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
Niagen Bioscience Receives Exclusive U.S. FDA Rare Pediatric Disease (RPD) Designation and European Medicines Agency Orphan Medicinal Product Designation (OMPD) for NB4168 for the Treatment of Ataxia Telangiectasia (A-T)13.7.2026 15:32:00 EEST | Press release
Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced that the U.S. Food & Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its proprietary lead small molecule drug candidate NB4168 for the treatment of Ataxia Telangiectasia (A-T). NB4168 is an oral small molecule therapy engineered to deliver substantially greater nicotinamide riboside (NR) exposure than conventional NR while maintaining a differentiated pharmacokinetic and safety profile. In addition, the European Medicines Agency (EMA) has granted Orphan Medicinal Product Designation (OMPD) to NB4168 for the treatment of A-T, providing regulatory recognition in the European Union and further supporting the Company's plans to advance the program globally. The FDA granted RPD Designation based on its determination that A-T is a serious and life-threatening disease that primarily affects individ
Esri Introduces ArcGIS Velocity for ArcGIS Enterprise to Power Real-Time GIS Operations13.7.2026 15:00:00 EEST | Press release
Esri, the global leader in location intelligence, has released for general availability ArcGIS Velocity for ArcGIS Enterprise for self-hosted deployments on Windows and Linux. This enables organizations to leverage Velocity from secure on-premises and private cloud environments. Available as software as a service (SaaS) for ArcGIS Online and now for self-hosted environments in ArcGIS Enterprise, Esri’s next-generation geospatial capability delivers real-time analytics on streaming, Internet of Things (IoT), sensor, and asset data. It helps organizations track and visualize public events, supply chains, and infrastructure to identify and respond to potential threats. ArcGIS Velocity for ArcGIS Enterprise expands cloud-native support to enterprise customers across industries in government and business that rely on firewall protection and internal security compliance. ArcGIS Velocity connects to more than 20 ready-to-use feeds for real-time data providers, including Dataminr, Samsara, Fli
HistoSonics Receives CE Mark, Unlocking Access Across Europe and Accelerating Global Commercialization of the Edison® Histotripsy Platform13.7.2026 15:00:00 EEST | Press release
HistoSonics, today announced that the company has received CE Mark approval in Europe for its Edison® System, enabling commercialization of the company’s non-invasive histotripsy technology in Europe and other markets that recognize the CE Mark. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260713505048/en/ HistoSonics Edison® Histotripsy System The Edison System is a novel, non-invasive, image guided platform that is intended for the destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors. It uses the mechanical properties of focused ultrasound, called histotripsy, to liquefy and destroy unwanted tissue and tumors in a single procedure without the need for invasive procedures or radiation, and with potentially fewer side effects than traditional therapies. CE Mark approval follows an increasing number of regulatory clearances and was supported by a growing body of clinical ev
SLB OneSubsea Awarded EPC Contract for Eni’s Baleine Phase 3 Project Offshore Côte d'Ivoire13.7.2026 15:00:00 EEST | Press release
Global energy technology company SLB (NYSE: SLB) announced today that its OneSubsea™ joint venture has been awarded a major multi-well engineering, procurement, and construction (EPC) contract by Eni for Phase 3 of the deepwater Baleine project offshore Côte d’Ivoire. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260712734539/en/ SLB OneSubsea™ joint venture has been awarded a major multi-well engineering, procurement, and construction (EPC) contract by Eni for Phase 3 of the deepwater Baleine project offshore Côte d’Ivoire. Under the contract, SLB OneSubsea will deliver complete subsea production systems (SPS) for 13 wells, reinforcing its role as a core technology and execution partner on one of the most strategically significant offshore developments currently underway in the region. The EPC scope includes subsea trees, umbilical, manifolds, multiphase flowmeters and control systems, along with installation, commissionin
Agenus Announces Oversubscribed Private Placement of Up to $340 Million to Advance Registrational ROBBIN Trial of Neoadjuvant BOT+BAL in MSS Colon Cancer13.7.2026 13:00:00 EEST | Press release
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that it has entered into a securities purchase agreement for a private placement of approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and up to an additional $255 million upon the full exercise of purchase warrants. The financing was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals. The net proceeds of this financing are expected to support Agenus’ strategic prioritization of botensilimab and balstilimab (BOT+BAL) for the neoadjuvant treatment of microsatellite-stable (MSS) colon cancer, including advancement of ROBBIN1, the Company’s planned registrational Phase 3 neoadjuvant trial in microsatellite-stable (MSS) colon cancer. High-risk Stage II and Stage III MSS colon cancer affect an estimated 38,000 patients annually in the US and more than 200,000 patients worldwide,2 representing a
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