FDA Approves Zika Virus Diagnostic for Emergency Use

Source: Regulatory Affairs Professionals Society (RADS)

Mar 08, 2016

The U.S. Food and Drug Administration (FDA) last week approved the first diagnostic to detect the Zika virus under its emergency use authorization pathway, reports the Regulatory Affairs Professionals Society (RADS). This allows the FDA to authorize unapproved products during a public health emergency.

There are currently no other approved diagnostics available to detect Zika, a mosquito-borne virus that has rapidly spread across much of Latin America and the Caribbean.

The test, called the Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay, was developed by the Centers for Disease Control and Prevention and is intended to detect the presence of anti-Zika antibodies in a patient's blood or cerebrospinal fluid.

To learn more about the EUA diagnostic approval and the spread of the Zika virus, read the full article from RADS.