AUSTIN, Texas, July 14, 2015 /PRNewswire/ -- Luminex
Corporation (NASDAQ: LMNX) today announced that it has submitted
510(k) applications to the FDA for the company's ARIES™ System and
ARIES™ HSV 1&2 Assay. The company anticipates receiving FDA
clearance and CE-IVD marking before the end of the year.
"The FDA submission for the ARIES platform represents the
culmination of years of development work. In ARIES, we believe we
have a truly differentiated product that will resonate quite
favorably with laboratory customers," said Homi Shamir, President and CEO of Luminex. "As
we near the commercial launch of the system, scheduled for later
this year, we are excited to enter the next phase of the company's
future, with an ever-increasing focus on the molecular diagnostics
market, rapidly expanding the ARIES menu and driving top-line
revenue growth."
"We really like the ARIES System's random batch design. ARIES is
robust, flexible, with the right throughput. The ability to mix and
match assays in the same run is a great fit for our workflow," said
Dr. Anami Patel, Technical Director
of LeBonheur Children's Hospital, an early access site for ARIES.
"ARIES is very easy to operate and has some novel, attractive
features in the software. In addition, the paperless reporting
combined with the fast assay turnaround time makes ARIES a good
solution to support our physicians by delivering high quality
patient care."
Clinical trials for the ARIES C. difficile Assay and the
ARIES Group B Streptococcus (GBS) Assay are progressing, and
the company expects to launch clinical trials for additional ARIES
products prior to the end of the year.
About ARIES
ARIES is a sample to answer system designed to deliver
superior laboratory performance, increase laboratory efficiency,
and fit seamlessly into today's lean laboratory environment.
ARIES uses internal barcode scanning and other advanced
features to minimize operator errors. Two independent
magazine modules each support from one to six cassettes,
allowing for both STAT and Batch testing. Simultaneous IVD and
Laboratory Developed Tests (LDTs) can operate through a common
Universal Assay Protocol. An integrated touch-screen PC
eliminates the need for a separate computer, stand-alone
keyboard, and mouse; thus maximizing valuable bench
space.
To learn more or request a demo, visit:
http://www.luminexcorp.com/ARIES
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, including ARIES and related assays, 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, 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