SAN DIEGO, April 20, 2011 /PRNewswire/ -- Gen-Probe
Incorporated (NASDAQ: GPRO) announced today that the US Food and
Drug Administration (FDA) has cleared for marketing its APTIMA®
Trichomonas vaginalis assay on the fully automated TIGRIS®
system.
The APTIMA assay is the first amplified nucleic acid test
specifically cleared to detect Trichomonas vaginalis, the
most common curable sexually transmitted infection in the United States. The assay may be used
to test clinician-collected endocervical or vaginal swabs, urine,
and specimens collected in PreservCyt solution from symptomatic or
asymptomatic women.
"We believe our APTIMA Trichomonas assay will improve detection
of a potentially serious sexually transmitted infection that is
common in women of all ages," said Carl
Hull, Gen-Probe's president and chief executive officer.
"Our assay will provide a convenient tool for physicians and
laboratories because it employs the same technology as our
market-leading tests for Chlamydia and gonorrhea, can be used with
the same female samples, and runs on our unique, fully automated
TIGRIS system."
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. The US Centers for Disease Control estimate that
7.4 million American men and women are infected with Trichomonas
annually.
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
and is even less sensitive than culture.
About Gen-Probe
Gen-Probe 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 28
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 1,400
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,
customer adoption, and future sales 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 the
market for the sale of our new products, such as our APTIMA
Trichomonas vaginalis assay, may not develop as expected;
(ii) the risk that we may not be able to compete effectively; and
(iii) the risk that future R&D studies will not be positive.
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
Vice president, investor
relations and
corporate
communications
858-410-8673
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SOURCE Gen-Probe Incorporated