Thermo Fisher Scientific CytoScan Dx Assay Training Kits

Thermo Fisher Scientific CytoScan Dx Assay Training Kits

The Applied Biosystems CytoScan Dx Assay is a US FDA-cleared and EU IVDR-compliant advanced microarray diagnostic test for identifying underlying genetic causes of developmental delay, intellectual disability, congenital anomalies, or dysmorphic features in children.

This CytoScan Dx Assay Training Kit includes arrays and reagents sufficient for 24 reactions, plus training materials for the complete CytoScan Dx cytogenetics solution.

Key Benefits

• Advanced diagnostic reliability — FDA-cleared and IVDR-compliant postnatal blood test aiding in diagnosis of developmental delay, intellectual disabilities, congenital anomalies, or dysmorphic features
• Whole-genome analysis — Detects numerous chromosomal variations of various types, sizes, and genomic locations with higher resolution than karyotyping and broader coverage than conventional FISH
• Future-ready design — Incorporates 2.69 million functional markers across the genome, ensuring representation of most genes
• Dual probe content — CN and SNP probes enable detection of allelic imbalances and identification of LOH/AOH associated with uniparental disomy or consanguinity
• Exceptional performance — High specificity, sensitivity, accuracy, and resolution across the genome
• Streamlined data analysis — Chromosome Analysis Suite Dx (ChAS Dx) Software offers intuitive workflows, ISCN array nomenclature, and database links for efficient analysis
• Improved diagnostic yield — 12.5% higher diagnostic yield compared to G-banded karyotyping due to whole-genome coverage

Recommended Use

Chromosomal microarray analysis (CMA) is recommended as a first-line test for diagnostic evaluation of intellectual disability (ID) by multiple medical societies, including:

• American Academy of Neurology (AAN)
• Child Neurology Society (CNS)
• American College of Medical Genetics (ACMG)
• European Society of Human Genetics (ESHG)

CMA is preferred over traditional karyotyping and FISH due to:

• Greater sensitivity
• Higher resolution
• Genome-wide capability
• Increased diagnostic yield

Customer Training and Support

Customer training is required to implement the CytoScan Dx Assay. Various training options are available based on experience level.
For details, please contact: techsupport@thermofisher.com

Intended Use

The CytoScan Dx Assay is a qualitative assay for postnatal detection of chromosomal copy number variants (CNVs) in genomic DNA from peripheral whole blood.
It is indicated for detecting CNVs associated with:

• Developmental delay and/or intellectual disability (DD/ID)
• Congenital anomalies
• Dysmorphic features

Results should be interpreted by board-certified healthcare professionals in clinical cytogenetics or molecular genetics, in conjunction with other clinical findings and confirmatory methods.

The complete CytoScan Dx Suite includes:

• CytoScan Dx Array
• Reagent Kit
• Applied Biosystems GeneChip System 3000 Dx platform
• ChAS Dx Software

Specifications

제품 이미지

(이미지 없음 — OCR 텍스트 통합 완료)