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Roche Obtains CE Mark for Cobas HBV Viral Load Test

NEW YORK (GenomeWeb) – Roche today announced its Cobas HBV assay for hepatitis B viral load monitoring has received CE marking.

The assay is a real-time PCR test for HBV genotypes A through H designed for use on the Cobas 6800/8800 systems. The medium- and high-throughput PCR systems were unveiled in 2013, and allow for rapid, automated, mixed-batch processing.

The HBV assay adds to a portfolio of viral load monitoring tests populating these systems, including ones for cytomegalovirus, HIV-1, and hepatitis C virus.

The Cobas 6800/8800 CMV assay was CE marked in December of last year, followed by HIV-1 and HCV. Roche also got CE marks on a series of automated blood screening tests using the platforms. Two of those tests subsequently received an expanded claim for organ donation testing.

The 6800/8800 systems and assays are not currently available in the US, but are commercially available in markets that recognize CE mark.