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Thermo Fisher Scientific Enhances Chromosomal Microarray Analysis Solutions for IVDR Compliance

NextEdge Admin

31 May 2024

2 min 16 sec

Thermo Fisher Scientific Inc. has announced that its Applied Biosystems™ CytoScan™ Dx Assay and Applied Biosystems™ Chromosomal Analysis Suite (ChAS) Dx software are now compliant with the In Vitro Diagnostic Regulations (IVDR) 2017/746 in the European Union. These updates aim to assist cytogenetics testing laboratories in adhering to the latest medical device safety and efficacy regulations.

Kevin Lowitz, Thermo Fisher Scientific’s vice president and general manager of microarray, highlighted the company’s dedication to innovation in chromosomal microarrays (CMAs), which has expanded cytogenetic testing capabilities. The CytoScan Dx Assay facilitates postnatal analysis, aiding in the identification of genetic causes underlying neurological and dysmorphic disorders in children. Compared to traditional methods, it offers higher resolution and broader coverage, enhancing diagnostic yield by 12.5%.

ChAS Dx software simplifies cytogenetic analysis, visualization, and reporting of chromosomal aberrations. It supports CytoScan Dx Arrays with whole-genome coverage and provides access to various external genetic databases, offering a comprehensive solution to customers.

The IVDR compliant CytoScan Dx Cytogenetics Suite includes the CytoScan Dx Array, a reagent kit, the Applied Biosystems™ GeneChip™ System 3000 Dx platform, and user-friendly ChAS Dx software.

Thermo Fisher Scientific, with an annual revenue exceeding $40 billion, aims to enable customers to improve global health, safety, and cleanliness. Their portfolio includes Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD, offering innovative technologies, purchasing convenience, and pharmaceutical services.