WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration said On Friday that it authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child's developmental delay or intellectual disability. Based on a blood sample, the test can analyze the entire genome at one time and detect large and small chromosomal changes. Affymetrix CytoScan Dx Assay is manufactured by Affymetrix Inc. (AFFX).
According to the National Institutes of Health and the American Academy of Pediatrics, two to three percent of children in the United States have some form of intellectual disability. Many intellectual and developmental disabilities, such as Down syndrome and DiGeorge syndrome, are associated with chromosomal variations.
The FDA advised that the device should not be used for stand-alone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for acquired or genetic aberrations occurring after birth, such as cancer.
The FDA also said that the test results should only be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, evaluation of parental samples, clinical genetic evaluation, and counseling as appropriate.
AFFX closed Friday's regular trading at $9.26, down $0.22 or 2.32%. However, in after-hours, the share gained $0.22 or 2.38%.
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