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.
![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. The ARIES® Bordetella Assay is indicated for use with ARIES® Systems.](https://mma.prnewswire.com/media/507266/ARIES_Bordetella.jpg)
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