Asuragen’s AmplideX Fragile X Dx and Carrier Screen Kit Receives the US FDA’s Approval for Detecting Fragile X Syndrome (FXS)

Shots:

• The test is targeted for diagnosing FXS in adults who are carriers of genetic alterations in the gene associated with FXS, called the FMR1 gene
• The US FDA reviewed the test through the de novo classification process and evaluated the data from specimens collected at three clinical sites to assess the accuracy of the test and further resulted in >95% diagnostic accuracy of the test
• The AmplideX Fragile X Dx and Carrier Screen Kit  utilizes the blood specimens of patients for measuring the number of repeats of the CGG segment in the FMR1 gene and the test can further determine whether a patient has a number of CGG repeats that is considered either normal, intermediate, premutation or full mutation

Click here to read full press release/ article | Ref: The US FDA | Image: Pharma