FDA authorized marketing of first genetic test to aid in diagnosis of Fragile X Syndrome

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On Feb. 21, 2020, the U.S. Food and Drug Administration (FDA) authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS) to Asuragen for the most common known cause of inherited developmental delay and intellectual disability.

The test is intended as an aid in diagnosing FXS and is to be used along with the evaluation of a patient’s family history and clinical signs and symptoms of FXS.

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Source: U.S. Food and Drug Administration
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