Asuragen has launched CE marked AmplideX FMR1 PCR Kit for the detection of CGG repeats in the fragile X mental retardation (FMR1) gene in Europe.

The AmplideX FMR1 PCR Kit is used as an aid in the diagnosis of fragile X syndrome and associated disorders, such as fragile X-associated primary ovarian insufficiency (FXPOI) and fragile X-associated tremor/ataxia syndrome (FXTAS).

The kit provides a high throughput PCR and CE analysis workflow that can accurately resolve sample zygosity and reproducibly detect the full range of full mutation alleles in a single reaction.

Asuragen said the assay capabilities reduce the need for Southern blot testing to 2% or less of all samples.

Asuragen president Rollie Carlson said as they expand molecular diagnostic portfolio for oncology and genetics with the launch of proprietary CE-marked AmplideX FMR1 PCR Kit, they have put in place an experienced and effective network of European distributors already dominant in the molecular diagnostic testing arena.

"Our distribution partners will also serve a critical role in accelerating clinical validation and CE-marking of our portfolio of molecular diagnostic products," Carlson said.