SAN DIEGO, August 23, 2010 /PRNewswire/ -- Gen-Probe
Incorporated (Nasdaq: GPRO) announced today that Prodesse's
ProFAST(TM)+ assay, a molecular test that simultaneously detects
and differentiates three common influenza A virus subtypes -
seasonal A/H1, seasonal A/H3, and 2009 H1N1 - has received its CE
(Conformité Européenne) Mark, enabling it to be commercialized in
the European Union.
"CE marking of our ProFAST+ assay is important for public
health, as the test enables physicians to accurately differentiate
among influenza A subtypes that have different antiviral
susceptibilities," said Eric Tardif,
general manager of Gen-Probe's Prodesse business. "In addition, the
ProFAST+ assay is the third of four new products that we expect our
recently expanded sales force to launch in Europe this year."
The ProFAST+ assay is a multiplex, real-time RT-PCR (polymerase
chain reaction) in vitro diagnostic test that detects influenza A
from nasopharyngeal swabs. It uses the same internal control and
format as other CE-marked Prodesse tests for respiratory infectious
diseases, and easily integrates into a laboratory's existing
workflow. All Prodesse products have been optimized for use with
automated extraction technology that minimizes technician hands-on
time. Test results can be obtained in as little as four hours using
the ProFAST+ assay, a significant improvement over culture-based
methods that can take days to produce a result.
Accurately differentiating among the three influenza A subtypes
is important because each subtype has a different susceptibility to
commonly used influenza antiviral drugs. For example, seasonal H1
has become resistant to the antiviral drug oseltamivir, whereas
most cases of 2009 H1N1 and seasonal H3N2 respond to
oseltamivir.
The ProFAST+ assay complements the Prodesse ProFlu(TM)+ assay,
which has been CE-marked to detect and differentiate influenza A,
influenza B, and respiratory syncytial virus (RSV). The ProFlu+
assay identifies samples containing 2009 H1N1 as influenza A, but
unlike the ProFAST+ test, it does not differentiate among the
various influenza A subtypes.
About Gen-Probe
Gen-Probe Incorporated is a global leader in the development,
manufacture and marketing of rapid, accurate and cost-effective
molecular diagnostic products and services that are used primarily
to diagnose human diseases, screen donated human blood, and ensure
transplant compatibility. Gen-Probe has approximately 27 years of
expertise in nucleic acid testing (NAT), and received the 2004
National Medal of Technology, America's highest honor for
technological innovation, for developing NAT assays for blood
screening. Gen-Probe is headquartered in San Diego and employs approximately 1,300
people. For more information, go to http://www.gen-probe.com.
In October of last year, Gen-Probe acquired Prodesse, Inc.,
which is now a wholly owned subsidiary of Gen-Probe. Prodesse
develops molecular diagnostic reagents for a variety of infectious
diseases. Prodesse now sells five FDA 510(k) cleared products in
the United States, and two
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
ProFAST+ assay, its commercial acceptance, and future influenza
prevalence 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 ProFAST+
assay effectively, the risk that seasonal flu will not be prevalent
in this or future years, and the risk that 2009 H1N1 will not
return. 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.
Contact:
Michael Watts
Vice president, investor relations and corporate communications
+1-858-410-8673