Molecular diagnostics firm genedrive has secured CE-IVD certification for its rapid human genotyping test.
The approval for Genedrive IL28B SNP human genotyping test further validates the company's platform for rapid point of care human genotyping.
By using Genedrive hand-held real-time PCR instrument, the test can be carried out in around 50 minutes from a buccal cheek swab.
The company said tthe CE-IVD certification further validates Genedrive as a technology platform for pharmacogenomics.
Genedrive platform and its polymorphism genotyping capabilities making it suitable solution for on the spot stratification, while its low instrument cost, simple operation and connectivity options enable to deploy for large numbers of coordinated trial sites.
In August, the company announced that Genedrive IL28B human genotyping test will be used in the STOP-HCV-1 clinical trial being carried out by STOP-HCV.
STOP-HCV is a consortium that will use stratified medicine to optimise the treatment for patients with Hepatitis C Virus infection.
The study will evaluate the effectiveness of different treatment durations with Direct Acting Antiviral treatments on HCV Genotype 1 patients.
Genedrive CEO David Budd said: "We are now looking to partner with Pharma and Contract Research Organisations to support the development of SNP assays for clinical trials and clinical applications.
“Through our development of the IL28B test, we have defined a rapid pathway for the generation of a quick, accurate, and effective human genotyping tests that can be deployed at the point of need.”
“While the treatment of HCV has evolved since we started the EU sponsored IL28B programme, the outcome clearly shows how our innovative technology can be put into practice in pharmacogenomics applications."