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
MultiBank Group Named Forex Broker of the Year 2026 at Money Expo Abu Dhabi16.7.2026 14:35:00 EEST | Press release
MultiBank Group, one of the world's largest and most regulated online financial derivatives institutions, has been named Forex Broker of the Year at Money Expo Abu Dhabi. The event was held on 8–9 July 2026 at the ADNEC Centre. This flagship award recognizes the broker setting the benchmark for excellence across the global trading and fintech industry. MultiBank Group's participation in the expo underscored its leadership position within the Middle East's financial landscape. A Landmark Event for Trading and Fintech Money Expo Abu Dhabi 2026 brought together traders, banks, fintech firms, liquidity providers, and market leaders from across the region and beyond. Winning top honors on this stage sends a clear signal across the entire industry. “Being named Forex Broker of the Year is a defining moment for our Group,” said Johny Giacaman, Chief Business Operations Officer at MultiBank Group. “It reflects two decades of regulatory discipline, technological innovation, and an unwavering co
illumynt Appoints Anthony Giannetti as Senior Vice President of Global Operations16.7.2026 14:00:00 EEST | Press release
illumynt, a technology-driven leader in AI hardware lifecycle recovery and IT asset disposition (ITAD), today announced that Anthony "Tony" Giannetti has joined the company as Senior Vice President of Global Operations, effective July 13, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716696044/en/ Anthony Giannetti, SVP Global Operations Giannetti brings more than two decades of operations and supply chain leadership from some of the technology industry's largest OEMs, including Dell, where he managed reverse supply chain operations, and Apple and Microsoft, where he held additional operations leadership roles. His background spans production engineering, reverse logistics, and large-scale operational management, disciplines directly relevant to illumynt's work certifying and recovering value from retired AI infrastructure at scale. "Tony has spent his career on the operational side of exactly the problem we solve
Compvide ™ Announces Strategic Collaboration with OpZira ™ to Accelerate Growth and Advance the CIMED ™ Platform16.7.2026 13:47:00 EEST | Press release
Compvide, Inc., a biotechnology company pioneering functional complement intelligence through innovative diagnostics and immune-response monitoring, today announced a strategic collaboration with OpZira, Inc. to support the company’s continued growth and accelerate development of its proprietary CIMED platform. Through the collaboration, OpZira will provide comprehensive operational support across clinical, customer care, finance, manufacturing, marketing, quality, and regulatory functions,” stated Clark Tedford, Ph.D., President and CEO, OpZira, Inc. “By leveraging OpZira’s established operational infrastructure and expertise, Compvide can remain focused on advancing its scientific innovation while expanding its capabilities in complement-focused diagnostics and translational medicine.” “Partnering with an experienced organization that understands the unique needs of emerging healthcare companies is an important step for Compvide as we continue building the company,” said Sadam Yaseen
Compass Pathways Announces Publication of Post-Hoc Analysis Demonstrating Distinction of COMP360 Trial Monitoring & Support from Psychotherapy16.7.2026 13:35:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the publication of a post-hoc analysis of support methods used in an open-label Phase 2 study of investigational COMP360 synthetic psilocybin treatment in patients with post-traumatic stress disorder (PTSD). Documented speech production between participants and support providers during treatment administration sessions showed minimal interaction. Monitoring and support were linked by patients to presence, availability, reassurance and validation. The limited and non-directive nature of these interactions distinguishes this form of support from therapeutic dialogues typically used in conventional psychotherapy or other trauma-focused psychological treatments. “The monitoring and support we’ve incorporated across our COMP360 trials in both treatment-resistant depression and PTSD is designed to safeguard patients and protect d
Circus Commences Operations with Ukrainian Ground Forces16.7.2026 13:04:00 EEST | Press release
Circus SE (WKN: A2YN35 / ISIN: DE000A2YN355 / XETRA: CA1), today announces the commencement of live operations of its robotic-based troop supply technology with the 3rd Army Corps of the Ukrainian Ground Forces in the Kyiv area – marking the first ever use of autonomous meal supply systems within an active conflict environment. Ahead of deployment, Circus received regulatory certification from the State Service of Ukraine for Food Safety and Consumer Protection. This certification confirms compliance with all applicable health, quality, and safety standards required to import the company's technology into Ukraine, and clears the path for operational use at scale. Soldiers are supplied using Circus's full technology stack, comprising the hardware system, AI-controlled software, and proprietary ingredient infrastructure that underpins autonomous meal production in military environments. The deployment marks Circus's entry into the Ukrainian market and the operational commencement of the
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