The American Academy of Neurology (AAN), the American College of Medical Genetics (ACMG), and the International Collaboration for Clinical Genomics (ISCA/ICCG), among other professional associations, recommend chromosomal microarray analysis (CMA) as the first-line genetic test to aid in the diagnostic evaluation of developmental delay, intellectual disabilities, and congenital anomalies.
These guidelines for CMA to replace traditional karyotype and FISH as the first-line genetic testing are due to its greater sensitivity, higher resolution, genome-wide capability, and greater diagnostic yield.
The CytoScan Dx Assay is cleared by the US Food and Drug Administration (FDA) and compliant with the EU In Vitro Diagnostic Regulation (IVDR) 2017/746.
