FDA has approved the Affymetrix CytoScan Dx Assay manufactured by Affymetrix Inc. in Santa Clara, California, to detect chromosomal variations that may be responsible for a child’s developmental delay or intellectual disability. This can be determined by taking a blood sample where a test can then analyze the entire genome at one time and detect large and small chromosomal changes.
According to NIH and the American Academy of Pediatrics, two to three percent of children in the U.S. have some form of intellectual disability. Many intellectual and developmental disabilities such as Down syndrome and DiGeorge syndrome are associated with chromosomal variations.
“This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing healthcare providers and parents to intervene with appropriate care and support for the child,” said Alberto Gutierrez, PhD, Director of the Office of In-Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
FDA reviewed the low-moderate-risk medical device and found that the device could analyze a patient’s entire genome and adequately detect chromosome variations in regions of the genome associated with intellectual and developmental disabilities.
Additionally, FDA’s review included a study that compared the performance of the device to tests that are commonly used for detecting chromosomal variations associated with a developmental delay or intellectual disability. A comparison of test results from 90 blood specimens showed that the device was improved over commonly used tests.
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 for screening for acquired or genetic aberrations occurring after birth.