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Analytik Jena Gets CE-IVD Mark for HDV Assay

NEW YORK (GenomeWeb) – Analytik Jena has received CE-IVD mark for a molecular diagnostic test for hepatitis delta virus, or HDV, the Jena, Germany-based company announced today.

Called the RoboGene HDV RNA Quantification Kit 2.0, the real-time qPCR-based detection and quantification assay adds to a range of molecular diagnostic products for hepatitis B and C viruses offered by the company, and will be the first commercial molecular assay for HDV on the market, Analytik Jena said.

Hepatitis delta is a deficient virus that requires coexisting HBV virus in order to replicate, according the World Health Organization.

Analytik Jena will also offer the HDV test in a kit that includes its RoboGene HBV DNA Quantification Kit 2.0 assay and reagents for extraction and detection.

That combination kit was validated with a dual chemistry RNA/DNA purification kit developed by Analytik Jena subsidiary AJ Innuscreen, and the firm is working on adapting the kit to its current automation platforms.