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Asuragen Myotonic Dystrophy 1 Dx Kit Receives CE Mark

NEW YORK (GenomeWeb) — Asuragen said today that it has received CE marking for its AmplideX DM1 Dx kit for use in the diagnosis of myotonic dystrophy type I (DM1).

DM1, also known as Steinert's disease, is an inherited form of muscular dystrophy characterized by a repeat expansion of 50 CTG trinucleotides or greater in the DMPK gene. According to Asuragen, disease severity positively correlated to the number of repeats, which can extend beyond 1,000.  

The newly launched kit uses a PCR-based workflow to detect and size repeat expansions up to 200 repeats for as little as 20 nanograms of DNA within an eight-hour laboratory shift. For expansions up to 1,000 repeats, the kit includes an optional agarose gel electrophoresis workflow to further estimate their size without the need for Southern blot.

Asuragen noted that the AmplideX DM1 Dx kit is designed for use on Applied Biosystems' suite of Genetic Analyzers. Earlier this year, the Austin-based company introduced a research-use-only kit for analyzing DMPK repeat expansions.