Luminex (NASDAQ:LMNX)
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Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed
solutions, today announced that it has received 510(k) clearance from
the U.S. Food and Drug Administration (FDA) for its xTAG™
Respiratory Viral Panel (RVP). xTAG RVP is the first
FDA-cleared assay to simultaneously detect and identify 12 viruses and
viral subtypes that together are responsible for more than 85 percent of
respiratory viral infections.
xTAG RVP is a groundbreaking test that, with a single patient sample,
can assess the presence or absence of 12 viral targets and provide
qualitative results in a few hours. Traditional testing for this many
viruses requires multiple individual diagnostic tests to be performed on
a patient sample and can take several days to provide a thorough
diagnosis. The speed and reliability of xTAG RVP will help physicians
provide appropriate treatment, and prevent inappropriate antibiotic use
that has contributed to the creation of “superbugs.”
With a non-invasive, painless swab, xTAG RVP tests for:
Influenza A, influenza A-H1, influenza A-H3 and influenza B, which
cause the majority of flu cases in the U.S.;
Adenovirus, which is responsible for approximately 10 percent of
respiratory infections and a subtype of which the Centers for Disease
Control (CDC) have recently identified as causing multiple deaths;
Respiratory syncytial virus (RSV) A and B, the most common cause of
bronchiolitis and pneumonia in infants and children;
Metapneumovirus, a recently-discovered virus that causes flu-like
symptoms and is thought to be the second leading cause of respiratory
infection in children;
Parainfluenza 1, 2, and 3, which can cause upper or lower respiratory
infections in adults and children and, are thought to be responsible
for about half of croup cases and 10-15 percent of bronchiolitis and
bronchitis cases; and
Rhinovirus, which causes the common cold.
Created by Luminex Molecular Diagnostics in Toronto, and built on Luminex’s
flexible xMAP technology, xTAG RVP represents a number of “firsts.”
It is the first multiplexed nucleic acid test for respiratory viruses
cleared for in vitro diagnostic use by the FDA. It also is the first
test of any kind cleared to detect human metapneumovirus, the first test
cleared for influenza A subtyping, and the first molecular test cleared
for adenovirus.
“Because the symptoms of respiratory disease
overlap tremendously, it can be very difficult to determine whether an
illness is caused by a virus, and if so, which specific virus, or
bacteria,” said Christine C. Ginocchio,
Ph.D., Director, Microbiology/Virology and Molecular Diagnostics at
North Shore-LIJ Health System Laboratories. “The
xTAG RVP provides results on a broad range of viral pathogens, which
will assist in the diagnosis of respiratory infections and help
physicians recommend the appropriate treatment quickly. The test also
tells us what types of viruses are circulating in our communities, which
can assist physicians and public health officials in preventing
outbreaks.”
xTAG RVP’s unique ability to detect influenza
A subtypes H1 and H3 will allow it to play an important role in the
pandemic influenza monitoring plans of the U.S. Department of Health and
Human Services and the World Health Organization. The test will allow
public health officials to distinguish H1 and H3 subtypes, which
represent the vast majority of Influenza A subtypes, from rarer
subtypes. This way, the few samples that do test positive for Influenza
A but cannot be identified as H1 nor H3 subtypes can be flagged for
further investigation by the CDC or local public health labs.
Luminex’s xTAG RVP is the 43rd
xMAP-based product to receive 510(k) clearance by the FDA. xMAP is a
multiplexing technology that can simultaneously deliver up to 100
individual tests within a single sample.
“The approval of the Luminex xTAG RVP
is a critical milestone in the diagnosis, treatment and control of the
respiratory viruses that impact millions of individuals every year,”
said Patrick Balthrop, President and CEO of Luminex. “In
addition to helping improve the surveillance of viruses –
both in hospitals and community wide – this
test can significantly improve patient care. In a matter of hours,
rather than days, xTAG RVP can determine whether a patient has a
cold, the flu or another virus, allowing a doctor to prescribe an
effective treatment much more quickly.”
Respiratory viruses are the cause of significant morbidity and mortality
in the U.S. each year:
Respiratory viral infections are the 7th
leading cause of death in the United States, claiming the lives of
more than 60,000 annually.1
Respiratory viruses are responsible for 75-80 percent of doctor visits.2
Each year, up to 20 percent of U.S. residents get the flu. More than
200,000 people are hospitalized in the U.S. because of influenza and
36,000 die annually.3
There are 66 million colds in the U.S. every year.4
11 million adults and 5.3 million children (2.8 million under the age
of 5) are diagnosed with lower respiratory viral infections annually.
These viruses lead to the hospitalization of 208,000 adults and
430,000 children.5
Respiratory viruses also are a major cause of lost time from work and
school, resulting in significant financial and social losses. Annual
direct and indirect costs of these viruses in the U.S. are estimated at
more than $10 billion.6
Respiratory viruses are responsible for more than 80 percent of
respiratory infections.7 In many cases
antibiotics are prescribed to treat these viral infections. However,
antibiotics cannot change the course of illnesses caused by viruses.
With xTAG RVP, physicians will now have valuable information to help
them determine what their patients have and whether antibiotics are
needed. This test will assist in reducing the overuse of antibiotics,
which has contributed to the creation of antibiotic resistant bacteria
or superbugs.
With FDA 510(k) clearance, xTAG RVP is now available for
diagnostic use in the U.S. and can be purchased through Luminex
Molecular Diagnostics and Fisher HealthCare, part of Thermo Fisher
Scientific Inc. (NYSE: TMO). xTAG RVP has received CE mark
certification, allowing Luminex to market the product in Europe.
For more information on the xTAG RVP, please visit www.luminexcorp.com.
Luminex will host a conference call to discuss xTAG RVP today, Thursday,
January 3, 2008, at 4:30 Eastern Time. The conference call will be
webcast live and will be accompanied by a slide presentation, both of
which may be accessed at http://www.luminexcorp.com.
Simply log on to the web at the address above, go to the Company section
and access the Investor Relations link. Please go to the website at
least 15 minutes prior to the call to register, download and install any
necessary audio/video software.
About Luminex Corporation
Luminex Corporation develops, manufactures and markets proprietary
biological testing technologies with applications throughout the
diagnostic and life sciences industries. The Company's xMAP®
multiplex solutions include an open-architecture, multi-analyte
technology platform that delivers fast, accurate and cost-effective
bioassay results to markets as diverse as pharmaceutical drug discovery,
clinical diagnostics and biomedical research, including the genomics and
proteomics research markets. The Company's xMAP technology is sold
worldwide and is already in use in leading clinical laboratories as well
as major pharmaceutical, diagnostic and biotechnology companies. Further
information on Luminex Corporation or xMAP technology can be obtained at www.luminexcorp.com.
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. The words "believe,"
"expect," "intend," "estimate," "anticipate," "will," "could," "should"
and similar expressions 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, the
Company's dependence on strategic partners for development,
commercialization and distribution of products, concentration of the
Company's revenue in a limited number of strategic partners,
fluctuations in quarterly results due to a lengthy and unpredictable
sales cycle and bulk purchases of consumables, Luminex's ability to
scale manufacturing operations and manage operating expenses, gross
margins and inventory levels, potential shortages of components,
competition, the timing of regulatory approvals, the implementation,
including any modification, of the Company's strategic operating plans,
risks and uncertainties associated with implementing our acquisition
strategy and the ability to integrate acquired companies, including Tm
Bioscience Corporation, or selected assets into our consolidated
business operations, including the ability to recognize the benefits of
our acquisitions, 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.
1 Centers for Disease Control. About the Flu;
Influenza: The Disease. November, 2004. http://www.cdc.gov/flu/about/disease/htm.
Accessed June 2006.
2 Hing E, Cherry DK, Woodwell DA. National
Ambulatory Medical Care Survey: 2004 Summary. Advance Data from Vital
and Health Statistics; No. 374. Hyattsville, Maryland: National Center
for Health Statistics. 2006.
3 Centers for Disease Control. About the Flu;
Influenza: The Disease. November, 2004. http://www.cdc.gov/flu/about/disease/htm.
Accessed June 2006.
4 National Center for Health Statistics data,
1994.
5 National and regional estimates on hospital
use for all patients from the HCUP Nationwide Inpatient Sample (NIS);
The 2007 Infectious Disease Testing Market, the Venture Planning Group;
in-house calculations based on peer-reviewed literature.
6 White House Government National Strategy for
Pandemic Influenza.
7 Hodinka, R., 2005. William Beaumont Hospital’s
14th Annual Symposium on DNA Technology in the
Clinical Laboratory, “The Spread of
Respiratory Viruses.”