AUSTIN, Texas, Feb. 24, 2020 /PRNewswire/ -- Luminex
Corporation (NASDAQ: LMNX) today announced that the company
has submitted an application to the U.S. Food and Drug
Administration (FDA) for 510(k) clearance of the
VERIGENE® II Respiratory Flex Assay, the second
VERIGENE II assay to be submitted to the agency. The
VERIGENE® II Respiratory Flex (RSP
Flex) Assay is a multiplexed, qualitative test for
simultaneous detection and identification of common viruses and
bacteria from nasopharyngeal swabs that are obtained from
individuals suspected of respiratory tract infection.
This assay, along with the Gastrointestinal (GI) Flex
Assay, both run on Luminex's new VERIGENE II system. The GI
Flex Assay is an automated test for the detection and
identification of enteric bacteria, viruses, parasites, and toxins
in stool samples. Both are now under review with the FDA, and
Luminex anticipates launching the new VERIGENE II assays
mid-year.
"We are delivering on our strategy and our promise to expand the
menu of clinically relevant, high-value tests that accelerate and
simplify diagnostic testing," said Homi Shamir, President and
CEO of Luminex. "We're also demonstrating once again the
cost-effectiveness of rapid testing on a Luminex platform. The
flexibility of the automated VERIGENE II System uniquely
allows clinical laboratories to select, test and pay for only the
targets ordered for each patient. This is a game-changer for many
laboratories."
The VERIGENE II System is a benchtop molecular diagnostic system
that uses advanced automation and specialized chemistry to enable
rapid, sample-to-result detection. The RSP Flex Test is
performed on this system utilizing reverse transcription,
polymerase chain reaction, and array hybridization to detect
specific respiratory viral and bacterial pathogen nucleic-acid gene
sequences.
"By expanding the foundational assays on our next-generation
VERIGENE system to a wider variety of common viruses and bacteria,
we are helping laboratories deliver fast, accurate results and are
streamlining the process of sample testing," said Shamir.
When targeted therapies depend on clinical test results, testing
of nasopharyngeal samples for specific pathogens is highly useful,
especially given that respiratory tract infections (RTIs) are among
the three most common acute illnesses evaluated in outpatient
care.1 Children are particularly vulnerable to RTIs,
with an average of six per year.2 If these illnesses are
not diagnosed accurately or quickly enough, they can lead to more
serious illness and, in severe cases, to increased childhood
mortality. The VERIGENE II RSP Flex Assay delivers a
critical test that is designed to address this widespread and
costly challenge.
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
Statements made in this release that express
Luminex's or management's intentions, plans, beliefs, expectations
or predictions of future events are forward-looking statements.
Forward-looking statements in this release include statements
regarding the available market and customer acceptance for the
VERIGENE II Respiratory Flex Assay, VERIGENE II GI Flex Assay, and
the VERIGENE® II System. Expressions such as "looking to" are
intended to further identify such forward-looking statements for
purposes of the Private Securities Litigation Reform Act of 1995.
It is important to note that the Company's actual results or
performance could differ materially from those anticipated or
projected in such forward-looking statements. Factors that could
cause Luminex's actual results or performance to differ materially
include risks and uncertainties relating to, among others, market
demand and acceptance of Luminex's products and technology;
Luminex's ability to obtain and enforce intellectual property
protections on Luminex's products and technologies; Luminex's
ability to successfully launch new products in a timely manner;
competition and competitive technologies utilized by Luminex's
competitors; as well as the risks discussed under the heading "Risk
Factors" in Luminex's Reports on Forms 10-K and 10-Q, as filed with
the Securities and Exchange Commission. The forward-looking
statements contained herein represent the judgment of Luminex as of
the date of this press release, and Luminex expressly disclaims any
intent, obligation or undertaking to release publicly any updates
or revisions to any forward-looking statements to reflect any
change in Luminex's expectations with regard thereto or any change
in events, conditions or circumstances on which any such statements
are based.
Investor Contacts:
Harriss
Currie, 512.219.8020
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com
Jeff Christensen,
512.249.3033
Senior Director, Investor Relations
jeffc@luminexcorp.com
Media Contact:
Michele
Parisi, 925.864.5028
Bioscribe
mparisi@bioscribe.com
1 Micah T. and Bomar P. Upper Respiratory Tract
Infection. December 16, 2019.
Accessed February 18, 2020.
https://www.ncbi.nlm.nih.gov/books/NBK532961/
2 Tesini, B.L. Overview of Viral Respiratory Tract
Infections in Children. Merck Manual. September 2019. Accessed February 18, 2020.
https://www.merckmanuals.com/home/children-s-health-issues/viral-infections-in-infants-and-children/overview-of-viral-respiratory-tract-infections-in-children
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SOURCE Luminex Corporation