The GenetiSure Dx Postnatal Assay uses Agilent's proprietary aCGH for copy-number and LOH data, enabling cytogeneticists to accurately detect genetic anomalies associated with developmental delay, intellectual disability, congenital anomalies, and dysmorphic features in children and adults. The GenetiSure Dx Postnatal solution includes all components required to process your microarray samples and perform data analysis.
GenetiSure Dx Postnatal Array
CGH + SNP microarray designed and validated for postnatal samples
Increased resolution in targeted genomic regions of known dose-sensitivity and significant clinical interest
Whole genome CN and LOH in a single assay
High fidelity 60-mer oligo based on Agilent OLS technology
Labeling, Hybridization and washing reagents are validated for diagnostic and optimized for use with GenetiSure Dx Array
Only 500 ng of genomic DNA are required for testing, extracted from 200 μl of whole blood.
The accuracy of GenetiSure Dx Postnatal Assay results is not affected by increased levels of blood contaminates or storage for up to 7 days
Data Generation & Analysis
The SureScan Dx Microarray Scanner is the foundation of our GenetiSure Dx Postnatal Assay that offers outstanding sensitivity and resolution, delivering flexibility to analyze genomics and cytogenetics microarrays.
INTENDED USE: GenetiSure Dx Postnatal Assay is a qualitative assay intended for the postnatal detection of copy-number variations (CNV) and copy-neutral loss of heterozygosity (cnLOH) in genomic DNA obtained from peripheral whole blood in patients referred for chromosomal testing based on clinical presentation. GenetiSure Dx Postnatal Assay is intended for the detection of CNVs and cnLOH associated with developmental delay, intellectual disability, congenital anomalies or dysmorphic features. Assay results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, parental evaluation, clinical genetic evaluation and counseling, as appropriate. Interpretation of assay results is intended to be performed only by healthcare professionals who are board-certified in clinical cytogenetics or molecular genetics.
The assay is intended to be used on the SureScan Dx Microarray Scanner System and analyzed by CytoDx Software.
WARNING: This device is not intended to be used for standalone or diagnostic purposes, pre-implantation or prenatal testing or screening, population screening or the detection of, or screening for, acquired or somatic genetic aberrations.
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