AUSTIN, Texas, March 13, 2020 /PRNewswire/ -- Luminex
Corporation (NASDAQ: LMNX) announced today that four independent
clinical laboratories have validated laboratory developed tests
(LDTs) for automated, rapid detection of the SARS-CoV-2 virus using
the sample-to-answer ARIES® System. These LDTs
demonstrate that high complexity laboratories using the
ARIES® System can immediately add novel coronavirus
diagnostics to their testing menu. This will be important for
helping to address soaring demand for coronavirus tests and will
allow laboratories to produce results in approximately two
hours.
Studies to verify the test parameters with contrived samples on
the ARIES® System were conducted by Baylor Scott and White Health (Temple, TX), Montefiore Medical Center
(Bronx, NY), Geisinger
(Danville, PA), and the
University of Louisville (Louisville, KY).
"As part of our broader work to make a difference in the battle
against the coronavirus pandemic, Luminex is supporting
laboratories in their efforts to detect and diagnose cases of
COVID-19," said Nachum "Homi" Shamir, President and CEO of Luminex.
"Independent validation of LDTs on our
ARIES® System will help labs to quickly meet the
high demand for testing around the world. We are honored that these
clinical labs have chosen to develop their coronavirus tests using
our ARIES® platform and are pleased that this work can
be easily reproduced at the hundreds of labs currently using the
ARIES® System."
Along with these validation studies, labs across Europe and the
United States are in the process of going live with their
LDTs using the ARIES® System, and Luminex intends to
submit an EUA for an ARIES® SARS-CoV-2 Assay next month.
The platform uses real-time PCR technology that, when combined with
its ability to run LDTs, is ideally suited for facilities that need
to develop their own lab-specific testing for which there is no
commercially available, FDA-cleared assay. The system provides the
flexibility to handle STAT or batch testing and is capable of
running different assays simultaneously.
Luminex has also launched and begun shipping its
NxTAG® CoV Extended Panel (RUO), a unique multiplex
panel that addresses the coronavirus pandemic using its existing
bead-based NxTAG Technology. A number of labs in the Far East,
Europe and North America have already validated this
panel and are planning to go live with it this week. In addition,
Luminex is planning to submit an EUA for this panel to the FDA by
the end of this month.
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 luminexcorp.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking
statements relating to Luminex's business outlook, as well as other
statements that refer to future plans and expectations,
particularly around the development of products to address the
novel coronavirus and the potential by Luminex customers or by
Luminex to seek Emergency Use Authorization (EUA) or for
high-complexity CLIA labs to perform testing for a limited period
in advance of potentially obtaining EUA, and around the potential
positive or negative impact of the novel coronavirus on our
business. Such statements involve a number of risks and
uncertainties. Words such as "can," "will," "already," "planning,"
"intends," and variations of such words and similar expressions are
intended to identify forward-looking statements. Statements that
refer to or are based on estimates, forecasts, projections,
uncertain events or assumptions, and anticipated trends in our
businesses or the markets relevant to them, also identify
forward-looking statements. Such statements are based on
management's expectations as of the date they were first made and,
except as required by law, Luminex disclaims any obligation to
update these statements to reflect future events or circumstances.
Forward-looking statements involve many risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied in such statements. Important factors that
could cause actual results to differ materially from the company's
expectations include changes in market conditions, supply
constraints and other disruptions, changes in laws or regulatory
policies or initiatives (for example, termination of a relevant EUA
declaration), changes in capital requirements, and other factors
set forth in Luminex's most recent Annual Report on Form 10-K filed
with the SEC and available at Luminex's website at
www.luminexcorp.com and the SEC's website at sec.gov.
Investor Contact:
Harriss Currie
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com
512-219-8020
Media Contact:
Michele Parisi
Bioscribe
mparisi@bioscribe.com
925-864-5028
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SOURCE Luminex Corporation