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Roche's HIV and HCV MDx Get CE Mark

NEW YORK (GenomeWeb) – Roche today said that its Cobas HIV-1 and HCV next-generation viral load monitoring assays have received CE marking.

The Cobas HIV-1 assay simultaneously amplifies and detects two separate regions of the HIV-1 genome to quantify the amount of viral RNA in the patient's blood. The Cobas HCV assay employs the firm's dual-probe approach to detect hepatitis C RNA. Both assays are available for use on the Cobas 6800 and 8800 systems.

The two molecular diagnostic systems are fully automated platforms for blood donor screening, viral load monitoring, women's health, and microbiology testing. Roche said in a statement that the viral load portfolio on the 6800 and 8800 systems "will provide laboratories with improved productivity and the ability to deliver results for rapid clinical decisions."

Roche first unveiled the Cobas platforms in May, 2013 and received the CE mark for them in September, 2014.

Roche also announced today that the Cobas HIV-1 and HCV assays are commercially available in geographies that recognize CE marking. The assays are not currently available in theUS.

In a statement, the firm said it will launch Cobas cytomegalovirus and Cobas hepatitis B assays in the coming months. 

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