FDA Authorizes Marketing Of The First Genetic Test To Aid Diagnosis Of Fragile X Syndrome

On February 21, 2020, the U.S. Food and Drug Administration (FDA) approved marketing of the first genetic test to aid in the diagnosis of Fragile X Syndrome (FXS). The FDA granted marketing authorization of the AmplideX Fragile X Dx and Carrier Screen Kit to Asuragen Inc. FXS is the most common, known cause of inherited intellectual/developmental disability (I/DD).

The test is intended as an aid in diagnosing FXS and is to be used along with the evaluation of an individual’s family history as well as clinical signs and symptoms of FXS. Additionally, this test is intended . . .