Asuragen, Inc. products

The AmplideX^® Fragile X Dx & Carrier Screen Kit is an in vitro diagnostic device that uses polymerase chain reaction (PCR) and capillary electrophoresis to detect and identify the number of cytosine-guanine-guanine (CGG) repeats in the fragile X mental retardation-1 (FMR1) gene using genomic DNA isolated from peripheral whole blood specimens. It is solely intended as an aid in the post-natal diagnosis of fragile X syndrome, and fragile X-associated disorders [i.e., fragile X-associated tremor/ataxia syndrome (FXTAS) or fragile X-associated primary ovarian insufficiency (FXPOI)], and for carrier testing in adults of reproductive age. Assay results are solely intended to be interpreted by healthcare professionals who are board certified in molecular genetics and to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice.

The AmplideX mPCR FMR1 Kit employs an innovative PCR-only approach for the detection of methylation status in the FMR1 gene. These reagents determine the extent of methylation of each individual allele in both male and female samples, and thus eliminate the need to run tedious and time consuming Southern blots.

AmplideX PCR/CE FMR1 Reagents* are market-leading research tools for the detection of CGG repeats in the fragile X mental retardation (FMR1) gene. These reagents provide a PCR-only approach based on Triplet Repeat Primed PCR (TP-PCR) design to reliably amplify and detect all alleles including Full Mutations.