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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.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.