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Medical Devices / Submissions and Approvals

Asuragen’s DM1 Assay Gets CE Mark

Dec. 5, 2018
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Asuragen’s myotonic dystrophy type I (DM1) assay, the AmpliedeX DM1 Dx Kit, has earned the CE Mark.

The device helps in the diagnosis of DM1, also known as Steinert’s disease, an inherited form of muscular dystrophy.

The kit includes reagents to accurately measure every expansion of the disease using as little as 20 nanograms of DNA.

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