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
Lincotek Appoints New Global General Manager for Its Medical Division7.4.2026 11:08:00 EEST | Press release
Lincotek today announced the appointment of Gianluca Fioravanti as Global General Manager of its Medical Division - a global solution provider for the orthopedic market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407710572/en/ Gianluca Fioravanti, Global GM Lincotek’s Medical Division Reporting directly to Group CEO Andrea Colombo, Fioravanti assumed the role as of April 7 and will help drive the business forward. He will lead the development and execution of the company’s global growth strategy, while ensuring its seamless operational implementation across all regions. This strategic appointment reflects Lincotek’s commitment to enhance the value it delivers to customers, strengthening its ability to serve them better. Fioravanti brings more than 25 years of international experience to the Group, having held senior leadership roles across operations, engineering and general management in the medical sector. With a de
Toshiba’s Breakthrough Algorithm Harnesses Edge of Chaos to Dramatically Boost Performance of its Quantum‑Inspired Computer7.4.2026 10:00:00 EEST | Press release
Toshiba Corporation has developed a breakthrough algorithm that dramatically boosts the performance of the Simulated Bifurcation Machine (SBM), its proprietary quantum‑inspired combinatorial optimization computer. The new algorithm significantly improves the probability of obtaining an optimal solution or a known best solution within a limited number of trials—referred to as the success probability, a key benchmark for evaluating combinatorial optimization technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407918434/en/ Figure 1: Results demonstrating that the newly developed third‑generation SB algorithm can find the known best solution with nearly 100% probability at the edge of chaos for a fully connected 2,000‑spin Ising problem. The SBM is designed to solve large‑scale combinatorial optimization problems in a wide range of fields, including new drug discovery, delivery route optimization, and investment por
Budweiser Honors 40 Years of FIFA World Cup™ Legacy with Limited-Edition Collectible Pack and Nostalgia-Themed Platform7.4.2026 10:00:00 EEST | Press release
Today, Budweiser is celebrating 40 years as the Official Beer Sponsor of the FIFA World Cup™ with the launch of the largest limited-edition collectible pack ever – the Budweiser® FIFA World Cup™ Anniversary Pack* – bringing to life 11 bold design tributes to every tournament since 1986, and the centerpiece of a new nostalgia driven global platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407304059/en/ Budweiser® FIFA World Cup™ Anniversary Pack Throughout history, Budweiser has played an important role in some of football’s most unforgettable celebrations, from last-minute goals to trophy lifts seen around the world. These moments of “Budstalgia” [Budweiser + nostalgia] are the inspiration for the brand’s newest platform, brought to life through a new collectible design, a global film titled “The Big Drop,” distinctive out-of-home creative, and an era-inspired digital hub. “For 40 years, Budweiser has been part of
Ardabelle Reveals a €7 Trillion Challenge for Europe: Invest Now or Lose a Generation of Competitiveness7.4.2026 08:30:00 EEST | Press release
Europe is navigating a period of intense turbulence, where geopolitical crises, pressure on critical raw materials, and climate‑related shocks are reinforcing one another. This polycrisis is no longer cyclical: it is structurally reshaping the continent’s value chains and testing its industrial competitiveness. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260406787383/en/ Europe's Choice: €27T Coordinated Growth or €20T Fragmented Decline by 2050 In this context, Ardabelle is releasing Greening the Arteries of Industry, a groundbreaking study that quantifies for the first time the economic gap between a Europe that endures and a Europe that invests. Conducted under the scientific supervision of economist Xavier Jaravel, this work represents the first attempt to model, in an integrated way, industrial resilience, ecological transition, and European competitiveness through 2035 - 2050. The study was presented under the high
Tigo Energy Launches New GO Optimized Energy Storage System in European Residential Market7.4.2026 07:00:00 EEST | Press release
Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced availability of the Tigo GO Battery, a next-generation energy storage system and the latest addition to the Tigo GO optimized product line in Europe, joining the GO EV Charger and GO Junction for heat pump integration. The system delivers expandable energy storage capacity of up to 47.9kWh, faster installation via lightweight plug-and-play modules, and cold-weather operation down to -30°C. Installer preorders are currently available, with product shipping commencing in June 2026. The new GO Battery arrives as several European countries set new all-time single-day records for solar energy production, and global solar installations grew by 11% between 2024 and 2025. The Tigo GO Battery serves European market demand with an optimized modular architecture built on 3.68kWh battery units that installers can configure from 7.3kWh for compact installati
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