Revolutionary testing kit for Myotonic Dystrophy receives CE-IVD certification

Published December 12, 2018 10:40 am by James Briggs

A kit designed to revolutionise how repeat expansions within the DMPK gene can be analysed has obtained CE marking and been cleared for use as an IVD device throughout Europe.

The AmplideX® DM1 Dx Kit simplifies the analysis of repeat expansions within the DMPK gene and is intended to aid in the diagnosis of Myotonic Dystrophy Type I (DM1).

The kit is developed by Asuragen with the aim of bringing this analysis within the reach of more laboratories, saving time and cost. It is available exclusively in the UK from VH Bio, and now carries CE-IVD certification, which indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive. (98/79/EC).

With this approval, the ground-breaking assay is now cleared for use as an aid in the diagnosis of the condition that affects one in 8,000 people.

As with all Amplidex products, the kit is designed to be simple and rapid, allowing streamlined testing that can accurately and reliably determine the number of CTG repeats from as little as 20ng DNA – without the need for Southern blot technology.

The kit has already proven popular among some of VH Bio’s valued UK customers.

“We have verified the [AmplideX DM1 Dx Kit] in our diagnostic laboratory and were delighted with the results,” said Nicola Williams, consultant clinical scientist of Queen Elizabeth University Hospital in Glasgow.

“This assay is easy to use from test setup to analysis and reporting of results. It was able to detect and resolve every expansion we investigated and provided accurate sizing of large pathogenic repeats.”

You can find out more about the background of DMPK testing, along with the importance of improving the accessibility of such tests to laboratories, on our launch blog post here.



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