Prodesse's ProParaflu+(TM) Assay Cleared for US Marketing by FDA
November 24 2009 - 4:01PM
PR Newswire (US)
- Molecular Test Identifies Three Common Types of Parainfluenza
Viruses That Cause Lower Respiratory Tract Infections - SAN DIEGO,
Nov. 24 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated
(NASDAQ:GPRO) announced today that the US Food and Drug
Administration (FDA) has cleared for marketing Prodesse's
ProParaflu+(TM) assay, a molecular test that detects and
differentiates parainfluenza 1, 2 and 3 viruses, which cause lower
respiratory tract infections. Prodesse is a wholly-owned subsidiary
of Gen-Probe, a global leader in molecular diagnostics. "FDA
clearance of our 510(k) application for ProParaflu+ adds to
Prodesse's portfolio of molecular tests for respiratory infectious
diseases," said Eric Tardif, Gen-Probe's senior vice president of
corporate strategy and general manager of Prodesse. "Although
parainfluenza virus infections aren't serious in most people, they
can cause dangerous complications in young children, the elderly
and other patient groups. We believe our assay will be an important
tool to help physicians accurately identify these infections,
especially when the prevalence of other viruses is high." The
ProParaflu+ assay uses real-time RT-PCR (polymerase chain reaction)
to identify the parainfluenza 1, 2 and 3 viruses from nasal swabs.
The assay uses the same internal control as Prodesse's other tests
for respiratory infectious diseases, so a single nucleic acid
extract can be tested with any combination of these products.
Prodesse markets these respiratory tests in the United States: --
ProFlu+(TM), which received FDA clearance in 2008 to detect and
differentiate influenza A virus, influenza B virus, and respiratory
syncytial virus (RSV). -- Pro hMPV+(TM), which received FDA
clearance in 2008 to detect human metapneumovirus. --
ProFlu-ST(TM), which is available under an FDA emergency use
authorization (EUA) to be used in CLIA high complexity laboratories
for the diagnosis of 2009 H1N1 influenza virus infection, aided by
an algorithm that relies on seasonal influenza A/H1 virus and
seasonal influenza A/H3 virus results, from a single sample in
individuals who are diagnosed with influenza A by currently
available FDA-cleared or authorized devices. The real-time RT-PCR
technology used in Prodesse's assays is simple to use and easily
integrates into a lab's existing workflow. All products have been
optimized for use with automated extraction technology that
minimizes technician hands-on time. This ease-of-use enables labs
to quickly validate the products. Test results can be obtained in
as little as three hours using the assays - a significant
improvement over culture-based methods that can take up to weeks to
produce a result. About Parainfluenza Viruses According to the US
Centers for Disease Control and Prevention (CDC), parainfluenza
viruses are second to RSV among causes of lower respiratory tract
disease in young children. Similar to RSV, parainfluenza viruses
can cause repeated infections throughout life, usually manifested
by an upper respiratory tract illness such as a cold or sore
throat. With repeat infection, parainfluenza viruses can also cause
serious lower respiratory tract disease such as pneumonia and
bronchitis, especially among the elderly and patients with
compromised immune systems. There are four types of parainfluenza
viruses, each with different clinical and epidemiologic features.
The most distinctive clinical feature of parainfluenza 1 and 2 is
croup; type 1 is the leading cause of croup in children. Both
parainfluenza 1 and 2 can cause other upper and lower respiratory
tract illnesses, while type 3 is more often associated with
bronchiolitis and pneumonia. Parainfluenza 4 is infrequently
detected, possibly because it is less likely to cause severe
disease. Parainfluenza viruses are spread from respiratory
secretions through contact with infected people or contaminated
objects. The viruses are ubiquitous and infect most people during
childhood. Parainfluenza 1 causes biennial outbreaks of croup in
the fall (now during odd-numbered years in the United States). Type
2 causes annual or biennial fall outbreaks. Parainfluenza 3
activity peaks during the spring and early summer months each year,
but the virus can be isolated throughout the year. About Gen-Probe
Gen-Probe Incorporated is a global leader in the development,
manufacture and marketing of rapid, accurate and cost-effective
nucleic acid tests (NATs) that are used primarily to diagnose human
diseases and screen donated human blood. Gen-Probe has more than 25
years of NAT expertise, and received the 2004 National Medal of
Technology, America's highest honor for technological innovation,
for developing NAT assays for blood screening. In October,
Gen-Probe completed its acquisition of Prodesse, Inc. Prodesse
develops molecular diagnostic reagents for a variety of infectious
disease applications. Prodesse sells four FDA 510(k) cleared
products in the United States, and three additional CE-marked
products in Europe. Caution Regarding Forward-Looking Statements
Any statements in this news release relating to Gen-Probe's
expectations, beliefs, plans, objectives, assumptions or future
events or performance are not historical facts and are
forward-looking statements. These statements are often, but not
always, made through the use of words or phrases such as believe,
will, expect, anticipate, estimate, intend, plan and would. For
example, statements concerning the expected benefits of the
ProParaflu+ assay, its commercial uptake, and the duration of the
current influenza public health emergency are all forward-looking
statements. Forward-looking statements are not guarantees of
performance. They involve known and unknown risks, uncertainties
and assumptions that may cause actual results, levels of activity,
performance or achievements to differ materially from those
expressed or implied. Some of these risks, uncertainties and
assumptions include, but are not limited to, the risk that
Gen-Probe will not commercialize the ProParaflu+ assay effectively.
The foregoing list sets forth some, but not all, of the factors
that could affect Gen-Probe's ability to achieve results described
in any forward-looking statements. For additional information about
risks and uncertainties Gen-Probe faces and a discussion of its
financial statements and footnotes, see documents filed with the
SEC, including the most recent annual report on Form 10-K and all
subsequent periodic reports. Gen-Probe assumes no obligation and
expressly disclaims any duty to update forward-looking statements
to reflect events or circumstances after the date of this news
release or to reflect the occurrence of subsequent events. Michael
Watts Vice president, investor relations and corporate
communications 858-410-8673 DATASOURCE: Gen-Probe Incorporated
CONTACT: Michael Watts, Vice president, investor relations and
corporate communications of Gen-Probe Incorporated, +1-858-410-8673
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