Microarrays are an ideal solution for copy number variation (CNV) analysis and molecular cytogenetic testing in your clinical laboratory. The Applied Biosystems CytoScan Dx microarray platform is an in vitro diagnostic solution that offers a reliable genome-wide approach for high-resolution DNA copy number analysis to study gains, losses, loss of heterozygosity (LOH)/absence of heterozygosity (AOH), copy-neutral loss of heterozygosity (cnLOH), regions identical-by-descent, and mosaicism.
Our robust microarray platform, CytoScan Dx Cytogenetics Suite, is cleared by the US Food and Drug Administration (FDA) and compliant with the EU In Vitro Diagnostic Regulation (IVDR) 2017/746. It is designed to provide reproducible results and save time and money, while delivering quality performance consistent with your laboratory requirements.
Thermo Fisher Scientific offers powerful IVD microarray solution for postnatal clinical applications to obtain consistent, reliable, and high-quality results.
Our complete microarray IVD platform, the CytoScan Dx Cytogenetics Suite, includes CytoScan Dx arrays, manual target preparation options, fully kitted reagents, the GeneChip System 3000Dx instrument for array processing, and Chromosome Analysis Suite (ChAS Dx) Software for data interpretation and reporting. The platform supports laboratories to help maximize operational time.
The CytoScan Dx Assay was the first whole-genome in vitro diagnostic test available in the US market that is also IVDR 2017/746 compliant. It supports the identification of the underlying genetic cause of developmental delay, intellectual disability, congenital anomalies, or dysmorphic features in children. It is the recommended standard in chromosomal microarray analysis. The assays's remarkable performance provides:
Exceptional coverage across entries in OMIM database, RefSeq, ClinGen, and DECIPHER/DDD constitutional regions
The CytoScan Dx Assay is a qualitative assay intended for the postnatal detection of CNVs in genomic DNA obtained from peripheral whole blood in patients referred for chromosomal testing based on clinical presentation. The assay should be processed using the GeneChip System 3000Dx intrument and the data should be analyzed using Chromosome Analysis Suite Dx (ChAS Dx) Software. It is not intended to be used for standalone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or detection of or screening for acquired or somatic genetic aberrations.