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Regulatory Focus™ > News Articles > FDA Clears First Zika Diagnostic for Emergency Use

FDA Clears First Zika Diagnostic for Emergency Use

Posted 26 February 2016 | By Michael Mezher 

FDA Clears First Zika Diagnostic for Emergency Use

The US Food and Drug Administration (FDA) on Friday approved the first diagnostic to detect the Zika virus under its emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved products during a public health emergency.

The authorization is significant as 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 and is thought to be behind an increase in cases of microcephaly and Guillain-Barré Syndrome.

As of Friday morning, the World Health Organization says more than 50 countries and territories have reported local transmission of the Zika virus, and though a conclusive link between the Zika and microcephaly has not been demonstrated, scientists believe they'll have enough evidence to prove the link in the coming months.

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

According to a letter from FDA Commissioner Robert Califf, Secretary of Health and Human Services Sylvia Burwell declared that Zika poses "a significant potential for a public health emergency," clearing the way for FDA to issue an EUA.

The letter explains that FDA is issuing the EUA after concluding that the test "may be effective" at diagnosing the disease and because the test poses a low level of risk to patients.

Under the EUA, the test may be used for patients displaying Zika symptoms, patients who have recently traveled to a Zika-affected region, or for patients who meet "other epidemiologic criteria."

Due to the potential for false positives, FDA says that positive or ambiguous results must be further investigated by CDC or other labs to confirm the presence of anti-Zika IgM antibodies.

FDA says it is waiving both current good manufacturing practice (cGMP) and labeling requirements for the diagnostic while the EUA is active and has provided a list of conditions that CDC and authorized labs must follow, including provisions for monitoring and reporting test results.

The agency has previously issued EUAs for diagnostics and treatments for several diseases, including Ebola, enterovirus, H7N9 influenza, Middle East Respiratory Syndrome (MERS) and anthrax.

FDA Emergency Use Authorization


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