AUSTIN, Texas, Jan. 4, 2017 /PRNewswire/ -- Luminex
Corporation (NASDAQ: LMNX) today announced that it has received FDA
clearance for the ARIES® Group B Streptococcus (GBS) Assay
for antepartum detection of GBS colonization in pregnant women.
This is the third assay the FDA has cleared for use on the Luminex
ARIES® Systems. The company has also achieved CE-IVD marking
for the ARIES® GBS Assay.
Infection with Group B Streptococcus (GBS),
also known as Streptococcus agalactiae, is a
leading cause of neonatal morbidity and mortality, causing
meningitis, pneumonia and septicemia in newborns and their mothers.
One in four pregnant women are colonized with GBS, with most not
exhibiting symptoms; however, it can be transmitted to the newborn
during delivery. If not treated, GBS can result in illness or even
death in the first week of a newborn's life. The Centers for
Disease Control and Prevention recommends universal GBS testing of
women in their 35th-37th week of pregnancy.1
The ARIES® GBS Assay is a real-time polymerase chain reaction
(PCR) based qualitative in vitro diagnostic test designed to
detect Group B Streptococcus nucleic acid from 18-24 hour
Lim broth enriched vaginal-rectal swab specimens obtained from
pregnant women. It offers higher sensitivity and increased accuracy
when compared to culture, and a reduced turnaround time of two
hours after enrichment, compared to 48 hours for culture, with
simultaneous STAT and batch testing on the sample to answer ARIES®
Systems.
"We found the Luminex GBS assay to be user friendly, and its
streamlined workflow is simpler than most other tests we have
evaluated," said Thomas E. Davis,
MD, PhD, Culbertson Professor of Pathology at Indiana University. "Fortunately, most GBS
infections can be prevented by antenatal screening and
administration of antibiotics during delivery to women determined
to be GBS-positive. By providing fast and accurate results, the
Luminex GBS assay could support these efforts to keep women and
their babies safe."
"The high level of sensitivity and accuracy of the ARIES® GBS
Assay over culture tests will aid in the diagnosis of more
patients, ensure better quality of care, and increase patient and
clinician confidence in the results," said Homi Shamir, President and Chief Executive
Officer of Luminex. "We are delighted to have received our third
FDA clearance for an assay indicated for use with our new ARIES®
Systems and to launch our first product for antenatal testing,
increasing the value we can provide to clinicians, women, and
children at a time when their need is at its greatest. We expect to
accelerate the launch of additional ARIES® assays as we move into
2017."
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 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.
References:
1. About Group B Strep. Centers for Disease Control and
Prevention (Internet). Cited 2015 June. Available from:
http://www.cdc.gov/groupbstrep/about.
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
cvalle@luminexcorp.com
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SOURCE Luminex Corporation