Thermo Fisher Scientific Inc., the world leader in serving science, announced  that their Applied Biosystems™ CytoScan™ Dx Assay and Chromosomal Analysis Suite (ChAS) Dx software now comply with the In Vitro Diagnostic Regulations (IVDR) 2017/746 in the European Union. This compliance will help cytogenetics testing laboratories meet the latest medical device safety and efficacy standards.

“Thermo Fisher’s commitment to innovation in chromosomal microarrays has advanced cytogenetic testing,” said Kevin Lowitz, vice president and general manager at Thermo Fisher Scientific. “The updates ensure high patient safety and regulatory compliance for our EU customers.”

Advancements in CMAs have enhanced cytogenetics testing, offering insights into genetic disorders and reproductive health. The CytoScan Dx Assay improves diagnostic yield by 12.5% over traditional methods, while ChAS Dx software provides comprehensive genome analysis and reporting. The IVDR compliant CytoScan Dx Cytogenetics Suite includes an array, reagent kit, processing platform, and user-friendly software.