AUSTIN, Texas, May 3, 2017 /PRNewswire/ -- Luminex
Corporation (NASDAQ: LMNX) today announced that it has received FDA clearance for the ARIES® Bordetella Assay
for direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis
(B. parapertussis) nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a
respiratory tract infection attributable to B. pertussis or B. parapertussis. This is the fourth assay the FDA has
cleared since October 2015 for use on Luminex's ARIES® Systems. The company has also
achieved CE-IVD marking for the ARIES® Bordetella Assay, is preparing to submit its Clostridium
difficile assay to the FDA later this month, and is in the process of completing a Group A Streptococcus
clinical trial as it seeks to further expand its ARIES® menu.
Pertussis, commonly known as whooping cough, is a contagious respiratory disease caused by the organism Bordetella
pertussis. This infection can lead to life-threatening complications in infants and young children. Worldwide, there are an
estimated 16 million cases of pertussis and about 195,000 deaths per year. The CDC states that there has been an increase in the
number of reported cases of pertussis in the United States since the 1980s.
According to the CDC, "Early signs and symptoms of pertussis are often non-specific, making it difficult to determine
clinically who has pertussis in the earliest stages. However, only patients with signs and symptoms consistent with pertussis
should be tested by PCR to confirm the diagnosis." They note that testing asymptomatic persons should be avoided due to the
likelihood of obtaining false-positive results. The ARIES® Bordetella Assay is a real-time polymerase chain
reaction (PCR)-based qualitative in vitro diagnostic test that targets the pertussis toxin (ptxA) promoter and IS1001 repeat
sequence in the genomes of B. pertussis and B. parapertussis, respectively.
John W. Longshore Ph.D., Director of Molecular Pathology at the Carolinas HealthCare System, commented: "Healthcare systems
like ours will benefit from having a molecular assay for B. pertussis and B. parapertussis available in a moderate
complexity sample to answer format. The newly cleared Bordetella assay from Luminex should aid in efficient patient
diagnosis and B. pertussis reporting to the CDC."
ARIES® Systems automate all aspects of testing, from sample preparation through analysis, providing answers in less
than 2 hours with minimal hands-on time. The ARIES® Bordetella Assay is part of Luminex's comprehensive
respiratory testing menu that also includes: ARIES® Flu A/B & RSV, VERIGENE® RP Flex, and
NxTAG® RPP.
"The high specificity of our Bordetella Assay combined with the rapid results provided by the ARIES®
platform should lead to more positive patient outcomes," according to Homi Shamir, President and
Chief Executive Officer of Luminex. "The ARIES® Bordetella Assay is a cost-effective option for lower volume
labs desiring high-performance molecular testing, and is part of a growing menu of tests from Luminex that can be adapted to fit
the respiratory testing needs of any clinic."
About ARIES ® Systems
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.
To learn more or request a demo, visit: http://www.luminexcorp.com/ARIES
About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing
health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical
drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable
answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit
us at 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 available market and customer acceptance for ARIES ® , future revenue growth anticipated for
ARIES ® , and the development, testing and regulatory approval progress of our pipeline products, including
ARIES ® related assays. 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, 512.219.8020
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com
Luminex Media Contact
Christine Valle, 512.219.8020
Sr. Manager, Global Marketing Communications
cvalle@luminexcorp.com
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SOURCE Luminex Corporation