AUSTIN, Texas, March 10, 2021 /PRNewswire/ -- Luminex
Corporation (NASDAQ: LMNX) today announced that it has submitted an
Emergency Use Authorization application to the U.S. Food and Drug
Administration for the company's new multi-analyte respiratory
panel combining Flu A/B and respiratory syncytial virus (RSV)
targets with the SARS-CoV-2 target. The ARIES® Flu A/B
& RSV+SARS-CoV-2 Assay can be run on all Luminex
ARIES® Systems. This submission represents completion of
a key milestone in a Luminex funding award from the Biomedical
Advanced Research and Development Authority (BARDA), which helped
support the rapid development and validation of the assay.
Respiratory infections such as COVID-19 and influenza can be
challenging to differentiate and diagnose because they often have
overlapping symptoms. Luminex designed the combined assay to
quickly deliver clear answers about these infections from a single
test and, thereby, help clinical-care teams treat patients more
effectively. The ARIES® Flu A/B & RSV+SARS-CoV-2
Assay can be run on six-unit and 12-unit ARIES® Systems
with minimal hands-on time, producing results in approximately two
hours. The ARIES® System is an FDA-cleared,
sample-to-answer, automated molecular diagnostics platform designed
for use in moderate and high complexity labs.
Importantly, the ARIES® Flu A/B & RSV+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).
"We are grateful to BARDA for supporting development of this
important new assay, and are pleased to have fulfilled our
commitment to file for EUA so quickly," said Nachum "Homi" Shamir,
Chairman, President and CEO of Luminex. "It is critical to continue
expanding the number of FDA-authorized assays that include
SARS-CoV-2 detection for a broad range of clinical uses, and we're
proud to have developed a single assay that provides answers about
some of the most common respiratory infections – including
SARS-CoV-2 - in just two hours."
BARDA is part of the US Department of Health and Human Services
and is tasked with protecting the country against emerging
infectious diseases and other threats. Through public-private
partnerships, BARDA supports the development of vaccines, drugs,
and diagnostics. Luminex developed the original ARIES®
SARS-CoV-2 Assay with financial support from BARDA earlier this
year.
Since the COVID-19 pandemic began, Luminex has expanded capacity
for SARS-CoV-2 testing across its diagnostic 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. It also received an EUA
from the FDA for its xMAP® SARS-CoV-2 Multi-Antigen
Immunoglobulin G (IgG) Assay, a serology test that can be run on
any of Luminex's xMAP-based, high-throughput, gold-standard
multiplex platforms.
This project has been funded in whole or in part with Federal
funds 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
No. 75A50121P00025.
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. To learn more
about Luminex's COVID-19 Testing and Research Solutions, please
visit: https://www.luminexcorp.com/solutions/.
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," "designed" 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 Relations Contacts:
Harriss Currie
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com
512-219-8020
Carla Stanaford
cstanaford@luminexcorp.com
937-469-2120
Media Contact:
Michele Parisi
Bioscribe
mparisi@bioscribe.com
925-864-5028
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SOURCE Luminex Corporation