, to its clients across the European Union. The authorization follows the entity’s Crypto-Asset Service Provider (CASP) authorization received from the Autorité des Marchés Financiers (AMF) under MiCA at the end of June this year. With both authorizations in place, Flowdesk Europe can now support its EU clients across the trading, custody, and transfer of crypto-assets and EMTs, reflecting the firm’s long-standing commitme
Too Good To Go Expands Its Marketplace Beyond Food15.10.2026 10:30:00 EEST | Press release
Too Good To Go, the world's largest marketplace for surplus food, today announced that it is expanding its Marketplace beyond food, enabling retailers to redistribute surplus across personal care — including skincare, haircare, oral care and beauty products — pet care, flowers and plants, nutrition and supplements, and home, initially spanning cleaning and laundry products and décor. More than 8,500 stores already supply products across these areas, around one third of which were already working with Too Good To Go to redistribute surplus food. “In today’s society, we have built incredibly efficient processes for producing and selling things at scale, creating abundance, but we have not built the same efficiency into making sure what is left over gets used. As our lives have become more convenient, we have become less conscious of what those things are worth. We used to finish what was on the plate, find a use for what we had and instinctively pause before throwing something away. Too
From AI to Autonomous Networks: Mobileum Spark Highlights the Next Frontier of Telecom Intelligence15.10.2026 10:00:00 EEST | Press release
Mobileum Inc. ("Mobileum"), a leading global provider of telecom analytics and network solutions, brought together telecom operators and industry leaders during its Mobileum Spark events series in Lisbon (Portugal) and Frankfurt (Germany), to explore how Artificial Intelligence (AI), Agentic AI and automation are transforming network operations and accelerating the evolution toward autonomous networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015172815/en/ Telecom operators, industry leaders, and Mobileum experts at Mobileum Spark 2026. Focused on Risk Management & Fraud Prevention and Network Testing & Assurance, the events featured customer-led discussions, expert insights, and real-world use cases demonstrating how AI and advanced automation are helping operators address increasing network complexity, strengthen fraud prevention, improve service assurance, and drive operational efficiency. A central theme across
Merz Therapeutics Announces Completion of Recruitment in Two Phase III Trials Investigating XEOMIN ® (incobotulinumtoxinA) for Migraine Prevention15.10.2026 09:00:00 EEST | Press release
Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, today announced the completion of patient recruitment in two global Phase III clinical trials, MINT-E (NCT07018700) and MINT-C (NCT07018713), evaluating the efficacy and safety of XEOMIN® (incobotulinumtoxinA) for the prevention of episodic and chronic migraine in adults. The trials recruited approximately 1800 adults across 109 study sites in North America and Europe. Migraine affects around 1.1 billion people worldwide, posing a significant burden on patients, society and healthcare systems.1 Both trials are evaluating the change in monthly migraine days from baseline to Month 6 as the primary endpoint. Secondary endpoints include changes in monthly headache days, acute medication days and migraine frequency during two-week periods at the end of each injection cycle. “Achieving patient recruitment for both MINT-C and MINT-E six months ahead of plan is an important milestone for our XEOMIN® migraine preven
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