FDA gives emergency use authorization for xMAP MultiFLEX Zika RNA Assay for Zika Virus detection- Luminex Corporation

Luminex Corporation has received Emergency Use Authorization (EUA) from the FDA for a multiplex nucleic acid test called the xMAP MultiFLEX Zika RNA Assay designed to detect Zika virus RNA in potentially infected patients using their blood serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen). 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.

Systems using xMAP Technology perform discrete assays on the surface of color coded beads known as microspheres, which are then read in a compact analyzer. Using multiple lasers or LEDs and high-speed digital-signal processors, the analyzer reads multiplex assay results by reporting the reactions occurring on each individual microsphere.