AUSTIN, Texas, March 4, 2020 /PRNewswire/ -- As the rapidly
changing situation associated with the Wuhan coronavirus, now known as SARS-CoV-2,
continues to evolve both in the United
States and around the world, Luminex Corporation
(NASDAQ:LMNX) announced today updates on the company's plans,
progress, and capabilities in assisting laboratories to detect and
diagnose cases of this novel coronavirus disease (COVID-19).
"We have been working on multiple solutions to augment our NxTAG
and ARIES offerings in order to facilitate and automate the
detection of SARS-CoV-2," said Nachum "Homi" Shamir, President
and CEO of Luminex. "These additional alternatives leverage our
globally available instrument platforms and assay technologies.
They should be especially helpful to laboratories throughout
the United States, given the
recently released guidance from the Food and Drug Administration
concerning high-complexity testing under CLIA prior to Emergency
Use Authorization (EUA) for SARS-CoV-2."
Luminex anticipates making two different solutions available for
SARS-CoV-2 testing:
- NxTAG® CoV Expanded Panel. Luminex has
developed a unique multiplex panel that addresses the current
coronavirus outbreak using its existing bead-based NxTAG
Technology. This expanded panel has undergone initial testing using
samples at Chinese Center for Disease Control and Prevention (China
CDC) locations. Early results seem very promising and the company
expects to conclude this testing in the next several days. In
addition, Luminex has begun validation in the United States at a number of existing
customer facilities. This panel should be available to ship to
customers in a few weeks, under the terms of the EUA listed
above.
This expanded panel includes three gene targets for SARS-CoV-2
(ORF, E-gene, and N-gene), as well as SARS-CoV and MERS-CoV, and
will be the first assay panel globally that will be able to
simultaneously test for each of these coronavirus strains.
Luminex's NxTAG® Respiratory Pathogen Panel (RPP), which
was cleared by the FDA and other worldwide agencies more than four
years ago, can be run in parallel with the expanded outbreak panel
to identify and/or rule out both existing and novel respiratory
infections. The existing RPP test and this new expanded panel are
both plate-based, high-throughput, low-cost solutions that run on
the MAGPIX® instrument. This combination of assays
offers labs an ideal solution for their anticipated high-volume
testing of respiratory infections, including both flu and other
coronaviruses.
- SARS-CoV-2 Target on ARIES®. In addition,
Luminex has evaluated a single-target test on the ARIES®
System for SARS-CoV-2. The company has had two European reference
labs successfully validate a multi-targeted test using the
ARIES® System and are also currently validating the test
with customers in the United
States. ARIES® uses real-time PCR technology
that, when combined with its ability to run laboratory developed
tests (LDTs), is ideally suited for situations such as the current
pandemic. This SARS-CoV-2 target incorporates the latest U.S.
Centers for Disease Control and Prevention (CDC) primer sequences
and is currently available to customers who use the
ARIES® System. This testing can be validated by
qualifying laboratories under the aforementioned EUA path. The
ARIES® System currently has seven FDA cleared assays,
including Flu A/B & RSV.
"Offering multiple solutions is a key part of Luminex's focus on
providing value and flexibility to our current and future
customers," said Shamir. "The assays we are working on will
assist both laboratories and clinicians that need to detect
SARS-CoV-2 on its own, as well as those that may need a more
complete picture of potential causes of respiratory
infections—including targets that are both common and novel in
nature. In addition, Luminex's VERIGENE® RP Flex
Test, NxTAG RPP, and ARIES® Flu A/B & RSV assays are
all able to provide exclusion testing as laboratories grapple with
the emerging COVID-19 situation during the flu/respiratory season.
Given the expanding scope of this outbreak, it seems likely that we
could be battling COVID-19 for the foreseeable future.
"We are unable to quantify at this time what, if any, material
financial impact these efforts will have, and are not making any
adjustments to our current expectations. We look forward to
providing additional updates as they become available," said
Shamir.
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 for the first quarter, as well as
other statements that refer to future plans and expectations,
particularly around the development of products to address the
novel coronavirus. Such statements involve a number of risks and
uncertainties. Words such as "expect," "believe," "confident,"
"unable," "seem," "would," "should," "could," "can" 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 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 T.
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