FDA authorizes emergency use of Zika virus molecular detection assay

Luminex (Austin, TX) has received Emergency Use Authorization (EUA) from the FDA for its xMAP MultiFLEX Zika RNA assay, a multiplex nucleic acid test that detects Zika virus RNA in potentially infected patients using their blood serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen).

In July 2016, the Centers for Disease Control and Prevention (CDC) updated its guidance to clinicians to recommend serum and urine testing for specimens collected <14 days after Zika virus symptom onset. The xMAP MultiFLEX Zika RNA assay, designed by the company's partner GenArraytion (Rockville, MD), combines optofluidics and digital signal processing with proprietary microsphere technology to deliver multiplexed assay capabilities. The test 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 company plans to expand the assay's coverage to include a broader array of mosquito-borne disease agents in the future to aid in treatment decisions for potentially afflicted patients, according to Nachum "Homi" Shamir, president and CEO of Luminex.

For more information, please visit www.luminexcorp.com.

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