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Luminex Corporation Receives FDA Emergency Use Authorization for Zika Virus Molecular Detection Assay

Luminex Corporation announced that it has received Emergency Use Authorization (EUA) from the U.S. 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."

About the FDA's Emergency Use Authorization (EUA)

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.

About xMAP® Technology

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.

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