Gen-Probe Receives European CE Mark for Molecular Test to Detect Common Sexually Transmitted Disease Trichomonas Vaginalis
By Gen-probe Incorporated, PRNETuesday, June 29, 2010
SAN DIEGO, June 30, 2010 - Gen-Probe Incorporated (Nasdaq: GPRO) announced today that it has
received a European CE mark for its APTIMA(R) assay for Trichomonas
vaginalis, a common parasitic sexually transmitted disease.
Gen-Probe's APTIMA Trichomonas assay utilizes the same nucleic acid
amplification technologies as the APTIMA COMBO 2(R) assay, the Company's
market-leading test for chlamydia and gonorrhea, and studies have shown that
Gen-Probe's Transcription-Mediated Amplification (TMA) technology provides
greater sensitivity than existing tests for Trichomonas vaginalis. In
addition, the APTIMA Trichomonas assay may be used on the fully automated
TIGRIS system to test the same female specimens as those used with the APTIMA
COMBO 2 assay, which makes testing more convenient for physicians and
laboratories.
"Trichomoniasis is a common sexually transmitted infection that can lead
to serious health consequences in the genital tract if left untreated," said
Dr. Angelika Stary, University Professor, Outpatient Center for STD
Diagnosis, Vienna, Austria. "The APTIMA Trichomonas assay offers clinicians
and laboratorians a new method of detection that is significantly more
sensitive than current tests."
With this CE mark, Gen-Probe is allowed to market the assay in European
Union countries. The test has not been cleared for marketing in the United
States, but the Company has completed its US clinical trial and remains on
track to submit a regulatory application later this year.
About Trichomonas vaginalis
Trichomonas vaginalis is a sexually transmitted parasite that can cause
vaginitis, urethritis, premature membrane rupture in pregnancy, and increased
persistence of the Human Papillomavirus (HPV), which causes cervical cancer.
Trichomonas vaginalis also makes women more susceptible to infection with
HIV-1.
The World Health Organization (WHO) estimates that there are 180 million
new cases of Trichomonas vaginalis infection annually worldwide, with over 10
million of those new cases occurring in Europe, making it more prevalent than
chlamydia and gonorrhea combined.
Screening for Trichomonas vaginalis is limited today, due in part to the
limitations of traditional testing techniques such as culture and wet mount
microscopy, which are much less sensitive than molecular tests.
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 by any forward-looking
statement. Some of the risks, uncertainties and assumptions that could cause
actual results to differ materially from estimates or projections contained
in the forward-looking statements 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 other markets in the timeframes 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, (iii) we may not be able to compete effectively, and (iv) we are
dependent on third parties for the distribution of some of our products. 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: Jori Tulkki Associate director, government and corporate affairs +1-858-410-8660
Jori Tulkki, Associate director, government and corporate affairs of Gen-Probe Incorporated, +1-858-410-8660
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