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Genedrive Human Genotyping Test Gets CE-IVD Marking

NEW YORK (GenomeWeb) — 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."

He added that Genedrive is currently looking to partner with pharmaceutical companies and contract research organizations to help develop SNP assays for clinical applications. 

In early 2015, India issued a three-year import license for Genedrive's molecular tuberculosis and antibiotic resistance test.