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
OCP Announces Date of Second Quarter and First Half 2026 Earnings22.9.2026 17:00:00 EEST | Press release
OCP S.A. (“OCP” or the “Company”), a global leader in the fertilizer industry, will release its second quarter and first half 2026 results on Tuesday, September 29, 2026. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal from 10:00 a.m. EDT, 2:00 p.m. Morocco (GMT) and 3:00 p.m. London time (GMT+1). OCP senior management will host a conference call to discuss second quarter and first half 2026 results at 11:00 a.m. EDT, 3:00 p.m. Morocco (GMT) and 4:00 p.m. London time (GMT+1) on Tuesday, September 29, 2026, for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing g.laraki@ocpgroup.ma. About OCP OCP is a global leader in the fertilizer industry, backed by almost a century
Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 202622.9.2026 16:30:00 EEST | Press release
Takeda(TSE:4502/NYSE:TAK)announced that new data from its oncology pipeline and portfolio will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 23-27, 2026, in Madrid, Spain. Key data will include a late-breaking abstract on arcotatug tavatecan (TAK-921; Innovent R&D code: IBI343*) and two presentations on TAK-928 (Innovent R&D code: IBI363*). Clinical and real-world analyses of ALUNBRIG® (brigatinib) and FRUZAQLA® (fruquintinib) will also be shared at the congress. “Takeda’s data at ESMO reflect our commitment to delivering rapid progress for patients living with some of the most prevalent and challenging cancers, including advanced gastric cancer and immunotherapy-resistant and previously untreated non-small cell lung cancer,” said Phuong Khanh (P.K.) Morrow, M.D., Head of the Oncology Therapeutic Area Unit at Takeda. “Our mission is to advance new therapeutic approaches for patients who need more options or who remain underserved by cur
Quaise Energy Selected for Up to $25 Million in U.S. Department of Energy Support to Advance World's First Commercial Superhot Geothermal Power Plant22.9.2026 16:30:00 EEST | Press release
Quaise Energy, a leading developer of utility-scale superhot geothermal energy, today announced that it has been selected by the U.S. Department of Energy (DOE) for up to $25 million in funding under the Next-Generation Geothermal Field Tests and Geothermal Resource Characterization and Confirmation funding opportunity. The support brings the U.S. closer to commercializing superhot Enhanced Geothermal Systems — technology that could unlock firm, clean power from hot rock beneath virtually any geography in the country. The funding will advance Project Obsidian, the world's first commercial superhot geothermal power plant, in Central Oregon. It will support analysis of the drilling, stimulation, and flow results of the first two wells to optimize a third well at the Obsidian site. The three-well configuration is targeting average reservoir temperatures of over 300°C and is designed to demonstrate more than 25 megawatts of gross electric power capacity. The DOE funding will also enable Qu
From CSR to Public Health Impact: How Colgate Bright Smiles, Bright Futures® is Driving Behavior Change for the Next Billion Children and Their Families22.9.2026 16:00:00 EEST | Press release
Colgate-Palmolive, the worldwide leader in oral care, announced a strategic evolution in its flagship oral health education program, Colgate Bright Smiles, Bright Futures® (BSBF), reflecting the Company’s commitment to global public health. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260922129016/en/ Launched in 1991, the program has reached over two billion children and their families across more than 100 countries, demonstrating how private-sector commitment designed to support communities, can become a powerful force for public health, driving healthier behaviors and positive outcomes at scale. From health education curriculum and school programming to mobile dental vans and free oral health screenings, BSBF helps children and their families access care, adopt healthier habits, and improve long-term oral health outcomes. “At Colgate-Palmolive, we believe oral health and healthier, brighter futures are inextricably link
Incyte Data at the European Academy of Dermatology and Venereology (EADV) Congress Underscore the Breadth of Incyte’s Inflammation and Autoimmunity Portfolio22.9.2026 15:30:00 EEST | Press release
Incyte (Nasdaq:INCY) today announced that data from across its Inflammation and Autoimmunity (IAI) portfolio will be presented at the European Academy of Dermatology and Venereology (EADV) 2026, held September 30 - October 3, 2026, in Vienna, Austria. "The breadth of research being presented at EADV 2026 highlights the strength of our Inflammation and Autoimmunity portfolio," said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. "Data presentations in hidradenitis suppurativa, atopic dermatitis and prurigo nodularis demonstrate our commitment to advancing innovation across immune-mediated skin diseases and deepening our understanding of the patient experience." Details on key Incyte data presentations at EADV include: Oral Presentations Atopic Dermatitis Atopic Dermatitis and Life Course Disruption: Evidence From a Multidimensional International Survey (TOPiQAL) (Session: Free Communication 1: Atopic dermatitis/Eczema. Thursday, October 1, 2:50-3:0
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