GenetiSure Dx Postnatal Assay
IVD
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.
INTENDED USE: The 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, board certified in clinical cytogenetics or molecular genetics. The assay is intended to be used on the SureScan Dx Microarray Scanner 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. 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 generic evaluation, and counseling, as appropriate. Interpretation of assay results is intended to be performed only by healthcare professionals, board certified in clinical cytogenetics or molecular genetics.
INTENDED USE: The 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, board certified in clinical cytogenetics or molecular genetics. The assay is intended to be used on the SureScan Dx Microarray Scanner 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. 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 generic evaluation, and counseling, as appropriate. Interpretation of assay results is intended to be performed only by healthcare professionals, board certified in clinical cytogenetics or molecular genetics.
For In Vitro Diagnostic Use.
Product Details
Features
- A complete workflow, from DNA to result
- 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
- Labeling, Hybridization and washing reagents are validated for diagnostic and optimized for use with GenetiSure Dx Array
- Dedicated reagents allow streamlined sample processing
- Only 500 ng of genomic DNA are required for testing, extracted from 200 μl of whole blood.
- 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.
- CytoDx software has been designed specifically for use with the GenetiSure Dx Postnatal Assay. The software addresses the needs of cytogeneticists for analysis and triage of their data
How It Works
Featured References
- Product Description References
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