SAN DIEGO, Oct. 4 /PRNewswire-FirstCall/ -- Gen-Probe
Incorporated (Nasdaq: GPRO) announced today that the Company has
submitted a 510(k) application to the US Food and Drug
Administration (FDA) for its APTIMA® Trichomonas vaginalis
assay on the fully automated TIGRIS® system.
"Trichomonas is the most common curable sexually transmitted
disease in young women, and it can lead to serious health
consequences if left untreated," said Carl
Hull, Gen-Probe's president and chief executive officer.
"We believe our Trichomonas vaginalis assay
will contribute significantly to women's health and provide a
convenient tool for physicians and laboratories. Our assay
employs the same technology as our market-leading APTIMA tests for
Chlamydia and gonorrhea, can be used with the same female samples,
and runs on our unique, fully automated TIGRIS system.
"In addition, this regulatory application represents the third
of five that we plan to complete in the
United States this year. Taken together, we expect
these new products to start an important new sales growth cycle for
the Company."
Trichomonas is a sexually transmitted parasite that causes
vaginitis, urethritis and cervicitis in women. If left
untreated, complications can include premature labor,
low-birth-weight offspring, and premature membrane rupture in
pregnancy. Studies have shown that Trichomonas infection also
makes women more susceptible to infection with HIV-1, the virus
that causes AIDS, and contributes to increased persistence of the
Human Papillomavirus (HPV), which causes cervical cancer. The
US Centers for Disease Control estimate that 7.4 million American
men and women are infected with Trichomonas annually, making it
more prevalent than Chlamydia and gonorrhea combined.
Screening for Trichomonas is limited today due in part to the
shortfalls of current testing techniques. Most testing
currently is done via culture methods, which are slow and less
sensitive than molecular tests, or "wet mount," which requires the
microscopic examination of a sample shortly after it is
collected.
Gen-Probe's APTIMA Trichomonas vaginalis assay has been
CE marked for sale in the European Union, but has not been cleared
for marketing in the United
States.
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.
Caution Regarding Forward-Looking Statements
Any statements in this press release about 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 new products,
potential regulatory approvals, customer adoption, and results of
future R&D studies 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. These risks, uncertainties and
assumptions include, but are not limited to: (i) the risk that new
products, such as our APTIMA Trichomonas vaginalis assay,
will not be cleared for marketing in the timeframe we expect, if at
all, (ii) the possibility that the market for the sale of our new
products, such as our APTIMA Trichomonas vaginalis assay,
may not develop as expected, and (iii) the risk that we may not be
able to compete effectively. The foregoing describes some,
but not all, of the factors that could affect our ability to
achieve results described in any forward-looking statements.
For additional information about risks and uncertainties we
face and a discussion of our financial statements and footnotes,
see documents we file with the SEC, including our most recent
annual report on Form 10-K and all subsequent periodic reports.
We assume no obligation and expressly disclaim any duty to
update any forward-looking statement 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
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corporate
communications
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858-410-8673
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SOURCE Gen-Probe Incorporated
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