Luminex Corporation Receives U.S. Food and Drug Administration Clearance for xTAG(TM) Respiratory Viral Panel
January 03 2008 - 1:17PM
Business Wire
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.�
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