Subscribe to PCR Genedrive Human Genotyping Test Gets CE-IVD Marking

British molecular diagnostics firm Genedrive announced today that its Genedrive IL28B SNP human genotyping test has received CE-IVD certification, clearing it for sale in Europe.

According to Genedrive — formerly known as Epistem — the test is performed in less than an hour using a buccal cheek swab, and runs on the company’s hand-held real-time PCR instrument. Data supporting the test’s CE marking showed that it was 100 percent accurate in detecting inherited genetic polymorphisms in hepatitis C (HCV) patients compared to Roche's TaqMan PCR, the current gold standard.

"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," Genedrive CEO David Budd said in a statement. "While the treatment of HCV has evolved since we started the EU-sponsored IL28B program, the outcome clearly shows how our innovative technology can be put into practice in pharmacogenomics applications."