Roche files with FDA for cobas 4800 CT/NG test clearance

The CT/NG test runs on the fully automated cobas 4800 platform which was recently introduced in the US concurrent with the approval of Roche‘s HPV test.

It utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of CT/NG in a single analysis.

The test, CE marked in 2009, is currently available in numerous countries around the world.

Roche Molecular Diagnostics head Paul Brown said with this test Roche will expand the menu on the recently approved cobas 4800 platform currently in use in the US for HPV testing and so continue to improve the workflow for laboratories.

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