Thermo Fisher Scientific Updates Chromosomal Microarray Analysis Solutions to Comply with IVDR Regulation
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
CORRECTING and REPLACING PHOTO Decode the Future of AI and Customer Experience at Elevate'25 Digital Innovation Summit18.9.2025 21:23:00 EEST | Press release
Please replace the photo with the accompanying corrected photo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918928987/en/ Gain insight and advice from firms at the frontier of AI-powered, mobile-first customer experiences. The release reads: DECODE THE FUTURE OF AI AND CUSTOMER EXPERIENCE AT ELEVATE'25 DIGITAL INNOVATION SUMMIT With keynotes from Google Cloud and an independent research firm, Elevate’25 will provide actionable strategies to harness the power of AI and create exceptional experiences for today's mobile-first consumer As unprecedented advancements in AI reshape consumer behavior, digital innovation summit Elevate'25 opened for general registration today. Sponsored by Airship, the exclusive, one-day event is designed to equip business leaders with proven strategies to harness artificial intelligence and mobile-first technology for a decisive competitive advantage. Taking place on October 15, 2025, at the i
Sai Life Sciences Opens Dedicated Facility for Veterinary APIs in Bidar, India18.9.2025 19:22:00 EEST | Press release
Sai Life Sciences (BSE: 544306 | NSE: SAILIFE), an innovator-focused Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the opening of Unit VI, a dedicated facility for Veterinary Active Pharmaceutical Ingredient (API) production, in Bidar, India. Located alongside Unit IV, the company’s flagship API manufacturing site, Unit VI has been established exclusively for veterinary APIs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918612071/en/ Sai Life Sciences’ Veterinary APIs Unit in Bidar, India. The new facility is designed to meet the highest standards of safety, sustainability, and regulatory compliance, ensuring the production of high-quality APIs for veterinary applications. With this expansion, Sai Life Sciences aims to provide efficient and scalable manufacturing solutions to leading global animal health companies. Making the announcement, Krishna Kanumuri, CEO & Managing Direct
Celltrion Announces Commercial Availability of Omlyclo™ Across Europe at EADV 202518.9.2025 18:45:00 EEST | Press release
Celltrion, Inc. today showcased its longstanding commitment to expanding its biosimilar portfolio in the field of immuno-dermatology by attending the 2025 European Academy of Dermatology and Venereology (EADV) Congress, held 17-20 September in Paris, France. Following the European Commission (EC) approval of Omlyclo™, the first and only omalizumab biosimilar in Europe in May 2024, Omlyclo™ will be commercially available starting in Norway, with subsequent rollouts in European countries. As part of Celltrion’s mission to advance knowledge and understanding in dermatology, especially in chronic spontaneous urticaria (CSU), the company hosted satellite symposium presenting the results of the global Phase III clinical trial of Omlyclo™. The global Phase III clinical trial involved 619 patients with CSU, following them up to week 40. Patients were randomized to receive 300 mg or 150 mg of Omlyclo™, or reference product, every 4 weeks. Starting from week 12, patients who received Omlyclo™ we
Setting the Standard: AMRA Medical Recognized as one of TIME Magazine’s ‘World’s Top HealthTech Companies’18.9.2025 17:40:00 EEST | Press release
AMRA Medical is proud to share its inclusion in the World’s Top HealthTech Companies list, published today by TIME in collaboration with Statista. This recognition positions AMRA among an elite group of global innovators that are leading healthcare transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918372780/en/ AMRA Medical Recognized as one of TIME Magazine’s ‘World’s Top HealthTech Companies’ The selection, which comes just one week after celebrating AMRA’s 15 years of progress and innovation within the body composition space, highlights AMRA’s long-standing commitment to becoming a global leader in health informatics. By delivering detailed, reproducible insights within fat distribution and muscle composition, AMRA’s MRI-based technology is helping clinicians, researchers, and healthcare organizations unlock new levels of understanding across the metabolic and musculoskeletal sectors. “Being recognized by
illumynt, a CNE Direct Company, Is Pleased to Announce the Promotion of Jörg Herbarth to Chief Executive Officer (CEO)18.9.2025 17:30:00 EEST | Press release
illumynt, a CNE Direct company, is pleased to announce the promotion of Jörg Herbarth to Chief Executive Officer (CEO). Jörg has been a key member of illumynt’s executive leadership team since joining in June 2022, most recently serving as Chief Operating Officer. In his new role as CEO, Jörg will spearhead illumynt’s mission to become the number one provider of AI- and data-centric IT Asset Disposition (ITAD) solutions worldwide. Paul Knight, illumynt’s current CEO, will transition to the role of Founder & Chairman. In this capacity, Paul will continue to support the executive team with strategic guidance, while Jörg assumes full leadership of day-to-day operations and global expansion initiatives. Mr. Knight had come out of retirement a year ago to undertake some new initiatives and advance the company's strategic direction. With some necessary changes having taken place- he is thrilled to facilitate this transition to a reduced role again. Under Jörg’s leadership, illumynt will cont
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