Find Products

Help Us, Help You

We genuinely believe in what we do and want to be the best life sciences supply partner. Any information to help our journey is very welcome. Please take a few minutes to help us improve and make your future experiences better:

Revolutionary testing kit for Myotonic Dystrophy receives CE-IVD certification

12 December 2018

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.

Back to news

Find Products

We work with a range of suppliers with novel and innovative products sourced from our global partners.

Find Products

Browser Warning

VHBio is not supported on Internet Explorer and will not provide you with the best experience. Please consider switching to a compatible browser such as Microsoft Edge, Google Chrome or Firefox.