The FDA has authorized for marketing the Affymetrix CytoScan Dx Assay, a diagnostic tool that can analyze an entire genome and detect large and small chromosomal changes based on a blood sample. Many developmental and intellectual disabilities are associated with chromosomal variations (eg, Down syndrome and DiGeorge syndrome). This assay may help in identifying possible causes of developmental delay or intellectual disability in children.

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The FDA reviewed the Affymetrix CytoScan Dx Assay through its de novo classification process for novel low-moderate-risk medical devices. The CytoScan Dx Assay is able to accurately detect numerous chromosomal variations of different types, sizes, and genome locations. When compared to other commonly used tests, such as karyotyping and FISH, the CytoScan Dx Assay demonstrated improved ability to detect chromosomal variations associated with developmental delay or intellectual disability.

The assay is not a stand-alone diagnostic device, and should only be used in conjunction with other clinical and diagnostic findings consistent with professional standards of practice. The results from the assay should be interpreted only by healthcare professionals who are board certified in clinical cytogenetics or molecular genetics.

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