These enhancements represent Thermo Fisher's steadfast commitment to ensuring the highest standards of safety and efficacy in cytogenetic testing.

"Thermo Fisher's dedication to advancing chromosomal microarrays underscores our ongoing mission to empower laboratories with cutting-edge technology," stated Kevin Lowitz, Vice President and General Manager of Microarray at Thermo Fisher Scientific. "By aligning the CytoScan Dx Assay kit and ChAS Dx software with IVDR requirements, we're equipping our EU customers with tools to uphold patient safety and meet regulatory mandates seamlessly."

The evolution of chromosomal microarrays (CMAs) has revolutionized cytogenetics testing, offering unparalleled insights into genetic disorders crucial for reproductive health assessments. As an in vitro diagnostic CMA test tailored for postnatal analysis, the CytoScan Dx Assay facilitates the identification of genetic underpinnings behind neurological and dysmorphic disorders in children. Leveraging advanced technology, the assay boasts enhanced resolution and coverage, outperforming conventional methods and boosting diagnostic yield by an impressive 12.5%.

Complementing the CytoScan Dx Assay, the ChAS Dx software streamlines cytogenetic analysis, visualization, and reporting of chromosomal aberrations throughout the genome. With comprehensive support for CytoScan Dx Arrays, ChAS Dx offers flexible parameters, diverse data formats, and seamless integration with leading genetic databases. This sophisticated data analysis tool is provided to all CytoScan Dx customers at no additional charge.

The fully compliant CytoScan Dx Cytogenetics Suite encompasses the CytoScan Dx Array, a reagent kit, the Applied Biosystems™ GeneChip™ System 3000 Dx platform for array processing, and the user-friendly ChAS Dx software. This comprehensive suite represents a complete sample-to-insight solution for cytogenetic laboratories.

Thermo Fisher Scientific remains committed to driving innovation and supporting laboratories worldwide in their pursuit of excellence in cytogenetics testing.