New diagnostic test for Zika approved temporarily by FDA
SAN JUAN – The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization for a Zika virus diagnostic test (the LightMix Zika rRT-PCR), manufactured by Swiss pharmaceutical giant Roche Laboratories, that has yet to receive official clearance. The emergency authorization would allow certified clinical labs to use it in the hunt for the mosquito-borne virus.
“The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus,” Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a written statement.
“The end-to-end automated process from sample preparation to results for up to 96 samples can be performed in just 2.5 hours,” Oberlaender added.
The company said its test would allow labs to process a greater number of samples and speed up the time it takes to determine if someone is infected with Zika, which causes only mild symptoms, such as fever and a rash, in only 20 percent of those infected. The remaining 80 percent, even though infected, would not show symptoms from the disease.
The announcement comes amid growing concern in the United States about Zika, which can cause a severe birth defect known as microcephaly, in which babies develop abnormally small skulls and brains. Nevertheless, there is no scientific evidence available to support a link between the Zika virus and microcephaly in newborn children. However, there is evidence of some neurological and sensory damage in newborn children of mothers infected by the virus at some stage during their pregnancies.
More than 2,500 people in the United States have been diagnosed with Zika, along with more than 14,000 in Puerto Rico and other U.S. territories, according to the U.S. Centers for Disease Control and Prevention.
The Zika virus has been detected in 58 countries, particularly in Brazil, where the latest global outbreak erupted last year.