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Roche Gets CE Mark for New Molecular Blood Screening Systems

NEW YORK (GenomeWeb) — Roche said today that it has received CE marking for the cobas 6800/8800 automated molecular testing systems for blood and plasma donor screening.

The systems are now commercially available in all markets accepting the CE mark in Europe, Latin America, Middle East, Africa, and Asia.

Each system provides results for the first 96 tests in less than 3.5 hours, with the cobas 6800 delivering up to 384 results in an eight-hour shift, and the cobas 8800 generating up to 960 results in the same amount of time, Roche said.

Both systems can also simultaneously process multiple assays and are designed to enable up to eight hours (cobas 6800) and four hours (cobas 8800) of "walk-away" time with minimal user interaction, the company added.

The new portfolio includes the cobas 6800 and 8800, the cobas p 680 instrument to help create donor sample pools, and three next-generation real-time PCR assays for donor screening: cobas MPX, cobas WNV, and cobas HEV.

Cobas MPX is a multiplex test covering five critical viral targets: HIV-1 Group M, HIV-1 Group O, HIV-2, and hepatitis C and B viruses from a single sample. Meantime, cobas WNV tests for West Nile virus, and is highly sensitive for WNV lineages one and two; while cobas HEV tests for hepatitis E virus and provides broad coverage of all four major HEV genotypes, Roche said.

"The integrated and fully automated design of the new cobas 6800/8800 systems will allow labs to generate a high volume of results faster, with fewer manual steps, thus improving laboratory operations," Harry Bos, director of diagnostics for Dutch firm Sanquin Blood Supply, said in a statement. "These systems will help ensure a safe blood supply as the dynamics of the blood screening industry continue to rapidly change."