SAN DIEGO, July 26 /PRNewswire-FirstCall/ -- Gen-Probe
Incorporated (Nasdaq: GPRO) announced today that the U.S. Food and
Drug Administration (FDA) has cleared for marketing Prodesse's
ProFAST™+ assay, making it the only FDA-cleared molecular
diagnostic test to simultaneously detect and differentiate three
common influenza A virus subtypes – seasonal A/H1, seasonal A/H3,
and 2009 H1N1.
"FDA clearance 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 Carl Hull,
Gen-Probe's president and CEO. "In addition, the ProFAST+
clearance kicks off what we believe will be an important new
revenue growth cycle for Gen-Probe, as its 510(k) was the first of
four U.S. regulatory applications that we expect to submit before
year-end."
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 FDA-cleared 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™+ assay,
which was cleared by the FDA in 2008 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 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. With the FDA clearance of ProFAST+, Prodesse now
sells five FDA 510(k) cleared products in the United States, and one additional
CE-marked product 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:
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Michael Watts
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Vice president, investor
relations and corporate communications
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858-410-8673
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SOURCE Gen-Probe Incorporated