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FDA grants emergency use authorization for Luminex's Zika Virus molecular detection assay

MDBR Staff Writer Published 09 August 2016

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Luminex's xMAP MultiFLEX Zika RNA assay.

Designed by Luminex partner GenArraytion, the multiplex nucleic acid test will detect Zika virus RNA in potentially infected patients using their blood serum, plasma, or urine.

The xMAP technology aggregates advanced fluidics, optics, and digital signal processing with proprietary microsphere technology to deliver multiplexed assay capabilities.

It is said to allow multiplexing of biological tests, in addition to reducing time, labor and costs compared to traditional methods such as ELISA, western blotting, PCR, and traditional arrays.

The FDA has not yet approved MultiFLEX Zika RNA assay. It 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 or diagnosis of Zika virus infection.

By using Luminex 100/200 or Magpix instrument, the assay will simultaneously test six genetic targets of the Zika virus.

The company will provide the assay for laboratories, which are certified under the clinical laboratory improvement amendments of 1988 (CLIA) to carry out high complexity tests.

Luminex president and CEO Nachum Homi Shamir said: "We are pleased that our innovative xMAP MultiFLEX Zika RNA assay has been granted emergency use authorization by the FDA.  

“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.”

GenArraytion CEO Paul Schaudies said: “Luminex molecular assays simultaneously detect multiple Zika targets and can detect the disease-causing viral pathogen earlier than serology assays.”

Image: Aedes aegypti mosquito will spread Zika fever. Photo: courtesy of James Gathany.