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Zika Diagnostic Gets FDA Emergency Use Authorization

ZIka VIrus DiagnosticsU.S. Food and Drug Administration (FDA) has given an Emergency Use Authorization (EUA) for a multiplex nucleic acid test designed to detect Zika virus RNA in potentially infected patients.

Designed by Luminex partner, GenArraytion, Inc., the xMAP® MultiFLEX™ Zika RNA Assay detects Zika viral RNA in serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen).

The Zika virus can be detected in blood and urine, and in July 2016, the Centers for Disease Control and Prevention updated its guidance to clinicians to recommend serum and urine testing for specimens collected < 14 days after symptom onset.

The xMAP® MultiFLEX™ Zika RNA Assay has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.

The test is available for purchase by laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The multi-target assay uses the Luminex 100/200 or MAGPIX instrument, or other authorized instruments, to simultaneously test for six genetic targets of the Zika virus.

“Together with our partner, GenArraytion, Inc., we have responded to this crisis and are currently in discussions with key public health, reference and hospital laboratories,” said Homi Shamir, President and CEO of Luminex. “As a leader in multiplex diagnostic testing for infectious diseases, we are proud to help enable healthcare providers to rapidly detect Zika virus with this assay today, and we intend to expand our coverage to include a broader array of mosquito-borne disease agents in the future to aid in treatment decisions for potentially afflicted patients.”

The FDA can use the EUA to permit use, based on scientific data, of certain medical products in certain circumstances, including when there is a determination by the Secretary of Health and Human Services that there is significant potential for a public health emergency.

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