AUSTIN, Texas, Aug. 8, 2016 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today 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.
About Luminex Corporation
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 researchers. Luminex's technology is commercially available worldwide and in use in leading clinical laboratories, as well as major pharmaceutical, diagnostic, biotechnology and life-science companies. Luminex is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research and food safety. For further information on Luminex Corporation and the latest advances in multiplexing using award winning technology, please visit http://www.luminexcorp.com/.
Based in Rockville, Md., GenArraytion, Inc. is a privately held, veteran-owned, small business dedicated to the development and commercialization of multiplexed molecular assays for infectious diseases. GenArraytion is dedicated to improving healthcare through the development and distribution of treatment-guiding molecular assays for infectious disease markets, environmental and epidemiological applications, and veterinary and biodefense markets. GenArraytion MultiFLEX™ Bioassays improve infection prevention, response and treatment. For more information, visit www.genarraytion.com or email firstname.lastname@example.org.
Statements made in this release that express Luminex's or management's intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward-looking statements in this release include statements regarding the development and testing progress of our pipeline products, and the regulatory approvals thereof. The words "believe", "expect", "intend", "anticipates", "confident", "will", "could", "should", and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company's actual results or performance could differ materially from those anticipated in such forward-looking statements. Factors that could cause Luminex's actual results or performance to differ materially include risks and uncertainties relating to, among others, our ability to launch products on time, the timing of regulatory approvals, the outcome of clinical trials as well as the risks discussed under the heading "Risk Factors" in Luminex's Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission. The forward looking statements contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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SOURCE Luminex Corporation