AUSTIN, Texas, March 4, 2021 /PRNewswire/ -- Luminex Corporation
(NASDAQ: LMNX) today announced that it has received Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration
(FDA) for a new expanded version of its NxTAG®
Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus
for high-throughput respiratory testing. The new test is a
combination of the company's original NxTAG RPP, an FDA-cleared in
vitro diagnostic for syndromic respiratory infection testing, and
SARS-CoV-2.
Respiratory infections such as COVID-19 and influenza can be
challenging to differentiate and diagnose because they often have
overlapping symptoms. NxTAG RPP is a multiplex, high-throughput
test designed to enable simultaneous detection of the most common
respiratory pathogens for a fast, syndromic testing approach.
Following the addition of the SARS-CoV-2 virus target, the panel
now includes 19 viral and 2 bacterial targets, combining the most
common respiratory pathogens in one panel to help facilitate the
rapid identification of various individual and co-occurring
infectious pathogens.
NxTAG RPP provides scalable throughput, allowing clinical labs
to run up to 96 samples at a time—generating results in
approximately four hours with minimal hands-on time. The test runs
on Luminex's easy-to-use, compact MAGPIX® System and is
designed for use in high-complexity molecular laboratories.
Importantly, the NxTAG RPP + SARS-CoV-2 Assay is expected to
detect new variants of the coronavirus. An in silico analysis of
molecular probes used in the assay compared to SARS-CoV-2 sequences
available in the GISAID database as of February 11, 2021, determined that key sequences
still match and should yield a positive result. The analysis
included variants originally detected in the United Kingdom (B.1.1.7), South Africa (B.1.351 or 20H/501Y.V2),
Brazil (P.1 lineage or
20J/501Y.V3), and California (one
of five reoccurring mutations that constitute the B.1.429 lineage
and CAL20C).
"Given the emergence of new respiratory pathogens and new
variants of these pathogens, it will be increasingly challenging to
identify and distinguish the presence and co-existence of
SARS-CoV-2, influenza, and other common respiratory pathogens. As a
highly accurate, low-cost, multiplex test, our NxTAG RPP +
SARS-CoV-2 test delivers an ideal solution for this challenge,"
said Nachum "Homi" Shamir, Chairman, President and CEO of
Luminex. "Clinical laboratories using the assay will be able to
scale-up their testing for both COVID-19 and the flu with one
high-capacity diagnostic platform that can provide much-needed
information for appropriate patient treatment. This is especially
important given that the symptoms for the flu, COVID-19, and other
respiratory illnesses can be very similar, but their treatment may
be very different."
A version of the assay, which also detects Legionella
pneumophila and the 2009 H1N1 Flu A subtype, also just received
a CE Mark, and was commercialized last month in Europe.
Since the COVID-19 pandemic began, Luminex has expanded capacity
for SARS-CoV-2 testing across all of its molecular platforms. The
company previously launched the NxTAG CoV Extended Panel under an
EUA from the FDA and an Authorization for Import or Sale with
Conditions from Health Canada, and also received FDA EUA for its
ARIES® SARS-CoV-2 Assay. In August, the company
announced it received an EUA from the FDA for its
xMAP® SARS-CoV-2 Multi-Antigen Immunoglobulin G
(IgG) Assay, a new serology test that can be run on any of
Luminex's xMAP-based, high-throughput, gold-standard multiplex
platforms. The test detects IgG antibodies, which are an important
component of an adaptive immune response and typically reflect
sustained immunity to a given pathogen.
The NxTAG CoV Extended Panel and the
ARIES® SARS-CoV-2 Assay have each been funded
with $642,450 of Federal funds, approximately 36% each of
the expected overall cost of development, from the Department
of Health and Human Services; Office of the
Assistant Secretary for Preparedness and
Response; Biomedical Advanced Research and Development
Authority, Division of Research Innovation and
Ventures under Contract Nos. 75A50120C00037 (NxTAG CoV
Extended Panel) and 75A50120C00043
(ARIES® SARS-CoV-2
Assay). Luminex financed the remaining $1,118,663 of
each program, constituting 64% each of the total program costs.
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 "can," "will," "allowing,"
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 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