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FDA Issues Emergency Authorization For Roche Zika Test

The Roche Tower in Basel - Photo from Wikipedia

Swiss drug company Roche announced Monday that the US Food and Drug Administration had greenlit an emergency authorization to employ its yet-unapproved diagnostic test for Zika virus detection, Reuters reports.

The FDA issued the Emergency Use Authorization (EUA) for the pharmaceutical giant’s LightMix Zika rRT-PCR, which has yet to receive official clearance that will allow authorized laboratories to use it to detect the potentially damaging virus.

Uwe Oberlaender, the head of molecular diagnostics at Roche in Basel, says,

The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus.

The emergency measure comes in the wake of a perceived growing Zika threat in the United States. The Centers for Disease Control and Prevention reports that more than 2,500 Americans have been diagnosed with the virus and 9,000 more in Puerto Rico and US territories.

The mosquito-borne virus can cause severe birth defects, including microcephaly, in infected pregnant women. Zika has also been associated with Guillain-Barre syndrome, which leads to paralysis and other neurological problems.

Roche stated that the LightMix Zika test would enable labs to process a larger number of samples and would cut down on waiting time for diagnosis. Many infected patients show no symptoms, while others suffer mild signs such as fever and a rash.

The amount of time for the test to process “from sample preparation to results for up to 96 samples can be performed in just 2.5 hours,” Roche said.

The drugmaker emphasized that the test is only authorized for use “for the duration of the declaration that circumstances exist justifying the authorization.” The test will have to undergo official clearance and approval for widespread public use.

Roche is one of the world’s largest names in cancer drug manufacturing and is a leader in making new diagnostic tests. In March, the FDA approved one of the company’s blood tests for detecting Zika under an Investigational New Drug Application protocol that seeks to begin collecting and testing blood samples, according to Yahoo News.

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