AUSTIN, Texas, July 20, 2020 /PRNewswire/ -- Luminex
Corporation (NASDAQ: LMNX) today announced that the Food and Drug
Administration (FDA) has issued an Emergency Use Authorization
(EUA) for the company's xMAP® SARS-CoV-2
Multi-Antigen IgG Assay. Clinical laboratories can now use this
serology assay to identify the presence of antibodies in people who
have been infected with the virus that causes COVID-19. The test
can be run on any of Luminex's xMAP-based high-throughput,
gold-standard multiplex platforms, providing a more comprehensive
and reliable assessment of immune response compared to conventional
serology testing methods.
Designed to simultaneously detect antibodies against three
antigens, the xMAP SARS-CoV-2 Multi-Antigen IgG
Assay delivers high-quality results for up to 96 patient
samples in under three hours. The assay detects antibodies of
the immunoglobulin class G (IgG), which are an important component
of an adaptive immune response and typically reflect sustained
immunity to a given pathogen.
The xMAP SARS-CoV-2 Multi-Antigen IgG Assay demonstrated
specificity of 100 percent in human serum and greater than 99
percent in human plasma, with sensitivity greater than 96 percent
for both human serum and plasma (>14 days post-symptom onset) in
clinical studies. The assay uses the advanced multiplexing
capabilities of xMAP instrumentation to reduce the risk of false
positives and false negatives, giving laboratories increased
confidence in the reliability of their test results.
"More than 17,000 xMAP systems have been sold to laboratories
around the world, and this FDA authorization creates important new
opportunities for these labs to rapidly expand their COVID-19
testing capabilities with a highly accurate serology-based assay,"
said Nachum "Homi" Shamir, President and CEO of
Luminex. "In close collaboration with our extensive network of
partners and customers, Luminex continues to be on the frontlines
in the mission-critical effort to address the current pandemic with
state-of-the-art testing and innovative technologies such as
xMAP."
The new multi-antigen IgG assay can be run on all xMAP
platforms, including MAGPIX®, the Luminex®
200, and FLEXMAP 3D®. The assay reduces time to results,
minimizes the volume of sample needed, and accelerates the testing
process without the need for excess labor, representing
advancements over commonly used ELISA-based antibody assays.
The xMAP-based serology test is the third COVID-19 Luminex test
to receive an EUA, joining the NxTAG® CoV Extended
Panel and the ARIES® SARS-CoV-2 Assay, which are
rapid, RNA-based SARS-CoV-2 diagnostic tests that received EUAs in
March and April of this year, respectively.
The SARS-CoV-2 Multi-Antigen IgG Assay is the first of several
serology tests that Luminex is developing and plans to take to
market through an EUA to help during the COVID-19 crisis.
Additionally, the company continues to support numerous customers
and partners developing innovative xMAP-based serology assays to
facilitate vaccine and therapeutic development, perform
epidemiologic studies, and better understand the extent and
duration of protective immunity.
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 xMAP® Technology
A
well-established platform for multiplex analysis with more than
50,000 peer-reviewed publications, 65+ Luminex global
partners offering 1,300+ kits and custom assay solutions, xMAP
Technology uses a bead-based multiplexing assay approach that can
rapidly detect and quantify multiple analytes in a single sample.
More information about xMAP Technology is available
at https://www.luminexcorp.com/xmap-technology/. Additional
information about xMAP's applications in serology-based testing can
be found at https://www.luminexcorp.com/serology-based-testing.
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 https://www.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," "plans,"
"accelerate," "creates," "providing," "delivers," "reduces,"
"minimizes," "continues," "develop" 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 Contacts:
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