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FDA approves Roche’s automated blood screening assay for use on cobas 6800/8800 systems

MDBR Staff Writer Published 24 October 2016

Roche has secured approval from the US Food and Drug Administration (FDA) for its fully automated blood screening assay for use on the cobas 6800 and 8800 systems.

The donor screening laboratories can use the cobas MPX test to apply an advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the US.

The cobas MPX is a nucleic acid test that enables to detect HIV, HBV and HCV in human blood plasma and serum.  

It is a real-time PCR multiplex test that will allow to detect five critical viral targets, including HIV-1 Group M, HIV-1 Group O, HIV-2, HBV and HCV, from a single sample.

According to the company, the assay features a dual-target approach with amplification of separate regions of HIV-1, and dual probes for HCV. 

The cobas 6800 and 8800 systems are fully integrated and automated solutions, which can be used in the areas of donor screening, viral load monitoring, women’s health and microbiology

The systems, which will offer up to 96 results in less than 3.5 hours, will help labs to carry out three tests in the same run with no pre-sorting required.

Roche Molecular Diagnostics head Uwe Oberlaender said: “This approval reinforces our strong presence in donor screening, and underscores our ability to provide proven, robust technology for the testing of donated blood and blood products.

“We will continue to partner with donor screening laboratories worldwide demonstrating our joint commitment to patient safety.”

In August, Roche secured FDA emergency use authorization (EUA) status for its LightMix Zika rRT-PCR test.

Produced by TIB MOLBIOL and exclusively marketed by Roche, the LightMix is an assay to qualitatively detect Zika viral RNA in combination with a full process RNA control that monitors all steps from extraction to PCR result.


Image: The administration and R&D buildings, Roche Diagnostics Ltd, Rotkreuz. Photo: courtesy of F. Hoffmann-La Roche Ltd.