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Asuragen Receives CE Mark for Spinal Muscular Atrophy Assay

NEW YORK – Molecular diagnostic firm Asuragen said Tuesday that its in vitro diagnostic test for spinal muscular atrophy received CE marking. 

The AmplideX SMA Plus Kit can help diagnose SMA and determine if asymptomatic carriers could pass the neuromuscular disease on to their children, the company said in a statement. The test quantifies the copy number of SMN1 and SMN2, the genes associated with the disease, and detects additional variants that can impact "silent carrier" status and overall disease prognosis.

SMA is associated with a loss of functional copies of the SMN1 gene and severity is related to the number of copies of SMN2. Gene duplication variants in the SMN1 gene may help identify asymptomatic carriers of the disease, and a specific SMN2 disease modifier variant can signal a milder disease phenotype, the company added.

The PCR test requires less than an hour of hands-on time and takes four hours total to run. It's optimized for use on Thermo Fisher Scientific's Applied Biosystems Genetic Analyzers.