AUSTIN, Texas, July 22, 2020 /PRNewswire/ -- Luminex Corporation
(NASDAQ: LMNX) today announced that it has submitted an EUA request
to the FDA for a new expanded version of its NxTAG®
Respiratory Pathogen Panel (RPP) to include the SARS-CoV-2 virus
for high-throughput COVID-19 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 the
most relevant circulating pathogen today, SARS-CoV-2.
Respiratory infections such as COVID-19 and influenza can be
challenging to differentiate and diagnose accurately because they
feature many of the same 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. With the addition of the SARS-CoV-2 virus, 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 and generate 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.
"Clinical laboratories are straining under the pressure of
COVID-19 testing, and the unfortunate reality is that even in these
incredibly challenging conditions, labs must now look ahead to the
coming flu season," said Nachum "Homi" Shamir, President and CEO of
Luminex. "We believe that syndromic respiratory testing will be a
critical tool for dealing with the seasonal flu outbreak that is
coming on top of a global pandemic. We incorporated the SARS-CoV-2
virus into our trusted NxTAG RPP panel to alleviate laboratory
capacity constraints and improve the ease of testing."
Since the start of the COVID-19 pandemic, Luminex has focused on
expanding capacity for SARS-CoV-2 diagnostic 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.
Earlier this month, the company announced it had received FDA EUA
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 third
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," "believe,"
"provide," "allows," 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 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