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
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
Kinaxis Announces Board Transitions and Management Update2.1.2025 13:00:00 CET | Press Release
Kinaxis® Inc. (“Kinaxis ” or the “Company ”) (TSX: KXS), a global leader in end-to-end supply chain orchestration, has, effective January 1, appointed Lynn Loewen to the Company’s Board of Directors and member of the Audit Committee. Due to current commitments, Betsy Rafael will not be seeking re-election to the Board at the 2025 annual general meeting. “I’m pleased to add an exceptionally qualified Director in Lynn, who will ensure we maintain the strength of the audit oversight function, while bolstering the Board in a number of ways,” said Robert (Bob) Courteau, chair and interim chief executive officer. “Betsy has been an exceptional board member and we fully respect that she has several other professional and personal commitments that are taking her time. We appreciate her significant efforts and contributions and wish her the very best.” Ms. Loewen is an accomplished business leader who has held several leadership positions, including at Bell Canada and Air Canada Jazz, as well a
Computershare Acquires CMi2i2.1.2025 12:09:00 CET | Press Release
Computershare Limited (ASX: CPU) has announced that it has acquired CMi2i Limited. CMi2i provides independent and trusted advice to boards, executives and advisors of some of the largest public companies around the world. The company’s investor intelligence services, including its bondholder offering, help companies to identify and engage with investors on complex, contested and high stakes issues. It employs around 20 people in London and has a presence in New York, Milan and Madrid. Fiona Chalmers, CEO Issuer Services at Computershare said: “Bringing CMi2i into the Computershare Group is an exciting development that will enhance our investor relations offering to clients. “The acquisition further demonstrates our commitment to giving companies around the world the edge in the increasingly crucial area of shareholder engagement and ownership intelligence. “CMi2i’s approach to capital markets is very well respected, and their services and systems will complement our wider offering very
Aeromexico Named the Most On-Time Global Airline in 2024:2.1.2025 11:00:00 CET | Press Release
Cirium, the world’s most trusted source of aviation analytics, today announced the winners of its 2024 On-Time Performance Review, celebrating airlines and airports that excelled in on-time and operational performance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250101214982/en/ Cirium On-Time Performance Review 2024 (Photo: Business Wire) Cirium’s Annual report is the gold standard for global airline and airport performance analytics. An on-time flight is defined as a flight that arrives within 14:59 minutes of the scheduled gate arrival time. Airports measure punctuality as departing flights within 14:59 minutes of their scheduled departure time. Mexico’s Flag Carrier Tops Global Rankings Aeromexico claimed the prestigious title of the most On-Time “Global Airline” in 2024, achieving an impressive On-Time performance rate of 86.70%. Saudia followed closely as the runner-up with 86.35%, while Delta Air Lines secured thir
PQE Group Joins Project-COMFORT to Advance Patient-Centric Blood Collection and Diagnostics30.12.2024 07:50:00 CET | Press Release
PQE Group, a global consulting firm specializing in Life Sciences, is proud to contribute its expertise as a strategic partner in the Project-COMFORT consortium. This innovative public-private partnership, funded by Horizon Europe and supported by the Innovative Health Initiative Joint Undertaking (IHI JU), officially launched in November 2024, marking a transformative shift in blood collection and diagnostics. The ambitious 42-month project brings together 51 organizations from a broad spectrum of sectors, including academia, research institutions, hospitals, foundations, SMEs, medical technology, and pharmaceutical companies, all united by the mission to simplify, reduce the invasiveness of, and increase accessibility to blood collection through cutting-edge, patient-centered microsampling technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241229266268/en/ Follow Project-Comfort LinkedIn Page: https://www.linkedin.
Medical-Fish-Skin Company Kerecis Expands Silicone Fish-Skin Combination Product Range for Surgical and Trauma Wound with SurgiClose® Silicone27.12.2024 20:00:00 CET | Press Release
Kerecis, the company pioneering the use of sustainably sourced fish skin and fatty acids in cellular therapy and tissue regeneration and protection, today announced the availability of SurgiClose® Silicone, which combines a fish-skin graft and silicone backing for efficient treatment of surgical and trauma wounds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241227975454/en/ SurgiClose® Silicone (Photo: Business Wire) SurgiClose® Silicone is a part of the SurgiClose® product family, which is intact fish-skin intended for the management of trauma wounds and surgical wounds in the operating room. The new product is available in two variations, SurgiClose® Silicone Adhesive with borders that overlap the fish-skin underneath and SurgiClose® Silicone Standard with non-overlapping borders. “Applying Kerecis fish-skin to a surgical or trauma wound is a multi-step process that often requires supporting products such as sutures, st
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