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 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 travelers, 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.
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.
As Zika cases caused by local Aedes aegypti mosquitoes in Florida
mount and travelers from elsewhere continue to arrive with the
disease, the FDA last week recommend universal testing of donated
blood across the United States.
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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 centers including in Puerto Rico, where about 1 percent
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.
(Reporting by Joshua Franklin and John Miller; Editing by Subhranshu
Sahu and Susan Thomas)
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