With concerns over a continued Zika outbreak growing, the Food and Drug Administration has given Roche Holdings emergency approval to use one of its Zika blood testing kits.
The approval, which lasts as long as the emergency is ongoing, will allow for testing of the virus through Roche's LightMix Zika rRT-PCR test, which has not been approved by the FDA yet.
The test uses the company's LightCycler 480 Instrument II or cobas z 480 Analyzer to search for Zika. The systems, found in specialist laboratories, can help detect the virus which can be more easily be found in blood samples. The disease can also be found in urine. On its site Roche says the cobas z 480 can process 384 samples per day.
The Roche emergency approval is the latest in the FDA's search to more quickly identify and contain the virus. The agency had previously approved nine other systems for detecting Zika since February under similar emergency use authorizations. It approved two systems that help detect the disease, one from InBios International and another from Luminex Corporation, earlier this month.
On Friday the FDA announced that all blood donations in the U.S. needed to be scanned for Zika, which over the last few weeks has spread into Florida and Puerto Rico.
Since officials revealed its presence in the state earlier this month over 40 people in the Miami-Dade and Palm Beach counties in Florida have been diagnosed with the virus.
The FDA updated its guidance due to the potential serious health consequences of Zika to pregnant women and children born to women exposed to the virus during pregnancy. The Zika virus is transmitted primarily by the Aedes mosquito but can also be spread by sexual contact. Although most people infected with the virus never develop symptoms, an infection during pregnancy can cause serious birth d
Source :http://www.usatoday.com/
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