Posted by Michael Wonder on 22 Feb 2020
FDA authorises marketing of the first genetic test to aid in the diagnosis of Fragile X syndrome
21 February 2020 - The U.S. Food and Drug Administration today authorised marketing of the first test to detect a genetic condition known as Fragile X syndrome, the most common known cause of inherited developmental delay and intellectual disability.
The test is intended as an aid in diagnosing Fragile X syndrome (FXS) and is to be used along with the evaluation of a patient’s family history and clinical signs and symptoms of FXS.
Additionally, this test is intended for use in adults who may be carriers of genetic alterations in the gene associated with FXS, called the FMR1 gene.
