Roche gets FDA emergency use authorisation for LightMix Zika rRT-PCR Test

Roche has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its LightMix Zika rRT-PCR Test.

The test, which is manufactured by TIB MOLBIOL and exclusively distributed by Roche, detects Zika viral RNA in ethylenediaminetetraacetic acid (EDTA) plasma or serum samples using Roche's LightCycler 480 Instrument II, or cobas z 480 Analyzer.

The test is applicable to patients fulfilling CDC Zika virus clinical and CDC Zika virus epidemiological criteria.

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."

The fully automated process is performed over a period of 2.5 hours, starting with sample preperation, to issuing the results for up to 96 samples.

The Zika virus is primarily transmitted by Aedes mosquitoes, triggering symptoms such as mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise, or headache.

Infection of a pregnant woman can cause the fetus to develop microcephaly, which is an abnormal smallness of the head, causing incomplete brain development.

Roche is also developing the cobas Zika Test which will be used with the cobas 6800/8800 Systems.

Sign up for our daily news round-up!

Give your business an edge with our leading industry insights.

Sign up