SAN DIEGO, June 30 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that it has received a European CE mark for its APTIMA® 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® 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.
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.
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.
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