Asuragen has secured the CE Mark for its diagnostic kit for spinal muscular atrophy (SMA).
The kit, called AmplideX SMA Plus, identifies asymptomatic carriers who risk passing the disease to their children, the company said. It analyzes two genes involved in the disease, SMN1 and SMN2 (a lack of functional copies of these genes is associated with SMA) and detects genetic variants linked to overall prognosis.
The kit consists of all the laboratory materials needed to run the test and is used with Asuragen's AmplideX Reporter software and can also be used on the Applied Biosystems family of genetic analyzers, the company said. It can be completed and results returned in four hours, according to Asuragen.