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
Vertex to Acquire Crinetics Pharmaceuticals6.7.2026 23:04:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases, today announced that the companies have entered into a definitive agreement under which Vertex will acquire Crinetics for $85.00 per share in cash, for a total equity value of approximately $10.0 billion, or approximately $8.8 billion net of estimated cash acquired. The transaction was unanimously approved by both the Vertex and Crinetics Boards of Directors and is anticipated to close in the third quarter of 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706876183/en/ Crinetics’ marketed medicine, PALSONIFY® (paltusotine), received approval from the U.S. Food and Drug Administration (FDA) in September 2025. PALSONIFY was recently approved by the European Medicines Agency (EMA) a
Ciauru Wins the Second Edition of the Reply AI Music Contest, the International Competition Dedicated to Experimentation Across AI, Music and Live Performance6.7.2026 21:30:00 EEST | Press release
The second edition of the Reply AI Music Contest, the international competition created by Reply to explore new forms of expression combining artificial intelligence, music and live performance, concluded with the announcement of the winner on the Nova Stage powered by Reply during Kappa FuturFestival. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706007611/en/ The second edition of the Reply AI Music Contest, the international competition created by Reply to explore new forms of expression combining artificial intelligence, music and live performance, concluded with the announcement of the winner on the Nova Stage powered by Reply during Kappa FuturFestival First place went to Ciauru, the stage name of Simone Privitera, an Italian multi-platinum DJ and producer who integrates artificial intelligence tools into a musical practice rooted in the contemporary electronic scene. With a career that has seen him collaborate wit
Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 20266.7.2026 16:00:00 EEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced it will report earnings after market close on July 30, 2026. The company will host a conference call and webcast on that date to discuss the second quarter 2026 results and the second half 2026 outlook at 5:00 p.m. Eastern / 2:00 p.m. Pacific time. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706560476/en/ Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 2026 A live webcast of the event will be available on Rimini Street’s Investor Relations site via the Rimini Street IR events link and directly via the webcast link. Dial-in participants can access the conference by dialing 1-800-836-8184. A replay of the webcast will be available for one year following the event. About Rimini Street, Inc. Rimini Street, Inc. (Nasda
Orion and Shilpa Medicare Expand Partnership to Develop and Supply Nivolumab Biosimilar for Europe6.7.2026 16:00:00 EEST | Press release
Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Orion Corporation for intravenous (IV) nivolumab biosimilar referencing one of the world’s most widely used cancer immunotherapies to widen patient access across Europe. Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients with cancers such as melanoma and lung cancer. As the originator approaches loss of exclusivity in Europe, this partnership aims to put a high-quality, EU-GMP-manufactured nivolumab biosimilar within reach of more patients, reducing healthcare burden. In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe — underscoring the scale of the opportunity. Under the agreement, Orion will hold the exclusive rights to register, market, distribute and sell the nivolumab biosimilar across Europe. Shilpa Biologicals will lead product developm
No-Loss Trading Platform UpsideOnly Surpasses 100,000 Users Within Weeks of Launch6.7.2026 15:48:00 EEST | Press release
Perpetuals.com Ltd (Nasdaq: PDC), today announced that UpsideOnly, its risk-free trading and market prediction platform, has seen a surge in new user sign-ups, surpassing the important milestone of 100,000 traders within weeks of its launch on May 19. UpsideOnly lets users make predictions about where global equity, commodity, forex, and crypto markets are heading without ever placing a real trade themselves. Perpetuals uses its own capital to trade on the strongest signals identified by its proprietary AI. If those trades win, Perpetuals shares the profits with the users who helped generate the signal. If the trade doesn’t make money, users lose nothing. Reaching 100,000 users so quickly after launching is a reflection of the enormous demand for a platform that flips the traditional retail trading model on its head, with early platform data showing strong engagement across asset classes, geographies and user activity: Users from more than 180 different countries $38.4 billion in cumul
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