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Chembio's Ebola test wins FDA approval for emergency use

Chembio Diagnostic Systems in Medford, seen Oct. 31,

Chembio Diagnostic Systems in Medford, seen Oct. 31, 2016. Photo Credit: Barry Sloan

Chembio Diagnostics Inc. has won approval from the federal Food and Drug Administration for emergency use of its Ebola test, officials said.

The Medford-based manufacturer of rapid tests for HIV, syphilis, Zika and other diseases said its blood test for Ebola is “authorized for presumptive detection in individuals with signs and symptoms.”

Ebola was first discovered in 1976 in the Congo and is often fatal. The illness is characterized by fever, fatigue, muscle pain, headache and sore throat. An outbreak in 2014-16 in West Africa was the worst in history, according to the World Health Organization.

“We believe [the test] will be a valuable tool to address the global threat posed by Ebola virus, including the ongoing outbreak in the Democratic Republic of the Congo,” Chembio CEO John J. Sperzel said last week. “We hope to receive support and funding as we pursue additional regulatory approvals for our rapid Ebola test.”

The FDA approval is for a limited time period.


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