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Roche Launches Next-Gen Viral Load Assay for CMV in Markets Accepting the CE Mark

Roche announced today the commercial availability of the cobas® CMV assay for use on the cobas® 6800/8800 Systems—further expanding the menu on the newest molecular diagnostic platforms from Roche. The new assay offers the exceptional performance that clinicians need when treating cytomegalovirus (CMV) infection in transplant recipients receiving anti-viral therapy.

"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," said Paul Brown, Head of Roche Molecular Diagnostics. "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."

This assay will be followed in the first quarter of 2015 by the cobas® HBV assay, completing the viral load monitoring portfolio for the cobas® 6800/8800 Systems. The cobas® 6800/8800 Systems, combined with the viral load assay portfolio, are designed to improve laboratory efficiencies while providing the rapid results needed to make informed treatment decisions.

The cobas® CMV assay and the cobas® 6800/8800 Systems are commercially available in markets that recognize CE-Mark and are not currently available in the United States.

About the cobas® 6800/8800 Systems

The cobas® 6800 and 8800 Systems are fully automated solutions designed for blood donor screening, viral load monitoring, women's health and microbiology testing. They are available in medium and high throughput models, respectively. Based on the Nobel-prize winning PCR technology, the systems are designed to deliver increased automation and throughput with shorter time to results, providing users with greater testing flexibility to increase overall workflow efficiencies.
The systems provide up to 96 results in less than 3.5 hours, and a total of 384 results for the cobas® 6800 System and 960 results for the cobas® 8800 System in an 8 hours shift.* Both systems allow for mixed batching, making it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas® 6800) and four hours (cobas® 8800) of "work-away" time* with minimal user interaction.

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