Asuragen introduces CE-mark approved AmplideX FMR1 PCR Kit

Asuragen, Inc. announced that they have achieved CE-marking and commercial launch in Europe of the AmplideX™ FMR1 PCR Kit for the detection of CGG repeats in the fragile X mental retardation (FMR1) gene. The AmplideX FMR1 PCR Kit is widely available through Asuragen's recently established network of distributors 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. These assay capabilities reduce the need for Southern blot testing to 2% or less of all samples.

According to Dr. Sara Seneca from the University of Brussels, Belgium, "This new technology has distinct advantages over existing methodologies and was easy to adopt for routine use in our clinical lab." Dr. David Barton from the National Centre for Medical Genetics in Dublin, Ireland, also commented that "We have gained substantial efficiencies since adopting the AmplideX Kit for our Fragile X testing."

"As we expand our molecular diagnostic portfolio for oncology and genetics with the launch of our proprietary CE-marked AmplideX FMR1 PCR Kit, we have put in place an experienced and effective network of European distributors already dominant in the molecular diagnostic testing arena," said President, Rollie Carlson Ph.D. "Our distribution partners will also serve a critical role in accelerating clinical validation and CE-marking of our portfolio of molecular diagnostic products."