Seamless CGH Diagnostic Testing
GenetiSure Dx Postnatal Assay
Informed decisions start with a complete microarray platform for postnatal analysis
GenetiSure Dx Postnatal Assay
A complete workflow, from DNA to result
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. The GenetiSure Dx Postnatal solution includes all components required to process your microarray samples and perform data analysis.
Clinical Performances
Results you can trust
The Genetisure Dx Postnatal assay has been validated with a Clinical study involving different partner laboratories, and including more than 900 samples.
During the study we obtained a diagnostic yield of 15% and 92.9% agreement with the reference diagnosis for Copy Number.
Variation studies performed on the Assay
A complete workflow, from DNA to result
Assay Selection
GenetiSure Dx
Postnatal Array
Sample Processing
Dx Reagents
Data Generation & Analysis
SureScan Dx
Data Interpretation
Alissa Clinical Informatics
For customers who have purchased the GenetiSure Dx Postnatal Assay: Access the User Portal
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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For In Vitro Diagnostic Use.