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The FDA Has Issued Emergency Authorization for Roche’s Zika Test

August 29, 2016, 10:18 AM UTC
The Food and Drug Administration
UNITED STATES - NOVEMBER 9 - The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906. (Photo By Al Drago/CQ Roll Call)
Al Drago/CQ Roll Call

The U.S. Food and Drug Administration on Monday issued emergency authorization for a Zika diagnostics test from Swiss drugmaker Roche, skirting normal approval channels as the regulator moves to fight the disease’s spread.

Zika virus, detected in Brazil and elsewhere last year before spreading to the Americas, is associated with microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.

Through last week, the United States reported 2,517 Zika cases, 29 of which were likely acquired locally in Florida through mosquito bites and the rest brought in by travellers, the U.S. Centers for Disease Control and Prevention (CDC) said.

Some 9,000 additional cases have been reported in U.S. territories, including Puerto Rico.

See also: Zika Spreads to Miami Beach, U.S. Expands Travel Warning

With FDA approval, Roche’s test now can be used to screen patients exhibiting Zika symptoms that meet CDC criteria, including fever, rash, joint pain and red eyes. Samples will be sent for analysis to specially-certified U.S. laboratories with the appropriate equipment, a Roche spokesman said.

“The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus,” said Uwe Oberlaender, the head of molecular diagnostics at Basel-based Roche.

The FDA issues such Emergency Use Authorization during public health emergencies, to quickly deploy unapproved medical products for as long as they are needed.

See also: Singapore Clears Drains and Sprays Residences in New Battle Against Zika

As Zika cases caused by local Aedes aegypti mosquitoes in Florida mount and travellers from elsewhere continue to arrive with the disease, the FDA last week recommend universal testing of donated blood across the United States.

In March, Roche won separate investigational approval from the FDA for its Cobas 6800/8800 testing system to be used to test blood at U.S. blood centres including in Puerto Rico, where about 1% of donated blood has so far tested positive for the virus.

In Brazil, Zika virus has been linked to more than 1,800 cases of microcephaly, and U.S. officials expect as many as 270 cases in Puerto Rico.