The FDA granted a marketing clearance to Asuragen for its Fragile X Syndrome (FXS) diagnostic kit, the first test for the rare genetic condition.
The agency cleared the AmplideX Fragile X Dx and carrier screen kit for use alongside evaluations of patient family history, clinical signs and symptoms of FXS.
The genetic condition impacts approximately one in 4,000 males and one in 8,000 females and is associated with learning disabilities, delays in development, intellectual disabilities, autism and social/behavioral issues. The test is cleared for detecting genetic alterations in adults in the gene associated with the condition, the FMR1 gene.
The test can also help diagnose disorders associated with FXS, including tremor/ataxia syndrome and primary ovarian insufficiency, the FDA said.