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Roche's Cobas CMV Viral Load Assay Gets CE Mark

NEW YORK (GenomeWeb) – Roche today announced that its Cobas CMV viral load assay for human cytomegalovirus has received CE marking.

The real-time PCR-based assay, which runs on the Cobas 6800/8800 systems, meets the first World Health Organization International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques and, therefore, provides consistent and reliable results for monitoring the viral load in transplant patients receiving an anti-viral therapy, Roche said in a statement.

"The unparalleled performance and unmatched flexibility of the Cobas 6800/8800 systems allows laboratories to ensure rapid turn-around time for critical tests, like Cobas CMV, while still delivering routine viral load monitoring results," Paul Brown, head of Roche Molecular Diagnostics, said. "Cobas CMV is harmonized to the WHO standard to ensure that laboratories and clinicians can rely on this test, leading to increased quality of care and comparable results across different labs for patients infected with CMV."

Roche said that the HCV assay is the penultimate step in completing the viral load monitoring portfolio for the Cobas 6800/8800 systems and will be followed by the release of the Cobas HBV assay for hepatitis B in the first quarter of 2015.

The Cobas CMV assay and the 6800/8800 systems are commercially available in markets that recognize the CE mark and are not currently available in the US.

Roche recently announced that its Cobas HIV-1 and HCV assays running on the Cobas 6800/8800 systems also received CE marking. Roche currently offers a qPCR-based CMV assay, available for the Cobas p 630 instrument.