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
Taiwanese ensembles showcase erhu and ocarina at Prague Folklore Days23.7.2026 11:21:00 EEST | Press release
The Prague Folklore Days 2026 was held on July 17 and 18 in the heart of Prague, bringing together 56 international arts groups from Germany, Austria, Slovakia, Spain, the Netherlands, and Poland. Four Taiwanese groups took part: Hildebrand Yu’s ocarina band, the Shi-xian Huqin Orchestra, the Taipei Folk Orchestra, and the Four Strings Ensemble. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722841530/en/ Taiwanese ensembles showcase erhu and ocarina at Prague Folklore Days Led by Huang Chun-sin, the official Taiwan representative band featured a diverse lineup of ocarina, erhu, and dance performers. Their program stood out among the European groups with its distinctive character and vivid stage presence. Hildebrand Yu’s ocarina band captivated audiences with warm, uplifting melodies accompanied by the ocarina and ukulele. Yu also performed “Twilight Waltz,” delivering a heartfelt piece of poetic expression, like sunlight
Taiwan Children’s Choirs Garner Major Awards at Hungarian Choral Competition23.7.2026 10:33:00 EEST | Press release
Competing against 36 leading contenders from 20 countries, four Taiwanese children’s choirs have garnered several major awards and top honors at the 5th Budapest International Choral Celebration, showcasing Taiwan’s cultural diversity and music excellence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722613876/en/ Puzangalan Children’s Choir and Yo Wu Wei Children’s Chorus join forces with international choral ensembles and orchestras to perform Mozart’s Requiem Mass in D minor, K. 626 at the Béla Bartók National Concert Hall of Müpa Budapest. With its pure, angelic voices and exceptional vocal techniques, Puzangalan Children’s Choir from Pingtung County won the top prize, Laurea Summa Cum Laude, in the Grand Prix Competition’s Youth Choir of Equal Voices, Folklore, and Sacred Music categories. In the Open Competition, Yo Wu Wei Children’s Chorus claimed three gold prizes in the categories of Youth Choir of Equal Voices
Evotec Selects Navan to Unify Global Travel, Payments, and Expense Management23.7.2026 10:00:00 EEST | Press release
Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced that Evotec (NASDAQ: EVO; Frankfurt Prime Standard: EVT), the global drug discovery and development company, has selected Navan to manage its complete corporate Travel and Expense (T&E) program in its top global markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722261092/en/ Global drug discovery leader partners with Navan to drive operational excellence and eliminate manual expense reporting A life science company that is pioneering the future of drug discovery and development, Evotec had historically managed T&E independently across different countries, meaning employees were dealing with a patchwork of different tools and manual offline processes. As part of its focus on operational excellence, Evotec is further streamlining these processes through one unified, easy-to-use platform that supports consistency, transpar
Freedom Holding Corp. Works With Ant International’s Antom to Simplify Online Shopping From China for Kazakhstan Consumers23.7.2026 08:30:00 EEST | Press release
On July 16, 2026, during a meeting between Timur Turlov, CEO of Freedom Holding Corp., and representatives of the global fintech market, the bank signed Memoranda of Understanding with Antom, a leading merchant payment and digitisation services provider under Ant International. The primary goal of this partnership is to develop innovative solutions to facilitate cross-border payments for consumers in Kazakhstan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722367119/en/ From left to right: Timur Turlov, CEO of Freedom Holding Corp., Leiming Chen, Senior Vice President and Chief Sustainability Officer of Ant International Antom will promote Freedom Bank SuperApp as a supported payment option on China’s leading e-commerce platforms. This move aims to create a seamless cross-border online shopping experience, allowing consumers in Kazakhstan to shop for Chinese goods and global brands using their preferred local payment me
Galderma Reports Record First Half 2026 Net Sales of 3.134 Billion USD and 24.6% Year-on-Year Growth at Constant Currency, Raises Net Sales Guidance for the Full Year23.7.2026 08:00:00 EEST | Press release
Galderma Group AG (SIX: GALD), the pure-play dermatology category leader, today announced its financial results for the first half of 2026. Net sales reached 3.134 billion USD, surpassing 3 billion USD for the first time in the first six months of the year and representing net sales growth of 24.6% at constant currency1. Broad-based, double-digit growth in both International markets and the U.S. as well as in all product categories, primarily driven by volume and complemented by favorable mix. Outperforming the market in each product category, with net sales growth year-on-year at constant currency of 12.1% in Injectable Aesthetics, 16.4% in Dermatological Skincare, and 67.9% in Therapeutic Dermatology. Demonstrating leadership in dermatology through ongoing geographic expansion and differentiated innovation, including Nemluvio® (nemolizumab), which generated 433 million USD in net sales, Relfydess™ (RelabotulinumtoxinA), which continues to ramp-up with approvals in 33 International ma
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