Policy News

FDA Approves First Commercial Zika Test

Published: Wednesday, 30 November -0001 00:00
Written by STEPS
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The FDA has granted emergency authorization to Quest Diagnostics to sell a Zika virus test. This is the first commercially developed test that diagnoses the Zika virus. Quest Diagnostics planned to make the tests available to doctors, which expands their availability from the Center of Disease Control and Prevention laboratories. Infection with the Zika virus can present no symptoms, so the test will allow people who live in or have traveled to an area with Zika virus transmission to know if they are infected. The Emergency Use Authorization (EUA) allows the use of certain medical products after an emergency has been declared by the Secretary of Health and Human Services (HHS). Due to Zika’s significant potential for a public health emergency, the Secretary of HHS declared that the emergency use of in-vitro diagnostic tests for Zika is justified. See: http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMIssues/ucm485199.htm#eua.