This article has been updated from a previous version to correct the names of the CE platforms used to run Asuragen's assay.
NEW YORK – The US Food and Drug Administration late on Friday authorized marketing of Asuragen’s AmplideX Fragile X Dx and Carrier Screen Kit, the first genetic test for fragile X syndrome (FXS).
The assay is intended to aid in diagnosing FXS and is to be used alongside the evaluation of a patient’s family history and clinical signs and symptoms, FDA said.
The test is also intended for use in