Luminex Corporation Receives FDA Clearance for New Molecular Test for Identification and Differentiation of Influenza A/B and Respiratory Syncytial Virus

The ARIES^® Flu A/B & RSV Assay delivers results in less than 2 hours for the detection and differentiation of three key respiratory pathogens:  influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) using a sample to answer platform. This new assay also allows for panel customization with the unique ability to only report the results of interest.  

"Clinical labs everywhere are trying to accomplish more with less these days, so we need each instrument to perform more tasks," said Dr. Stefan Juretschko, Director, Infectious Diseases Diagnostics, Northwell Health. "The ARIES^® platform lets us run samples as they come in and turn results around quickly. With FDA-cleared assays as well as the ability to run lab-developed tests, it offers us unmatched flexibility."

"In the battles clinicians wage to fight infectious disease, accurate and quickly actionable diagnostic test results are critical for success. The ARIES^® Flu A/B & RSV Assay requires very limited hands-on time that accelerates the time to result and provides for increased accuracy," said Nachum "Homi" Shamir, President and CEO of Luminex Corporation. "We are proud to have received our second FDA clearance for an ARIES^® assay, are delighted that these new clinical tests are being embraced by our customers, and look forward to further expansion of our ARIES^® menu."

To learn more or request a demo, please visit: http://www.luminexcorp.com/ARIES.

Luminex has also received FDA clearance for the ARIES^® HSV 1&2 Assay for use on the ARIES^® Systems. Both the HSV 1&2 and Flu A/B & RSV assays have also received CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.

About the ARIES Systems and Flu A/B & RSV Assay 
ARIES^® Systems are sample to answer molecular diagnostic systems designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today's lean laboratory environment. ARIES^® uses internal barcode scanning and other advanced features to minimize operator errors. Independent modules support from one to six cassettes, allowing for both STAT and Batch testing of IVD assays and laboratory developed tests (LDTs) with MultiCode^® Reagents when using a universal assay protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space.

The ARIES^® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid from nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C.

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/.

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.

Contacts

Luminex Investor Contact
Harriss Currie
Sr. Vice President of Finance and CFO
512.219.8020
[email protected]

Luminex Media Contact
Christine Valle
Sr. Manager, Global Marketing
512.219.8020
[email protected]

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SOURCE Luminex Corporation

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