Gen-Probe Files US Regulatory Application for Molecular Test to Detect Common Sexually Transmitted Disease Trichomonas Vaginalis
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 APTIMAÃ‚® Trichomonas vaginalis assay on the fully automated TIGRISÃ‚® 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.
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: Michael Watts Vice president, investor relations and corporate communications 858-410-8673
SOURCE Gen-Probe Incorporated