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Roche Zika test secures FDA emergency use authorization

MDBR Staff Writer Published 30 August 2016

Roche has received emergency use authorization (EUA) status from the US Food and Drug Administration (FDA) for its LightMix Zika rRT-PCR test.

The test can now be used in patients who meet CDC Zika virus clinical criteria or CDC Zika virus epidemiological criteria.

By using Roche's LightCycler 480 instrument II or cobas z 480 analyzer, the LightMix will detect Zika virus in EDTA plasma or serum samples.

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.

Nucleic acid extraction is authorized to be carried with Roche's MagNA pure compact instrument. It will enable high-throughput automated extraction.

LightMix Zika rRT-PCR test will run on the LightCycler 480 Instrument II or cobas z 480 analyzer.

The company has also developed cobas Zika Test that run on the cobas 6800/8800 systems, in addition to the LightMix Zika rRT-PCR test.

Roche molecular diagnostics head Uwe Oberlaender said: "The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus.

"As a leader in diagnostics, Roche is committed to providing testing solutions for the world's most challenging healthcare emergencies.

“The FDA's granting of this EUA supports our commitment to help healthcare professionals who are working to combat this serious disease."


Image: Aedes aegypti is a mosquito that can spread Zika fever. Photo: courtesy of Muhammad Mahdi Karim.