Luminex Corporation,  a biotechnology company, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a multiplex nucleic acid test 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).

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 xMAP MultiFLEX Zika RNA Assay 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.

"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," said Nachum "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."

R. Paul Schaudies, CEO of GenArraytion, Inc. commented, "Luminex molecular assays simultaneously detect multiple Zika targets and can detect the disease-causing viral pathogen earlier than serology assays. We are excited to use the highly flexible Luminex platforms for the development of key emerging infectious disease markers."

Luminex's xMAP technology combines advanced fluidics, optics, and digital signal processing with proprietary microsphere technology to deliver multiplexed assay capabilities. Featuring a flexible, open-architecture design, xMAP technology can be configured to perform a wide variety of protein or nucleic acid assays quickly, cost-effectively and accurately. xMAP technology enables multiplexing of biological tests (assays), reducing time, labor, and costs over traditional methods such as ELISA, western blotting, PCR, and traditional arrays. 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.

Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP open-architecture multi-analyte platform, MultiCode real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researcher.