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Whole-genome analysis with a US FDA–cleared and EU IVDR–compliant assay

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.

To learn more about the complete IVDR-compliant CytoScan cytogenetics solution, please fill out your information below:

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Detect more chromosomal
aberrations in a single assay

See the brochure ›

CytoScan Dx, a complete microarray
solution is now EU IVDR–compliant

Read the FDA press release ›

Professional associations' recommendations
on the use of CMA

Read the AAN guidelines ›
Read the ICCG/ISCA statement ›

For In Vitro Diagnostic Use