Asuragen De Novo Granted for Fragile X Test

FDA has granted de novo marketing authorization to Asuragen’s AmplideX Fragile X Dx and Carrier Screen Kit for detecting a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability. The test is intended as an aid in diagnosing FXS in conjunction with a patient’s family history and disease clinical signs and symptoms, FDA says. Additionally, the device is intended for use in adults who may be carriers of genetic alterations in the gene associated with FXS, called the FMR1 gene.

Under the de novo process, FDA evaluated data from specimens collected at three clinical sites to assess the test’s accuracy. “The data demonstrated that the diagnostic accuracy of the test is greater than 95%,” the agency says. It also designated special control that test developers must meet for similar FXS tests, including labeling and performance testing requirements.