Genedrive PLC (LON:GDR) has received European regulatory sign-off for its rapid genotyping device for patients with hepatitis-c.
It has been awarded what’s called CE-IVD certification - that’s the official CE mark for an in-vitro diagnostic medical device.
This covers the IL28B platform, which performs a 50-minute test to determine which form of hepatitis-c a person has contracted.
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The handheld IL28B device, which uses a swab taken from inside the cheek, was 100% accurate in detecting inherited genetic polymorphisms when compared to the current 'gold-standard' laboratory test.
It is quicker and presumably cheaper than sending off samples for central analysis, which takes upwards of two weeks.
Genedrive said the CE approval “further validates” its platform.
Being able to understand people’s genetic make-up quickly and cheaply in this way has applications outside the treatment of hepatitis c.
Genotyping, as it is called, could provide an important tool to the drugs industry, allowing it understand just which patient populations will respond to certain treatments and which won’t.
“What we are looking for is for partners to develop additional assays on our Genedrive platform,” Genedrive chief executive David Budd told Proactive Investors.