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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